S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma

Sponsor

Southwest Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00822120

Collaborator

National Cancer Institute (NCI) (NIH)

371

Enrollment

423

Locations

Arms

156

Duration (Months)

0.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. G-CSF may help lessen the side effects in patients receiving chemotherapy. Imaging procedures, such as fludeoxyglucose F 18-PET/CT imaging, may help doctors predict how patients will respond to treatment.

PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well it works in assessing response to combination chemotherapy and allow doctors to plan better additional further treatment in treating patients with stage III or stage IV Hodgkin lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma Nonneoplastic Condition	Biological: bleomycin sulfate Biological: filgrastim Drug: ABVD regimen Drug: BEACOPP regimen Drug: cyclophosphamide Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisone Drug: procarbazine hydrochloride Drug: vinblastine sulfate Drug: vincristine sulfate	Phase 2

Detailed Description

OBJECTIVES:

Primary

To estimate the 2-year progression-free survival (PFS) of HIV-negative patients with stage III-IV Hodgkin lymphoma treated with response-adapted therapy based on fludeoxyglucose F 18 (FDG)-PET imaging after 2 courses of doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine (ABVD).
To estimate the 2-year PFS of patients who are PET-positive after treatment with 2 courses of ABVD and an escalated dose regimen comprising cyclophosphamide, doxorubicin hydrochloride, etoposide, vincristine sulfate, bleomycin, procarbazine hydrochloride, and prednisone (BEACOPP).

Secondary

To estimate the 2-year overall survival (OS) of patients treated with these regimens.
To estimate the response rate (i.e., complete and partial responses) in patients treated with these regimens.
To evaluate the toxicity of these response-adapted regimens.
To document the feasibility of centralized, real-time review of FDG-PET imaging for U.S. cooperative group studies.
To prospectively evaluate the overall response rate, complete response rate, PFS, and OS of HIV-positive patients treated with these response-adapted regimens.

OUTLINE: This is a multicenter study.

All patients undergo baseline whole-body fludeoxyglucose F 18 (FDG)-PET/CT imaging before beginning chemotherapy. Patients then receive doxorubicin hydrochloride IV, bleomycin IV, vinblastine IV, and dacarbazine IV (ABVD) on days 1 and 15. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Between days 22 and 25 of course 2, patients undergo a second FDG-PET/CT scan to assess response. Subsequent therapy is based on FDG-PET/CT scan results. Patients are stratified according to FDG-PET positivity (yes vs no). Patients who are FDG-PET-negative continue treatment with ABVD for up to 4 additional courses in the absence of disease progression or unacceptable toxicity. Patients who are FDG-PET-positive are then further stratified according to HIV positivity (yes or no) and receive 1 of the following treatment regimens:

Escalated-dose BEACOPP chemotherapy: HIV-negative patients receive escalated-dose BEACOPP chemotherapy comprising doxorubicin hydrochloride IV and cyclophosphamide IV on day 1, etoposide IV on days 1-3, oral procarbazine hydrochloride on days 1-7, oral prednisone on days 1-14, and bleomycin IV and vincristine IV on day 8. Patients receive filgrastim (G-CSF) subcutaneously on days 8-14. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Standard-dose BEACOPP chemotherapy: HIV-positive patients receive standard dose BEACOPP chemotherapy comprising doxorubicin hydrochloride IV and cyclophosphamide IV on day 1, etoposide IV on days 1-3, oral procarbazine hydrochloride on days 1-7, oral prednisone on days 1-14, and bleomycin IV and vincristine IV on day 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Six to eight weeks after completion of chemotherapy, patients undergo a post-treatment FDG-PET/CT scan.

Some patients may undergo bone marrow biopsy at 1 month after the last course of chemotherapy.

After completion of study treatment, patients are followed up periodically for 7 years.

Study Design

Study Type:

Interventional

Actual Enrollment :

371 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Apr 30, 2016

Actual Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HIV Positive, PET Positive: BEACOPP standard Etoposide 100 mg/m2 IV Days 1, 2, 3 Dox 25 mg/m2 IV Day 1 Cyclo 650mg/m2 IV Day 1 Procarb 100 mg/m2 PO Days 1-7 Pred 40 mg/m2 PO Days 1-14 Bleo 10u/m2 IV Day 8 Vincristine 1.4 mg/m2 IV Day 8 Q 21 Days x 6 cycles	Biological: bleomycin sulfate Drug: BEACOPP regimen Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisone Drug: procarbazine hydrochloride Drug: vincristine sulfate
Experimental: HIV Negative, PET Positive: BEACOPP escalated Etoposide 200 mg/m2 IV Days 1, 2, 3 Dox 35 mg/m2 IV Day 1 Cyclo 1,250 mg/m2 IV Day 1 Procarb 100 mg/m2 PO Days 1-7 Pred 40 mg/m2 PO Days 1-14 Bleo 10u/m2 IV Day 8 Vincristine 1.4 mg/m2 IV Day 8 G-CSF 5mcg/kg/day SQ Days 8-14 Q 21 Days x 6 cycles	Biological: bleomycin sulfate Biological: filgrastim Drug: BEACOPP regimen Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisone Drug: procarbazine hydrochloride Drug: vincristine sulfate
Active Comparator: HIV Positive, PET Negative: ABVD Doxorubicin 25 mg/m2 IV Bleomycin 10u/m2 IV Vinblastine 6mg/m2 IV Dacarbazine 375 mg/m2 IV Days 1, 15 Q 28 Days x 2	Biological: bleomycin sulfate Drug: ABVD regimen Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: vinblastine sulfate
Active Comparator: HIV Negative, PET Negative: ABVD Doxorubicin 25 mg/m2 IV Bleomycin 10u/m2 IV Vinblastine 6mg/m2 IV Dacarbazine 375 mg/m2 IV Days 1, 15 Q 28 Days x 2	Biological: bleomycin sulfate Drug: ABVD regimen Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: vinblastine sulfate

Outcome Measures

Primary Outcome Measures

Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging. [2 years]
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is > 1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS [2 years]
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is > 1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.

Secondary Outcome Measures

Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging [2 years]
Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.
Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD [7 months after registration]
Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [Up to 1 year]
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging. [2 years]
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is >1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging. [5 years]
Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.
Complete and Partial Response Rates for HIV-positive Patients Treated With Response-Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD [7 months after registration]
Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [Up to 1 year]
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed classical Hodgkin lymphoma (HL) (i.e., nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted)
Previously untreated stage III or IV disease
No nodular lymphocyte predominant disease
Bidimensionally measurable disease
Adequate biopsy samples from original diagnostic specimen must be available for pathologic review
Tissue obtained from core biopsies allowed
No tissue obtained from needle aspirations or cytologies
Must have known HIV status
No multi-drug resistant HIV infection, CD4 counts < 150/μL, or other concurrent AIDS-defining conditions in HIV-positive patients
HIV-positive patients with CD4 counts ≥ 150/μL at the time of enrollment OR documented CD4 count > 250/μL at any time within 8 months prior to HL diagnosis allowed
Must have undergone unilateral or bilateral bone marrow biopsy within the past 42 days
Must have a diagnostic quality CT scan of the chest/abdomen and pelvis AND baseline FDG-PET scan within the past 28 days
Combined PET/CT scans required
No older "stand-alone" FDG-PET scans
No low-resolution "localization" CT scans as part of a combined PET/CT scans

PATIENT CHARACTERISTICS:

Zubrod performance status 0-2
Serum erythrocyte sedimentation rate, lactate dehydrogenase (LDH), hemoglobin, albumin, white blood cell count (WBC), and lymphocytes measured within the past 28 days
Serum estradiol (women only), testosterone (men only), follicle stimulating hormone (FSH) and luteinizing hormone (LH) (both men and women) levels must be drawn within 60 days prior to registration
Not pregnant or nursing
Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
No significant cardiac abnormalities as assessed by multiple gated acquisition scan (MUGA) or ECHO AND cardiac ejection fraction ≥ 45% in patients with a history of hypertension or cardiac symptoms
Hepatitis B-negative (i.e., hepatitis B surface antigen-negative or anti-hepatitis B core antigen-negative)
Patients immune to or immunized against hepatitis B (i.e., anti-hepatitis B surface antibody-positive) are eligible
Hepatitis C-negative (i.e., anti-hepatitis C antibody-negative)
No significant lung disease with abnormal lung function tests (i.e., diffusing capacity of lung for carbon monoxide (DLCO) > 25% below predicted after correction for hemoglobin) unless attributable to lymphoma
No requirement for continuous supplemental oxygen therapy
No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma
No prior solid organ transplantation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Cancer Center at University Medical Center North	Tucson	Arizona	United States	85719
2	Arizona Cancer Center at University of Arizona Health Sciences Center	Tucson	Arizona	United States	85724-5024
3	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
4	Highlands Oncology Group - Springdale	Rogers	Arkansas	United States	72758
5	Kaiser Permanente Medical Center - Anaheim/Orange County	Anaheim	California	United States	92807
6	Kaiser Permanente - Deer Valley	Antioch	California	United States	94531
7	Kaiser Permanente Medical Center - Baldwin Park	Baldwin Park	California	United States	91706
8	Kaiser Permanente Medical Center - Bellflower	Bellflower	California	United States	90706
9	City of Hope Comprehensive Cancer Center	Duarte	California	United States	91010-3000
10	Kaiser Permanente Medical Center - Fontana	Fontana	California	United States	92335
11	Kaiser Permanente - Fremont	Fremont	California	United States	94538
12	Kaiser Permanente Fresno Medical Center	Fresno	California	United States	93720
13	Kaiser Permanente Medical Center - Harbor City	Harbor City	California	United States	90710
14	Kaiser Permanente Medical Center - Hayward	Hayward	California	United States	94545
15	Kaiser Permanente - Irvine	Irvine	California	United States	92618
16	Rebecca and John Moores UCSD Cancer Center	La Jolla	California	United States	92093-0658
17	Kaiser Permanente Medical Center - Los Angeles	Los Angeles	California	United States	90027
18	Kaiser Foundation Hospital - West Los Angeles	Los Angeles	California	United States	90034
19	Kaiser Permanente Medical Center - Oakland	Oakland	California	United States	94611
20	Kaiser Permanente Medical Group	Panorama City	California	United States	91402
21	Kaiser Permanente Medical Center - Redwood City	Redwood City	California	United States	94063
22	Kaiser Permanente Medical Center - Richmond	Richmond	California	United States	94801
23	Kaiser Permanente Medical Center - Riverside	Riverside	California	United States	92505
24	Kaiser Permanente Medical Center - Roseville	Roseville	California	United States	95661
25	University of California Davis Cancer Center	Sacramento	California	United States	95817
26	South Sacramento Kaiser-Permanente Medical Center	Sacramento	California	United States	95823
27	Kaiser Permanente Medical Center - Sacramento	Sacramento	California	United States	95825
28	Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego	San Diego	California	United States	92120
29	Kaiser Permanente Medical Center - San Francisco Geary Campus	San Francisco	California	United States	94115
30	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California	United States	94115
31	Kaiser Permanente Medical Center - Santa Teresa	San Jose	California	United States	95119
32	Kaiser Permanente Health Care	San Marcos	California	United States	92078
33	Kaiser Foundation Hospital - San Rafael	San Rafael	California	United States	94903
34	Kaiser Permanente Medical Center - Santa Clara Kiely Campus	Santa Clara	California	United States	95051
35	Kaiser Permanente Medical Center - Santa Rosa	Santa Rosa	California	United States	95403
36	Kaiser Permanente Medical Center - South San Francisco	South San Francisco	California	United States	94080
37	Stanford Cancer Center	Stanford	California	United States	94305-5824
38	Kaiser Permanente Medical Facility - Stockton	Stockton	California	United States	95210
39	Kaiser Permanente Medical Center - Vacaville	Vacaville	California	United States	95688
40	Kaiser Permanente Medical Center - Vallejo	Vallejo	California	United States	94589
41	Kaiser Permanente Medical Center - Walnut Creek	Walnut Creek	California	United States	94596
42	Kaiser Permanente Medical Cener - Woodland Hills	Woodland Hills	California	United States	91367
43	Aurora Presbyterian Hospital	Aurora	Colorado	United States	80012
44	Boulder Community Hospital	Boulder	Colorado	United States	80301-9019
45	Penrose Cancer Center at Penrose Hospital	Colorado Springs	Colorado	United States	80933
46	St. Anthony Central Hospital	Denver	Colorado	United States	80204
47	Kaiser Permanente - Denver	Denver	Colorado	United States	80205
48	Porter Adventist Hospital	Denver	Colorado	United States	80210
49	Presbyterian - St. Luke's Medical Center	Denver	Colorado	United States	80218
50	St. Joseph Hospital	Denver	Colorado	United States	80218
51	Rose Medical Center	Denver	Colorado	United States	80220
52	CCOP - Colorado Cancer Research Program	Denver	Colorado	United States	80222
53	Swedish Medical Center	Englewood	Colorado	United States	80110
54	Poudre Valley Hospital	Fort Collins	Colorado	United States	80524
55	Front Range Cancer Specialists	Fort Collins	Colorado	United States	80528
56	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center	Grand Junction	Colorado	United States	81502
57	North Colorado Medical Center	Greeley	Colorado	United States	80631
58	Kaiser Permanente - Lafayette	Lafayette	Colorado	United States	80026
59	Littleton Adventist Hospital	Littleton	Colorado	United States	80122
60	Sky Ridge Medical Center	Lone Tree	Colorado	United States	80124
61	Hope Cancer Care Center at Longmont United Hospital	Longmont	Colorado	United States	80501
62	McKee Medical Center	Loveland	Colorado	United States	80539
63	Parker Adventist Hospital	Parker	Colorado	United States	80138
64	St. Mary - Corwin Regional Medical Center	Pueblo	Colorado	United States	81004
65	North Suburban Medical Center	Thornton	Colorado	United States	80229
66	Exempla Lutheran Medical Center	Wheat Ridge	Colorado	United States	80033
67	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center	Hartford	Connecticut	United States	06105
68	Manchester Memorial Hospital	Manchester	Connecticut	United States	06040
69	Yale Cancer Center	New Haven	Connecticut	United States	06520-8028
70	Tunnell Cancer Center at Beebe Medical Center	Lewes	Delaware	United States	19958
71	CCOP - Christiana Care Health Services	Newark	Delaware	United States	19713
72	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington	District of Columbia	United States	20007
73	M.D. Anderson Cancer Center at Orlando	Orlando	Florida	United States	32806
74	Northeast Georgia Cancer Care, LLC - Medical Oncology	Athens	Georgia	United States	30607
75	Winship Cancer Institute of Emory University	Atlanta	Georgia	United States	30322
76	MBCCOP - Medical College of Georgia Cancer Center	Augusta	Georgia	United States	30912
77	Kapiolani Medical Center at Pali Momi	'Aiea	Hawaii	United States	96701
78	Cancer Research Center of Hawaii	Honolulu	Hawaii	United States	96813
79	OnCare Hawaii, Incorporated - Lusitana	Honolulu	Hawaii	United States	96813
80	Queen's Cancer Institute at Queen's Medical Center	Honolulu	Hawaii	United States	96813
81	Straub Clinic and Hospital, Incorporated	Honolulu	Hawaii	United States	96813
82	Hawaii Medical Center - East	Honolulu	Hawaii	United States	96817
83	OnCare Hawaii, Incorporated - Kuakini	Honolulu	Hawaii	United States	96817
84	Kaiser Permanente - Moanalua Medical Center and Clinic	Honolulu	Hawaii	United States	96819
85	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii	United States	96826
86	Tripler Army Medical Center	Honolulu	Hawaii	United States	96859
87	Castle Medical Center	Kailua	Hawaii	United States	96734
88	Kauai Medical Clinic	Lihue	Hawaii	United States	96766
89	Maui Memorial Medical Center	Wailuku	Hawaii	United States	96793
90	Pacific Cancer Institute - Maui	Wailuku	Hawaii	United States	96793
91	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center	Boise	Idaho	United States	83706
92	St. Joseph Regional Medical Center	Lewiston	Idaho	United States	83501
93	Idaho Urologic Institute, PA	Meridian	Idaho	United States	83642
94	Illinois CancerCare - Bloomington	Bloomington	Illinois	United States	61701
95	St. Joseph Medical Center	Bloomington	Illinois	United States	61701
96	Graham Hospital	Canton	Illinois	United States	61520
97	Illinois CancerCare - Canton	Canton	Illinois	United States	61520
98	Illinois CancerCare - Carthage	Carthage	Illinois	United States	62321
99	Memorial Hospital	Carthage	Illinois	United States	62321
100	John H. Stroger, Jr. Hospital of Cook County	Chicago	Illinois	United States	60612-3785
101	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
102	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois	United States	62526
103	Sherman Hospital	Elgin	Illinois	United States	60123
104	Eureka Community Hospital	Eureka	Illinois	United States	61530
105	Illinois CancerCare - Eureka	Eureka	Illinois	United States	61530
106	Galesburg Clinic, PC	Galesburg	Illinois	United States	61401
107	Illinois CancerCare - Galesburg	Galesburg	Illinois	United States	61401
108	Delnor Hospital - Geneva	Geneva	Illinois	United States	60134
109	Illinois CancerCare - Havana	Havana	Illinois	United States	62644
110	Illinois CancerCare - Kewanee Clinic	Kewanee	Illinois	United States	61443
111	Illinois CancerCare - Macomb	Macomb	Illinois	United States	61455
112	McDonough District Hospital	Macomb	Illinois	United States	61455
113	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois	United States	60153
114	Illinois CancerCare - Monmouth	Monmouth	Illinois	United States	61462
115	OSF Holy Family Medical Center	Monmouth	Illinois	United States	61462
116	BroMenn Regional Medical Center	Normal	Illinois	United States	61761
117	Community Cancer Center	Normal	Illinois	United States	61761
118	Illinois CancerCare - Community Cancer Center	Normal	Illinois	United States	61761
119	Community Hospital of Ottawa	Ottawa	Illinois	United States	61350
120	Oncology Hematology Associates of Central Illinois, PC - Ottawa	Ottawa	Illinois	United States	61350
121	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois	United States	61554
122	Illinois CancerCare - Pekin	Pekin	Illinois	United States	61603
123	Proctor Hospital	Peoria	Illinois	United States	61614
124	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61615
125	Oncology Hematology Associates of Central Illinois, PC - Peoria	Peoria	Illinois	United States	61615
126	Methodist Medical Center of Illinois	Peoria	Illinois	United States	61636
127	OSF St. Francis Medical Center	Peoria	Illinois	United States	61637
128	Illinois CancerCare - Peru	Peru	Illinois	United States	61354
129	Illinois Valley Community Hospital	Peru	Illinois	United States	61354
130	Illinois CancerCare - Princeton	Princeton	Illinois	United States	61356
131	Perry Memorial Hospital	Princeton	Illinois	United States	61356
132	Illinois CancerCare - Spring Valley	Spring Valley	Illinois	United States	61362
133	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois	United States	62781-0001
134	Central Dupage Cancer Center	Warrenville	Illinois	United States	60555
135	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana	United States	46107
136	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana	United States	46845
137	Reid Hospital & Health Care Services	Richmond	Indiana	United States	47374
138	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa	United States	51101
139	Mercy Medical Center - Sioux City	Sioux City	Iowa	United States	51102
140	St. Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
141	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas	United States	66720
142	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas	United States	67801
143	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas	United States	67042
144	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas	United States	66701
145	Cancer Center of Kansas-Independence	Independence	Kansas	United States	67301
146	Providence Medical Center	Kansas City	Kansas	United States	66112
147	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas	United States	67068
148	Lawrence Memorial Hospital	Lawrence	Kansas	United States	66044
149	Cancer Center of Kansas, PA - Liberal	Liberal	Kansas	United States	67901
150	Cancer Center of Kansas, PA - McPherson	McPherson	Kansas	United States	67460
151	Cancer Center of Kansas, PA - Newton	Newton	Kansas	United States	67114
152	Menorah Medical Center	Overland Park	Kansas	United States	66209
153	Saint Luke's Hospital - South	Overland Park	Kansas	United States	66213
154	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas	United States	67357
155	CCOP - Kansas City	Prairie Village	Kansas	United States	66208
156	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas	United States	67124
157	Cancer Center of Kansas, PA - Salina	Salina	Kansas	United States	67401
158	Tammy Walker Cancer Center at Salina Regional Health Center	Salina	Kansas	United States	67401
159	Cotton-O'Neil Cancer Center	Topeka	Kansas	United States	66606
160	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas	United States	67152
161	Associates in Womens Health, PA - North Review	Wichita	Kansas	United States	67208
162	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas	United States	67208
163	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas	United States	67214
164	CCOP - Wichita	Wichita	Kansas	United States	67214
165	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
166	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas	United States	67156
167	Lucille P. Markey Cancer Center at University of Kentucky	Lexington	Kentucky	United States	40536-0093
168	Louisville Oncology at Norton Cancer Institute - Louisville	Louisville	Kentucky	United States	40202
169	Mary Bird Perkins Cancer Center - Baton Rouge	Baton Rouge	Louisiana	United States	70809
170	Ochsner Health Center - Bluebonnet	Baton Rouge	Louisiana	United States	70809
171	Ochsner Health Center - Covington	Covington	Louisiana	United States	70433
172	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
173	Medical Center of Louisiana - New Orleans	New Orleans	Louisiana	United States	70112
174	CCOP - Ochsner	New Orleans	Louisiana	United States	70121
175	Ochsner Cancer Institute at Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
176	Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Shreveport	Louisiana	United States	71130-3932
177	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland	United States	21201
178	Greater Baltimore Medical Center Cancer Center	Baltimore	Maryland	United States	21204
179	Alvin and Lois Lapidus Cancer Institute at Sinai Hospital	Baltimore	Maryland	United States	21215
180	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410
181	National Naval Medical Center	Bethesda	Maryland	United States	20889-5600
182	Union Hospital of Cecil County	Elkton	Maryland	United States	21921
183	Dana-Farber/Brigham and Women's Cancer Center	Boston	Massachusetts	United States	02115
184	Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
185	Boston University Cancer Research Center	Boston	Massachusetts	United States	02118
186	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
187	Addison Gilbert Hospital	Gloucester	Massachusetts	United States	01930
188	UMASS Memorial Cancer Center - University Campus	Worcester	Massachusetts	United States	01655
189	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan	United States	49221
190	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan	United States	48106-0995
191	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
192	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0942
193	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan	United States	49017
194	Mecosta County Medical Center	Big Rapids	Michigan	United States	49307
195	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48123-2500
196	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379
197	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan	United States	48202
198	Green Bay Oncology, Limited - Escanaba	Escanaba	Michigan	United States	49431
199	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
200	Hurley Medical Center	Flint	Michigan	United States	48503
201	Genesys Regional Medical Center	Grand Blanc	Michigan	United States	48439
202	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan	United States	49503
203	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
204	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan	United States	49503
205	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
206	Dickinson County Healthcare System	Iron Mountain	Michigan	United States	49801
207	Foote Memorial Hospital	Jackson	Michigan	United States	49201
208	Borgess Medical Center	Kalamazoo	Michigan	United States	49001
209	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007-3731
210	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
211	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48912-1811
212	St. Mary Mercy Hospital	Livonia	Michigan	United States	48154
213	Community Cancer Center of Monroe	Monroe	Michigan	United States	48162
214	Mercy Memorial Hospital - Monroe	Monroe	Michigan	United States	48162
215	Mercy General Health Partners	Muskegon	Michigan	United States	49444
216	St. Joseph Mercy Oakland	Pontiac	Michigan	United States	48341-2985
217	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan	United States	48060
218	Spectrum Health Reed City Hospital	Reed City	Michigan	United States	49677
219	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan	United States	48601
220	Munson Medical Center	Traverse City	Michigan	United States	49684
221	St. John Macomb Hospital	Warren	Michigan	United States	48093
222	Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
223	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota	United States	55433
224	Duluth Clinic Cancer Center - Duluth	Duluth	Minnesota	United States	55805-1983
225	CCOP - Duluth	Duluth	Minnesota	United States	55805
226	Miller - Dwan Medical Center	Duluth	Minnesota	United States	55805
227	Fairview Southdale Hospital	Edina	Minnesota	United States	55435
228	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota	United States	55432
229	Hutchinson Area Health Care	Hutchinson	Minnesota	United States	55350
230	HealthEast Cancer Care at St. John's Hospital	Maplewood	Minnesota	United States	55109
231	Minnesota Oncology - Maplewood	Maplewood	Minnesota	United States	55109
232	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital	Minneapolis	Minnesota	United States	55407
233	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55415
234	New Ulm Medical Center	New Ulm	Minnesota	United States	56073
235	Humphrey Cancer Center at North Memorial Outpatient Center	Robbinsdale	Minnesota	United States	55422-2900
236	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
237	Park Nicollet Cancer Center	Saint Louis Park	Minnesota	United States	55416
238	Regions Hospital Cancer Care Center	Saint Paul	Minnesota	United States	55101
239	United Hospital	Saint Paul	Minnesota	United States	55102
240	St. Francis Cancer Center at St. Francis Medical Center	Shakopee	Minnesota	United States	55379
241	Lakeview Hospital	Stillwater	Minnesota	United States	55082
242	Ridgeview Medical Center	Waconia	Minnesota	United States	55387
243	Willmar Cancer Center at Rice Memorial Hospital	Willmar	Minnesota	United States	56201
244	Minnesota Oncology - Woodbury	Woodbury	Minnesota	United States	55125
245	Saint Luke's Cancer Institute at Saint Luke's Hospital	Kansas City	Missouri	United States	64111
246	North Kansas City Hospital	Kansas City	Missouri	United States	64116
247	Heartland Hematology Oncology Associates, Incorporated	Kansas City	Missouri	United States	64118
248	Research Medical Center	Kansas City	Missouri	United States	64132
249	Saint Luke's East - Lee's Summit	Lee's Summit	Missouri	United States	64086
250	Parvin Radiation Oncology	Liberty	Missouri	United States	64068
251	Heartland Regional Medical Center	Saint Joseph	Missouri	United States	64506
252	Saint Joseph Oncology, Incorporated	Saint Joseph	Missouri	United States	64507
253	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri	United States	63110
254	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65802
255	St. John's Regional Health Center	Springfield	Missouri	United States	65804
256	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri	United States	65807
257	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
258	St. Vincent Healthcare Cancer Care Services	Billings	Montana	United States	59101
259	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59102
260	Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
261	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
262	St. James Healthcare Cancer Care	Butte	Montana	United States	59701
263	Great Falls Clinic - Main Facility	Great Falls	Montana	United States	59405
264	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana	United States	59405
265	St. Peter's Hospital	Helena	Montana	United States	59601
266	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
267	Kalispell Medical Oncology at KRMC	Kalispell	Montana	United States	59901
268	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
269	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
270	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
271	UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-6805
272	University Medical Center of Southern Nevada	Las Vegas	Nevada	United States	89102
273	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
274	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756-0002
275	Cancer Institute of New Jersey at Hamilton	Hamilton	New Jersey	United States	08690
276	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08903
277	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey	United States	08043
278	University of New Mexico Cancer Center	Albuquerque	New Mexico	United States	87131-5636
279	Albert Einstein Cancer Center at Albert Einstein College of Medicine	Bronx	New York	United States	10461
280	Tucker Center for Cancer Care at Orange Regional Medical Center	Middletown	New York	United States	10940-4199
281	Beth Israel Medical Center - Petrie Division	New York	New York	United States	10003-3803
282	St. Luke's - Roosevelt Hospital Center - St.Luke's Division	New York	New York	United States	10025
283	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10065
284	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York	United States	14642
285	SUNY Upstate Medical University Hospital	Syracuse	New York	United States	13210
286	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
287	FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center	Pinehurst	North Carolina	United States	28374
288	Rutherford Hospital	Rutherfordton	North Carolina	United States	28139
289	Iredell Memorial Hospital	Statesville	North Carolina	United States	28677
290	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina	United States	27157-1096
291	Medcenter One Hospital Cancer Care Center	Bismarck	North Dakota	United States	58501
292	Mid Dakota Clinic, PC	Bismarck	North Dakota	United States	58501
293	St. Alexius Medical Center Cancer Center	Bismarck	North Dakota	United States	58502
294	Summa Center for Cancer Care at Akron City Hospital	Akron	Ohio	United States	44309-2090
295	Barberton Citizens Hospital	Barberton	Ohio	United States	44203
296	Wood County Oncology Center	Bowling Green	Ohio	United States	43402
297	Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106-5065
298	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
299	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center	Columbus	Ohio	United States	43210-1240
300	Grandview Hospital	Dayton	Ohio	United States	45405
301	Good Samaritan Hospital	Dayton	Ohio	United States	45406
302	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio	United States	45409
303	Samaritan North Cancer Care Center	Dayton	Ohio	United States	45415
304	CCOP - Dayton	Dayton	Ohio	United States	45420
305	Community Cancer Center	Elyria	Ohio	United States	44035
306	Hematology Oncology Center	Elyria	Ohio	United States	44035
307	Blanchard Valley Medical Associates	Findlay	Ohio	United States	45840
308	Middletown Regional Hospital	Franklin	Ohio	United States	45005-1066
309	Wayne Hospital	Greenville	Ohio	United States	45331
310	Charles F. Kettering Memorial Hospital	Kettering	Ohio	United States	45429
311	Lima Memorial Hospital	Lima	Ohio	United States	45804
312	Northwest Ohio Oncology Center	Maumee	Ohio	United States	43537-1839
313	St. Charles Mercy Hospital	Oregon	Ohio	United States	43616
314	Toledo Clinic - Oregon	Oregon	Ohio	United States	43616
315	Flower Hospital Cancer Center	Sylvania	Ohio	United States	43560
316	Mercy Hospital of Tiffin	Tiffin	Ohio	United States	44883
317	Toledo Hospital	Toledo	Ohio	United States	43606
318	St. Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
319	Medical University of Ohio Cancer Center	Toledo	Ohio	United States	43614
320	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43617
321	St. Anne Mercy Hospital	Toledo	Ohio	United States	43623
322	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio	United States	43623
323	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio	United States	45373-1300
324	Fulton County Health Center	Wauseon	Ohio	United States	43567
325	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio	United States	45385
326	Clackamas Radiation Oncology Center	Clackamas	Oregon	United States	97015
327	Legacy Mount Hood Medical Center	Gresham	Oregon	United States	97030
328	Providence Milwaukie Hospital	Milwaukie	Oregon	United States	97222
329	Providence Newberg Medical Center	Newberg	Oregon	United States	97132
330	Willamette Falls Hospital	Oregon City	Oregon	United States	97045
331	Legacy Good Samaritan Hospital & Comprehensive Cancer Center	Portland	Oregon	United States	97210
332	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon	United States	97213-2967
333	CCOP - Columbia River Oncology Program	Portland	Oregon	United States	97225
334	Providence St. Vincent Medical Center	Portland	Oregon	United States	97225
335	Legacy Emanuel Hospital and Health Center and Children's Hospital	Portland	Oregon	United States	97227
336	Legacy Meridian Park Hospital	Tualatin	Oregon	United States	97062
337	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania	United States	18105
338	Geisinger Cancer Institute at Geisinger Health	Danville	Pennsylvania	United States	17822-0001
339	Geisinger Hazleton Cancer Center	Hazleton	Pennsylvania	United States	18201
340	Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
341	Lewistown Hospital	Lewistown	Pennsylvania	United States	17044
342	Joan Karnell Cancer Center at Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19107
343	Geisinger Medical Group - Scenery Park	State College	Pennsylvania	United States	16801
344	Mount Nittany Medical Center	State College	Pennsylvania	United States	16803
345	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania	United States	18711
346	AnMed Cancer Center	Anderson	South Carolina	United States	29621
347	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina	United States	29425
348	Bon Secours St. Francis Health System	Greenville	South Carolina	United States	29601
349	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
350	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
351	Sanford Cancer Center at Sanford USD Medical Center	Sioux Falls	South Dakota	United States	57117-5039
352	West Tennessee Cancer Center at Jackson-Madison County General Hospital	Jackson	Tennessee	United States	38301
353	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6838
354	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas	United States	75390
355	M. D. Anderson Cancer Center at University of Texas	Houston	Texas	United States	77030-4009
356	Mountainview Medical	Berlin	Vermont	United States	05602
357	Fletcher Allen Health Care - University Health Center Campus	Burlington	Vermont	United States	05401
358	Fredericksburg Oncology, Incorporated	Fredericksburg	Virginia	United States	22401
359	Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County	Martinsville	Virginia	United States	24115
360	Island Hospital Cancer Care Center at Island Hospital	Anacortes	Washington	United States	98221
361	Overlake Cancer Center at Overlake Hospital Medical Center	Bellevue	Washington	United States	98004
362	St. Joseph Cancer Center	Bellingham	Washington	United States	98225
363	Olympic Hematology and Oncology	Bremerton	Washington	United States	98310
364	Highline Medical Center Cancer Center	Burien	Washington	United States	98166
365	Providence Centralia Hospital	Centralia	Washington	United States	98531-9027
366	Providence Regional Cancer Partnership	Everett	Washington	United States	98201
367	St. Francis Hospital	Federal Way	Washington	United States	98003
368	Swedish Medical Center - Issaquah Campus	Issaquah	Washington	United States	98029
369	Columbia Basin Hematology	Kennewick	Washington	United States	99336
370	Skagit Valley Hospital Cancer Care Center	Mount Vernon	Washington	United States	98274
371	Providence St. Peter Hospital Regional Cancer Center	Olympia	Washington	United States	98506-5166
372	Harrison Poulsbo Hematology and Onocology	Poulsbo	Washington	United States	98370
373	Good Samaritan Cancer Center	Puyallup	Washington	United States	98372
374	Harborview Medical Center	Seattle	Washington	United States	98104
375	Minor and James Medical, PLLC	Seattle	Washington	United States	98104
376	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109
377	Group Health Central Hospital	Seattle	Washington	United States	98112
378	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington	United States	98122-4307
379	Polyclinic First Hill	Seattle	Washington	United States	98122
380	University Cancer Center at University of Washington Medical Center	Seattle	Washington	United States	98195
381	North Puget Oncology at United General Hospital	Sedro-Woolley	Washington	United States	98284
382	Cancer Care Northwest - Spokane South	Spokane	Washington	United States	99202
383	Evergreen Hematology and Oncology, PS	Spokane	Washington	United States	99218
384	Franciscan Cancer Center at St. Joseph Medical Center	Tacoma	Washington	United States	98405-3004
385	Allenmore Hospital	Tacoma	Washington	United States	98405
386	CCOP - Northwest	Tacoma	Washington	United States	98405
387	MultiCare Regional Cancer Center at Tacoma General Hospital	Tacoma	Washington	United States	98405
388	Madigan Army Medical Center - Tacoma	Tacoma	Washington	United States	98431
389	St. Clare Hospital	Tacoma	Washington	United States	98499
390	Southwest Washington Medical Center Cancer Center	Vancouver	Washington	United States	98664
391	Northwest Cancer Specialists at Vancouver Cancer Center	Vancouver	Washington	United States	98684
392	Legacy Salmon Creek Medical Center	Vancouver	Washington	United States	98686
393	Wenatchee Valley Medical Center	Wenatchee	Washington	United States	98801-2028
394	Mary Babb Randolph Cancer Center at West Virginia University Hospitals	Morgantown	West Virginia	United States	26506
395	Center for Cancer Treatment & Prevention at Sacred Heart Hospital	Eau Claire	Wisconsin	United States	54701
396	Marshfield Clinic Cancer Care at Regional Cancer Center	Eau Claire	Wisconsin	United States	54701
397	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54301-3526
398	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin	United States	54303
399	St. Mary's Hospital Medical Center - Green Bay	Green Bay	Wisconsin	United States	54303
400	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54307-3508
401	UW Cancer Center Johnson Creek	Johnson Creek	Wisconsin	United States	53038
402	Gundersen Lutheran Center for Cancer and Blood	La Crosse	Wisconsin	United States	54601
403	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin	United States	53792-6164
404	Holy Family Memorial Medical Center Cancer Care Center	Manitowoc	Wisconsin	United States	54221-1450
405	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin	United States	54143
406	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin	United States	54449
407	Saint Joseph's Hospital	Marshfield	Wisconsin	United States	54449
408	Marshfield Clinic - Lakeland Center	Minocqua	Wisconsin	United States	54548
409	D.N. Greenwald Center	Mukwonago	Wisconsin	United States	53149
410	Regional Cancer Center at Oconomowoc Memorial Hospital	Oconomowoc	Wisconsin	United States	53066
411	Green Bay Oncology, Limited - Oconto Falls	Oconto Falls	Wisconsin	United States	54154
412	Ministry Medical Group at Saint Mary's Hospital	Rhinelander	Wisconsin	United States	54501
413	Marshfield Clinic - Indianhead Center	Rice Lake	Wisconsin	United States	54868
414	St. Nicholas Hospital	Sheboygan	Wisconsin	United States	53081
415	Marshfield Clinic at Saint Michael's Hospital	Stevens Point	Wisconsin	United States	54481
416	Saint Michael's Hospital Cancer Center	Stevens Point	Wisconsin	United States	54481
417	Green Bay Oncology, Limited - Sturgeon Bay	Sturgeon Bay	Wisconsin	United States	54235
418	Waukesha Memorial Hospital Regional Cancer Center	Waukesha	Wisconsin	United States	53188
419	Diagnostic and Treatment Center	Weston	Wisconsin	United States	54476
420	Marshfield Clinic - Weston Center	Weston	Wisconsin	United States	54476
421	Ministry Saint Clare's Hospital	Weston	Wisconsin	United States	54476
422	Marshfield Clinic - Wisconsin Rapids Center	Wisconsin Rapids	Wisconsin	United States	54494
423	Rocky Mountain Oncology	Casper	Wyoming	United States	82609

Sponsors and Collaborators

Southwest Oncology Group
National Cancer Institute (NCI)

Investigators

Study Chair: Oliver W. Press, MD, PhD, Fred Hutchinson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Southwest Oncology Group

ClinicalTrials.gov Identifier:

NCT00822120

Other Study ID Numbers:

CDR0000630501
S0816
U10CA032102

First Posted:

Jan 14, 2009

Last Update Posted:

Aug 18, 2022

Last Verified:

Aug 1, 2022

Keywords provided by Southwest Oncology Group

stage III adult Hodgkin lymphoma

stage IV adult Hodgkin lymphoma

adult lymphocyte depletion Hodgkin lymphoma

adult lymphocyte predominant Hodgkin lymphoma

adult mixed cellularity Hodgkin lymphoma

adult nodular sclerosis Hodgkin lymphoma

HIV infection

Additional relevant MeSH terms:

Liposomal doxorubicin

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	HIV-negative: Initial ABVD	HIV-positive: Initial ABVD	HIV-negative and PET-negative: Continued ABVD	HIV-negative and PET-positive: BEACOPP Escalated	HIV-positive and PET-negative: Continued ABVD	HIV-positive and PET-positive: BEACOPP Standard
Arm/Group Description	Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles	Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles	Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles	Etoposide 200 mg/m^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m^2 IV Day 1, Cyclophosphamide 1,250 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles	Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles	Etoposide 100 mg/m^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m^2 IV Day 1, Cyclophosphamide 650 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, Q 21 Days x 6 cycles
Period Title: Initial Registration
STARTED	358	13	0	0	0	0
Eligible and Evaluable Patients	336	12	0	0	0	0
COMPLETED	332	12	0	0	0	0
NOT COMPLETED	26	1	0	0	0	0
Period Title: Initial Registration
STARTED	0	0	270	55	10	1
Eligibile and Evaluable Patients	0	0	270	55	10	1
COMPLETED	0	0	270	45	10	1
NOT COMPLETED	0	0	0	10	0	0

Baseline Characteristics

Arm/Group Title	HIV-negative: Initial ABVD	HIV-positive: Initial ABVD	Total
Arm/Group Description	Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles	Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles	Total of all reporting groups
Overall Participants	336	12	348
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	32.1	44.6	32.4
Sex: Female, Male (Count of Participants)
Female	147 43.8%	2 16.7%	149 42.8%
Male	189 56.3%	10 83.3%	199 57.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	28 8.3%	3 25%	31 8.9%
Not Hispanic or Latino	273 81.3%	8 66.7%	281 80.7%
Unknown or Not Reported	35 10.4%	1 8.3%	36 10.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	7 2.1%	0 0%	7 2%
Native Hawaiian or Other Pacific Islander	3 0.9%	0 0%	3 0.9%
Black or African American	32 9.5%	4 33.3%	36 10.3%
White	274 81.5%	5 41.7%	279 80.2%
More than one race	3 0.9%	0 0%	3 0.9%
Unknown or Not Reported	17 5.1%	3 25%	20 5.7%

Outcome Measures

1. Primary Outcome

Title	Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.
Description	Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is > 1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description
Eligible and evaluable HIV-negative patients who started initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.

Arm/Group Title	HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap
Arm/Group Description	HIV-negative patients treated with 2 cycles of ABVD followed by response-adapted therapy. Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-negative patients continue with 4 cycles of ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles. Interim PET-positive patients receive 6 cycles of escalated BEACOPP: Etoposide 200 mg/m^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m^2 IV Day 1, Cyclophosphamide 1,250 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles.
Measure Participants	336
Number (95% Confidence Interval) [percentage of participants]	79 23.5%

2. Primary Outcome

Title	Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS
Description	Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is > 1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description
Eligible and evaluable HIV-negative patients who were PET-positive after 2 cycles of ABVD were included in the analysis.

Arm/Group Title	HIV-negative: 2 Cycles of ABVD Followed by Escalated BEACOPP
Arm/Group Description	HIV-negative patients who are PET-positive are treated with 2 cycles of ABVD followed by escalated BEACOPP. Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-positive patients receive 6 cycles of escalated BEACOPP: Etoposide 200 mg/m^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m^2 IV Day 1, Cyclophosphamide 1,250 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles.
Measure Participants	60
Number (95% Confidence Interval) [percentage of participants]	64 19%

3. Secondary Outcome

Title	Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging
Description	Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description
Eligible and evaluable HIV-negative patients who started initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.

Arm/Group Title	HIV-negative:2 Cycles of ABVD Followed by PET-directed Therapy
Arm/Group Description	HIV-negative patients treated with 2 cycles of ABVD followed by response-adapted therapy. Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-negative patients continue with 4 cycles of ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles. Interim PET-positive patients receive 6 cycles of escalated BEACOPP: Etoposide 200 mg/m^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m^2 IV Day 1, Cyclophosphamide 1,250 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles.
Measure Participants	336
Number (95% Confidence Interval) [percentage of participants]	98 29.2%

4. Secondary Outcome

Title	Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD
Description	Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.
Time Frame	7 months after registration

Outcome Measure Data

Analysis Population Description
Only eligible and evaluable HIV-negative patients who treated with response-adapted therapy based on FDG-PET imaging after 2 cycles of ABVD were included in the analysis

Arm/Group Title	PET-negative: Continued ABVD After 2 Cycles of ABVD	PET-positive: BEACOPP Escalated After 2 Cycles of ABVD
Arm/Group Description	Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles Continued ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles	Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles escalated BEACOPP: Etoposide 200 mg/m^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m^2 IV Day 1, Cyclophosphamide 1,250 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
Measure Participants	270	55
Number (95% Confidence Interval) [percentage of patients]	100	93

5. Secondary Outcome

Title	Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Description	Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description
Eligible HIV-negative patients who had received any treatment were included in the adverse event summaries. Six interim PET-positive patients who did not receive BEACOPP were excluded. patients Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.

Arm/Group Title	HIV-negative: Initial ABVD	HIV-negative and PET-negative: Continued ABVD	HIV-negative and PET-positive: BEACOPP Escalated
Arm/Group Description	Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles	Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles	Etoposide 200 mg/m^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m^2 IV Day 1, Cyclophosphamide 1,250 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
Measure Participants	336	270	49
ALT, SGPT (serum glutamic pyruvic transaminase)	3 0.9%	0 0%	0 0%
AST, SGOT	1 0.3%	0 0%	0 0%
Adult respiratory distress syndrome (ARDS)	0 0%	2 16.7%	0 0%
Albumin, serum-low (hypoalbuminemia)	1 0.3%	0 0%	0 0%
Alkaline phosphatase	1 0.3%	0 0%	0 0%
Allergic reaction/hypersensitivity	2 0.6%	2 16.7%	0 0%
Anorexia	1 0.3%	1 8.3%	0 0%
Arthritis (non-septic)	1 0.3%	0 0%	0 0%
Carbon monoxide diffusion capacity (DL(co))	0 0%	2 16.7%	0 0%
Colitis	0 0%	1 8.3%	0 0%
Colitis, infectious (e.g., Clostridium difficile)	1 0.3%	0 0%	1 0.3%
Constipation	1 0.3%	0 0%	0 0%
Cough	0 0%	1 8.3%	0 0%
Creatinine	0 0%	0 0%	1 0.3%
Cytokine release syndrome/acute infusion reaction	1 0.3%	0 0%	0 0%
Dehydration	1 0.3%	2 16.7%	1 0.3%
Diarrhea	0 0%	1 8.3%	0 0%
Dizziness	1 0.3%	0 0%	1 0.3%
Dyspnea (shortness of breath)	4 1.2%	9 75%	1 0.3%
FEV(1)	0 0%	1 8.3%	0 0%
Fatigue (asthenia, lethargy, malaise)	10 3%	15 125%	3 0.9%
Febrile neutropenia	8 2.4%	17 141.7%	17 4.9%
Fever in absence of neutropenia, ANC lt1.0x10e9/L	0 0%	3 25%	1 0.3%
Glucose, serum-high (hyperglycemia)	0 0%	1 8.3%	1 0.3%
Heartburn/dyspepsia	1 0.3%	0 0%	0 0%
Hemoglobin	10 3%	4 33.3%	37 10.6%
Hemolysis	0 0%	0 0%	1 0.3%
Hemorrhage, pulmonary/upper respiratory - Nose	0 0%	0 0%	1 0.3%
Hypotension	0 0%	0 0%	1 0.3%
Hypoxia	0 0%	3 25%	1 0.3%
Inf (clin/microbio) w/Gr 3-4 neuts - Blood	2 0.6%	1 8.3%	2 0.6%
Inf (clin/microbio) w/Gr 3-4 neuts - Colon	0 0%	0 0%	1 0.3%
Inf (clin/microbio) w/Gr 3-4 neuts - Lung	0 0%	4 33.3%	2 0.6%
Inf (clin/microbio) w/Gr 3-4 neuts - Meninges	1 0.3%	0 0%	0 0%
Inf (clin/microbio) w/Gr 3-4 neuts - Mucosa	1 0.3%	0 0%	0 0%
Inf (clin/microbio) w/Gr 3-4 neuts - Skin	0 0%	1 8.3%	3 0.9%
Inf (clin/microbio) w/Gr 3-4 neuts - Soft tissue	0 0%	1 8.3%	0 0%
Inf (clin/microbio) w/Gr 3-4 neuts - UTI	0 0%	1 8.3%	1 0.3%
Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway	0 0%	1 8.3%	1 0.3%
Inf (clin/microbio) w/Gr 3-4 neuts - Vagina	1 0.3%	0 0%	0 0%
Inf w/normal ANC or Gr 1-2 neutrophils - Catheter	1 0.3%	0 0%	0 0%
Inf w/normal ANC or Gr 1-2 neutrophils - Lung	1 0.3%	3 25%	0 0%
Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav	0 0%	0 0%	1 0.3%
Inf w/normal ANC or Gr 1-2 neutrophils - Skin	1 0.3%	0 0%	1 0.3%
Infection with normal ANC or Grade 1 or 2 neutroph	1 0.3%	0 0%	0 0%
Infection with unknown ANC - Lung (pneumonia)	0 0%	1 8.3%	0 0%
Left ventricular systolic dysfunction	0 0%	1 8.3%	0 0%
Leukocytes (total WBC)	73 21.7%	86 716.7%	42 12.1%
Lymphopenia	15 4.5%	30 250%	32 9.2%
Metabolic/Laboratory-Other (Specify)	1 0.3%	0 0%	0 0%
Mood alteration - agitation	1 0.3%	0 0%	0 0%
Mood alteration - anxiety	1 0.3%	0 0%	0 0%
Mood alteration - depression	1 0.3%	0 0%	0 0%
Mucositis/stomatitis (clinical exam) - Oral cavity	1 0.3%	0 0%	2 0.6%
Mucositis/stomatitis (functional/symp) - Oral cav	1 0.3%	0 0%	1 0.3%
Muscle weakness, not d/t neuropathy - body/general	0 0%	0 0%	1 0.3%
Musculoskeletal/Soft Tissue-Other (Specify)	0 0%	1 8.3%	0 0%
Nausea	7 2.1%	5 41.7%	2 0.6%
Neuropathy: motor	2 0.6%	3 25%	0 0%
Neuropathy: sensory	4 1.2%	12 100%	4 1.1%
Neutrophils/granulocytes (ANC/AGC)	206 61.3%	165 1375%	38 10.9%
Osteonecrosis (avascular necrosis)	0 0%	0 0%	1 0.3%
Pain - Abdomen NOS	2 0.6%	5 41.7%	1 0.3%
Pain - Back	1 0.3%	0 0%	3 0.9%
Pain - Bone	0 0%	0 0%	5 1.4%
Pain - Cardiac/heart	0 0%	1 8.3%	0 0%
Pain - Chest wall	1 0.3%	1 8.3%	0 0%
Pain - Chest/thorax NOS	0 0%	1 8.3%	1 0.3%
Pain - Extremity-limb	1 0.3%	0 0%	0 0%
Pain - Head/headache	2 0.6%	2 16.7%	0 0%
Pain - Joint	1 0.3%	0 0%	1 0.3%
Pain - Muscle	1 0.3%	1 8.3%	0 0%
Pain - Oral cavity	1 0.3%	0 0%	0 0%
Pain - Skin	0 0%	1 8.3%	0 0%
Pain - Stomach	0 0%	1 8.3%	0 0%
Pain - Throat/pharynx/larynx	0 0%	0 0%	1 0.3%
Pain - Tumor pain	1 0.3%	0 0%	0 0%
Pain-Other (Specify)	1 0.3%	2 16.7%	0 0%
Pancreatic endocrine: glucose intolerance	1 0.3%	1 8.3%	0 0%
Phosphate, serum-low (hypophosphatemia)	1 0.3%	0 0%	0 0%
Platelets	1 0.3%	0 0%	34 9.8%
Pneumonitis/pulmonary infiltrates	1 0.3%	4 33.3%	1 0.3%
Potassium, serum-high (hyperkalemia)	0 0%	0 0%	1 0.3%
Potassium, serum-low (hypokalemia)	0 0%	0 0%	4 1.1%
Rash/desquamation	1 0.3%	0 0%	0 0%
Rigors/chills	1 0.3%	0 0%	2 0.6%
Sodium, serum-low (hyponatremia)	1 0.3%	0 0%	1 0.3%
Syncope (fainting)	1 0.3%	0 0%	1 0.3%
Thrombosis/thrombus/embolism	2 0.6%	5 41.7%	0 0%
Vomiting	5 1.5%	4 33.3%	0 0%
Weight gain	0 0%	2 16.7%	0 0%

6. Secondary Outcome

Title	Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.
Description	Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is >1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description
Eligible and evaluable HIV-positive patients who started the initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.

Arm/Group Title	HIV-positive: 2 Cycles of ABVD Followed by PET-directed Therap
Arm/Group Description	HIV-positive patients treated with 2 cycles of ABVD followed by response-adapted therapy. Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-negative patients continue with 4 cycles of ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles. Interim PET-positive patients receive 6 cycles of standard BEACOPP: Etoposide 100 mg/m^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m^2 IV Day 1, Cyclophosphamide 650 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, Q 21 Days x 6 cycles
Measure Participants	12
Number (95% Confidence Interval) [percentage of patients]	83

7. Secondary Outcome

Title	Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging.
Description	Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description
Eligible and evaluable HIV-positive patients who started initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.

Arm/Group Title	HIV-positive: 2 Cycles of ABVD Followed by PET-directed Therap
Arm/Group Description	HIV-positive patients treated with 2 cycles of ABVD followed by response-adapted therapy. Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-negative patients continue with 4 cycles of ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles. Interim PET-positive patients receive 6 cycles of standard BEACOPP: Etoposide 100 mg/m^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m^2 IV Day 1, Cyclophosphamide 650 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, Q 21 Days x 6 cycles
Measure Participants	12
Number (95% Confidence Interval) [percentage of participants]	89 26.5%

8. Secondary Outcome

Title	Complete and Partial Response Rates for HIV-positive Patients Treated With Response-Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD
Description	Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.
Time Frame	7 months after registration

Outcome Measure Data

Analysis Population Description
Eligible and evaluable HIV-positive patients who treated with 2 initial cycles of ABVD followed by response-adapted therapy based on interim FDG-PET imaging were included he analysis.

Arm/Group Title	PET-negative: Continued ABVD After 2 Cycles of ABVD	PET-positive: BEACOPP Standard After 2 Cycles of ABVD
Arm/Group Description	Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles Continued ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles	Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles standard BEACOPP: Etoposide 100 mg/m^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m^2 IV Day 1, Cyclophosphamide 650 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, Q 21 Days x 6 cycles
Measure Participants	10	1
Complete Response	9 2.7%	0 0%
Partial Response	1 0.3%	1 8.3%

9. Secondary Outcome

Title	Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Description	Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description
Eligible HIV-positive patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.

Arm/Group Title	Initial ABVD	PET-negative: Continued ABVD	PET-positive: BEACOPP Standard
Arm/Group Description	Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles	Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles	Etoposide 100 mg/m^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m^2 IV Day 1, Cyclophosphamide 650 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, Q 21 Days x 6 cycles
Measure Participants	12	10	1
Anorexia	0 0%	1 8.3%	0 0%
Dizziness	0 0%	1 8.3%	0 0%
Fatigue (asthenia, lethargy, malaise)	1 0.3%	1 8.3%	0 0%
Febrile neutropenia	3 0.9%	3 25%	0 0%
Hemoglobin	1 0.3%	3 25%	1 0.3%
Inf (clin/microbio) w/Gr 3-4 neuts - Eye NOS	1 0.3%	0 0%	0 0%
Inf (clin/microbio) w/Gr 3-4 neuts - Lung	0 0%	1 8.3%	0 0%
Infection with unknown ANC - Urinary tract NOS	0 0%	0 0%	1 0.3%
Insomnia	1 0.3%	0 0%	0 0%
Leukocytes (total WBC)	7 2.1%	6 50%	1 0.3%
Lymphopenia	1 0.3%	2 16.7%	1 0.3%
Mood alteration - agitation	1 0.3%	0 0%	0 0%
Mood alteration - anxiety	1 0.3%	0 0%	0 0%
Muscle weakness, not d/t neuropathy - body/general	1 0.3%	0 0%	0 0%
Neuropathy: motor	0 0%	1 8.3%	0 0%
Neuropathy: sensory	1 0.3%	1 8.3%	0 0%
Neutrophils/granulocytes (ANC/AGC)	8 2.4%	7 58.3%	1 0.3%
Pain - Bone	1 0.3%	0 0%	0 0%
Pain - Joint	1 0.3%	1 8.3%	0 0%
Phosphate, serum-low (hypophosphatemia)	1 0.3%	1 8.3%	0 0%
Platelets	0 0%	1 8.3%	0 0%
Sodium, serum-low (hyponatremia)	1 0.3%	0 0%	0 0%
Thrombosis/thrombus/embolism	0 0%	1 8.3%	0 0%

Adverse Events

	HIV-negative: Initial ABVD		HIV-negative and PET-negative: Continued ABVD		HIV-negative and PET-positive: BEACOPP Escalated		HIV-positive: Initial ABVD		HIV-positive and PET-negative: Continued ABVD		HIV-positive and PET-positive: BEACOPP Standard
Time Frame	Up to 1 year
Adverse Event Reporting Description

Arm/Group Title	HIV-negative: Initial ABVD		HIV-negative and PET-negative: Continued ABVD		HIV-negative and PET-positive: BEACOPP Escalated		HIV-positive: Initial ABVD		HIV-positive and PET-negative: Continued ABVD		HIV-positive and PET-positive: BEACOPP Standard
Arm/Group Description	Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles		Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles		Etoposide 200 mg/m^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m^2 IV Day 1, Cyclophosphamide 1,250 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles		Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles		Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles		Etoposide 100 mg/m^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m^2 IV Day 1, Cyclophosphamide 650 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, Q 21 Days x 6 cycles
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	HIV-negative: Initial ABVD		HIV-negative and PET-negative: Continued ABVD		HIV-negative and PET-positive: BEACOPP Escalated		HIV-positive: Initial ABVD		HIV-positive and PET-negative: Continued ABVD		HIV-positive and PET-positive: BEACOPP Standard
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/336 (0.3%)		6/270 (2.2%)		2/49 (4.1%)		1/12 (8.3%)		0/10 (0%)		0/1 (0%)
Blood and lymphatic system disorders
Febrile neutropenia	0/336 (0%)		0/270 (0%)		1/49 (2%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Hemoglobin	0/336 (0%)		1/270 (0.4%)		0/49 (0%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Gastrointestinal disorders
Colitis	0/336 (0%)		1/270 (0.4%)		0/49 (0%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Blood	0/336 (0%)		0/270 (0%)		1/49 (2%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Infection with unknown ANC - Lung (pneumonia)	0/336 (0%)		1/270 (0.4%)		0/49 (0%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Investigations
Leukocytes (total WBC)	0/336 (0%)		0/270 (0%)		0/49 (0%)		1/12 (8.3%)		0/10 (0%)		0/1 (0%)
Neutrophils/granulocytes (ANC/AGC)	0/336 (0%)		1/270 (0.4%)		0/49 (0%)		1/12 (8.3%)		0/10 (0%)		0/1 (0%)
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)	0/336 (0%)		0/270 (0%)		0/49 (0%)		1/12 (8.3%)		0/10 (0%)		0/1 (0%)
Psychiatric disorders
Mood alteration - agitation	1/336 (0.3%)		0/270 (0%)		0/49 (0%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Mood alteration - depression	1/336 (0.3%)		0/270 (0%)		0/49 (0%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)	0/336 (0%)		0/270 (0%)		1/49 (2%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Pneumonitis/pulmonary infiltrates	0/336 (0%)		1/270 (0.4%)		1/49 (2%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Vascular disorders
Thrombosis/thrombus/embolism	0/336 (0%)		2/270 (0.7%)		0/49 (0%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	HIV-negative: Initial ABVD		HIV-negative and PET-negative: Continued ABVD		HIV-negative and PET-positive: BEACOPP Escalated		HIV-positive: Initial ABVD		HIV-positive and PET-negative: Continued ABVD		HIV-positive and PET-positive: BEACOPP Standard
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	335/336 (99.7%)		268/270 (99.3%)		49/49 (100%)		12/12 (100%)		9/10 (90%)		1/1 (100%)
Blood and lymphatic system disorders
Febrile neutropenia	8/336 (2.4%)		17/270 (6.3%)		16/49 (32.7%)		3/12 (25%)		3/10 (30%)		0/1 (0%)
Hemoglobin	171/336 (50.9%)		161/270 (59.6%)		44/49 (89.8%)		6/12 (50%)		7/10 (70%)		1/1 (100%)
Cardiac disorders
Palpitations	2/336 (0.6%)		4/270 (1.5%)		3/49 (6.1%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
SVT and nodal arrhythmia - Sinus tachycardia	7/336 (2.1%)		9/270 (3.3%)		3/49 (6.1%)		1/12 (8.3%)		1/10 (10%)		0/1 (0%)
Eye disorders
Ocular/Visual-Other	10/336 (3%)		15/270 (5.6%)		2/49 (4.1%)		0/12 (0%)		0/10 (0%)		1/1 (100%)
Gastrointestinal disorders
Constipation	114/336 (33.9%)		73/270 (27%)		10/49 (20.4%)		5/12 (41.7%)		2/10 (20%)		0/1 (0%)
Dental: teeth	1/336 (0.3%)		1/270 (0.4%)		0/49 (0%)		1/12 (8.3%)		0/10 (0%)		0/1 (0%)
Diarrhea	34/336 (10.1%)		40/270 (14.8%)		15/49 (30.6%)		3/12 (25%)		5/10 (50%)		0/1 (0%)
Dysphagia (difficulty swallowing)	2/336 (0.6%)		2/270 (0.7%)		3/49 (6.1%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Flatulence	4/336 (1.2%)		4/270 (1.5%)		3/49 (6.1%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Gastritis (including bile reflux gastritis)	4/336 (1.2%)		1/270 (0.4%)		0/49 (0%)		1/12 (8.3%)		0/10 (0%)		0/1 (0%)
Heartburn/dyspepsia	28/336 (8.3%)		30/270 (11.1%)		5/49 (10.2%)		0/12 (0%)		1/10 (10%)		0/1 (0%)
Mucositis/stomatitis (clinical exam) - Oral cavity	36/336 (10.7%)		25/270 (9.3%)		13/49 (26.5%)		2/12 (16.7%)		1/10 (10%)		1/1 (100%)
Mucositis/stomatitis (functional/symp) - Oral cav	27/336 (8%)		12/270 (4.4%)		2/49 (4.1%)		1/12 (8.3%)		0/10 (0%)		0/1 (0%)
Nausea	203/336 (60.4%)		173/270 (64.1%)		29/49 (59.2%)		4/12 (33.3%)		6/10 (60%)		0/1 (0%)
Pain - Abdomen NOS	32/336 (9.5%)		28/270 (10.4%)		4/49 (8.2%)		1/12 (8.3%)		1/10 (10%)		0/1 (0%)
Pain - Oral cavity	14/336 (4.2%)		4/270 (1.5%)		5/49 (10.2%)		0/12 (0%)		1/10 (10%)		0/1 (0%)
Vomiting	68/336 (20.2%)		74/270 (27.4%)		19/49 (38.8%)		3/12 (25%)		4/10 (40%)		0/1 (0%)
General disorders
Edema: limb	13/336 (3.9%)		21/270 (7.8%)		12/49 (24.5%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Fatigue (asthenia, lethargy, malaise)	203/336 (60.4%)		191/270 (70.7%)		36/49 (73.5%)		5/12 (41.7%)		7/10 (70%)		1/1 (100%)
Fever in absence of neutropenia, ANC lt1.0x10e9/L	24/336 (7.1%)		35/270 (13%)		10/49 (20.4%)		1/12 (8.3%)		3/10 (30%)		1/1 (100%)
Pain - Chest/thorax NOS	17/336 (5.1%)		15/270 (5.6%)		7/49 (14.3%)		0/12 (0%)		1/10 (10%)		0/1 (0%)
Pain-Other	24/336 (7.1%)		29/270 (10.7%)		7/49 (14.3%)		0/12 (0%)		1/10 (10%)		0/1 (0%)
Rigors/chills	20/336 (6%)		17/270 (6.3%)		11/49 (22.4%)		2/12 (16.7%)		4/10 (40%)		1/1 (100%)
Syndromes-Other	0/336 (0%)		1/270 (0.4%)		0/49 (0%)		1/12 (8.3%)		0/10 (0%)		0/1 (0%)
Immune system disorders
Allergic reaction/hypersensitivity	5/336 (1.5%)		6/270 (2.2%)		4/49 (8.2%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Cytokine release syndrome/acute infusion reaction	2/336 (0.6%)		0/270 (0%)		0/49 (0%)		1/12 (8.3%)		0/10 (0%)		0/1 (0%)
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)	1/336 (0.3%)		0/270 (0%)		1/49 (2%)		1/12 (8.3%)		1/10 (10%)		0/1 (0%)
Inf (clin/microbio) w/Gr 3-4 neuts - Eye NOS	0/336 (0%)		0/270 (0%)		0/49 (0%)		1/12 (8.3%)		0/10 (0%)		0/1 (0%)
Inf (clin/microbio) w/Gr 3-4 neuts - Lung	1/336 (0.3%)		4/270 (1.5%)		3/49 (6.1%)		0/12 (0%)		1/10 (10%)		0/1 (0%)
Inf (clin/microbio) w/Gr 3-4 neuts - Skin	1/336 (0.3%)		4/270 (1.5%)		3/49 (6.1%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Infection with unknown ANC - Ureter	0/336 (0%)		0/270 (0%)		0/49 (0%)		0/12 (0%)		1/10 (10%)		0/1 (0%)
Infection with unknown ANC - Urinary tract NOS	1/336 (0.3%)		1/270 (0.4%)		0/49 (0%)		0/12 (0%)		0/10 (0%)		1/1 (100%)
Infection-Other	6/336 (1.8%)		14/270 (5.2%)		4/49 (8.2%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Injury, poisoning and procedural complications
Bruising (in absence of Gr 3-4 thrombocytopenia)	2/336 (0.6%)		3/270 (1.1%)		1/49 (2%)		1/12 (8.3%)		0/10 (0%)		0/1 (0%)
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)	68/336 (20.2%)		49/270 (18.1%)		13/49 (26.5%)		2/12 (16.7%)		4/10 (40%)		0/1 (0%)
AST, SGOT	55/336 (16.4%)		41/270 (15.2%)		9/49 (18.4%)		2/12 (16.7%)		4/10 (40%)		0/1 (0%)
Alkaline phosphatase	38/336 (11.3%)		14/270 (5.2%)		7/49 (14.3%)		2/12 (16.7%)		3/10 (30%)		0/1 (0%)
Bilirubin (hyperbilirubinemia)	3/336 (0.9%)		4/270 (1.5%)		2/49 (4.1%)		1/12 (8.3%)		0/10 (0%)		0/1 (0%)
CD4 count	0/336 (0%)		0/270 (0%)		0/49 (0%)		0/12 (0%)		1/10 (10%)		0/1 (0%)
Carbon monoxide diffusion capacity (DL(co))	0/336 (0%)		7/270 (2.6%)		0/49 (0%)		0/12 (0%)		1/10 (10%)		0/1 (0%)
Creatinine	12/336 (3.6%)		9/270 (3.3%)		5/49 (10.2%)		2/12 (16.7%)		2/10 (20%)		1/1 (100%)
Leukocytes (total WBC)	212/336 (63.1%)		188/270 (69.6%)		45/49 (91.8%)		7/12 (58.3%)		6/10 (60%)		1/1 (100%)
Lipase	0/336 (0%)		0/270 (0%)		0/49 (0%)		1/12 (8.3%)		1/10 (10%)		0/1 (0%)
Lymphopenia	80/336 (23.8%)		94/270 (34.8%)		32/49 (65.3%)		4/12 (33.3%)		6/10 (60%)		1/1 (100%)
Metabolic/Laboratory-Other	11/336 (3.3%)		7/270 (2.6%)		5/49 (10.2%)		0/12 (0%)		1/10 (10%)		0/1 (0%)
Neutrophils/granulocytes (ANC/AGC)	250/336 (74.4%)		213/270 (78.9%)		41/49 (83.7%)		9/12 (75%)		7/10 (70%)		1/1 (100%)
PTT (Partial thromboplastin time)	3/336 (0.9%)		1/270 (0.4%)		3/49 (6.1%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Platelets	19/336 (5.7%)		23/270 (8.5%)		44/49 (89.8%)		2/12 (16.7%)		3/10 (30%)		1/1 (100%)
Weight gain	18/336 (5.4%)		26/270 (9.6%)		2/49 (4.1%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Weight loss	11/336 (3.3%)		12/270 (4.4%)		1/49 (2%)		1/12 (8.3%)		1/10 (10%)		0/1 (0%)
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)	36/336 (10.7%)		35/270 (13%)		13/49 (26.5%)		0/12 (0%)		1/10 (10%)		0/1 (0%)
Anorexia	42/336 (12.5%)		47/270 (17.4%)		13/49 (26.5%)		3/12 (25%)		3/10 (30%)		0/1 (0%)
Bicarbonate, serum-low	0/336 (0%)		0/270 (0%)		0/49 (0%)		0/12 (0%)		1/10 (10%)		0/1 (0%)
Calcium, serum-low (hypocalcemia)	30/336 (8.9%)		32/270 (11.9%)		16/49 (32.7%)		2/12 (16.7%)		3/10 (30%)		1/1 (100%)
Dehydration	6/336 (1.8%)		10/270 (3.7%)		5/49 (10.2%)		1/12 (8.3%)		0/10 (0%)		0/1 (0%)
Glucose, serum-high (hyperglycemia)	69/336 (20.5%)		82/270 (30.4%)		23/49 (46.9%)		4/12 (33.3%)		5/10 (50%)		0/1 (0%)
Glucose, serum-low (hypoglycemia)	6/336 (1.8%)		9/270 (3.3%)		5/49 (10.2%)		2/12 (16.7%)		1/10 (10%)		0/1 (0%)
Magnesium, serum-low (hypomagnesemia)	5/336 (1.5%)		2/270 (0.7%)		4/49 (8.2%)		0/12 (0%)		1/10 (10%)		0/1 (0%)
Phosphate, serum-low (hypophosphatemia)	2/336 (0.6%)		5/270 (1.9%)		5/49 (10.2%)		1/12 (8.3%)		1/10 (10%)		0/1 (0%)
Potassium, serum-high (hyperkalemia)	6/336 (1.8%)		7/270 (2.6%)		5/49 (10.2%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Potassium, serum-low (hypokalemia)	12/336 (3.6%)		19/270 (7%)		22/49 (44.9%)		1/12 (8.3%)		3/10 (30%)		0/1 (0%)
Sodium, serum-low (hyponatremia)	19/336 (5.7%)		18/270 (6.7%)		10/49 (20.4%)		1/12 (8.3%)		2/10 (20%)		0/1 (0%)
Uric acid, serum-high (hyperuricemia)	1/336 (0.3%)		0/270 (0%)		4/49 (8.2%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general	4/336 (1.2%)		7/270 (2.6%)		6/49 (12.2%)		2/12 (16.7%)		1/10 (10%)		0/1 (0%)
Pain - Back	27/336 (8%)		24/270 (8.9%)		9/49 (18.4%)		1/12 (8.3%)		2/10 (20%)		0/1 (0%)
Pain - Bone	19/336 (5.7%)		22/270 (8.1%)		22/49 (44.9%)		3/12 (25%)		2/10 (20%)		0/1 (0%)
Pain - Chest wall	7/336 (2.1%)		6/270 (2.2%)		3/49 (6.1%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Pain - Extremity-limb	18/336 (5.4%)		21/270 (7.8%)		6/49 (12.2%)		0/12 (0%)		2/10 (20%)		0/1 (0%)
Pain - Joint	31/336 (9.2%)		30/270 (11.1%)		12/49 (24.5%)		2/12 (16.7%)		2/10 (20%)		1/1 (100%)
Pain - Muscle	39/336 (11.6%)		45/270 (16.7%)		9/49 (18.4%)		2/12 (16.7%)		2/10 (20%)		0/1 (0%)
Nervous system disorders
Dizziness	30/336 (8.9%)		25/270 (9.3%)		12/49 (24.5%)		2/12 (16.7%)		1/10 (10%)		0/1 (0%)
Neuropathy: motor	9/336 (2.7%)		14/270 (5.2%)		1/49 (2%)		2/12 (16.7%)		2/10 (20%)		0/1 (0%)
Neuropathy: sensory	85/336 (25.3%)		103/270 (38.1%)		31/49 (63.3%)		6/12 (50%)		5/10 (50%)		1/1 (100%)
Ocular/Visual-Other	10/336 (3%)		15/270 (5.6%)		2/49 (4.1%)		0/12 (0%)		0/10 (0%)		1/1 (100%)
Pain - Head/headache	47/336 (14%)		40/270 (14.8%)		12/49 (24.5%)		4/12 (33.3%)		2/10 (20%)		0/1 (0%)
Taste alteration (dysgeusia)	38/336 (11.3%)		35/270 (13%)		8/49 (16.3%)		0/12 (0%)		1/10 (10%)		0/1 (0%)
Psychiatric disorders
Confusion	0/336 (0%)		0/270 (0%)		0/49 (0%)		1/12 (8.3%)		0/10 (0%)		0/1 (0%)
Insomnia	44/336 (13.1%)		48/270 (17.8%)		12/49 (24.5%)		1/12 (8.3%)		0/10 (0%)		0/1 (0%)
Libido	0/336 (0%)		0/270 (0%)		0/49 (0%)		1/12 (8.3%)		1/10 (10%)		0/1 (0%)
Mood alteration - agitation	1/336 (0.3%)		2/270 (0.7%)		1/49 (2%)		1/12 (8.3%)		0/10 (0%)		0/1 (0%)
Mood alteration - anxiety	21/336 (6.3%)		25/270 (9.3%)		8/49 (16.3%)		1/12 (8.3%)		1/10 (10%)		0/1 (0%)
Mood alteration - depression	11/336 (3.3%)		14/270 (5.2%)		5/49 (10.2%)		0/12 (0%)		1/10 (10%)		0/1 (0%)
Renal and urinary disorders
Hemorrhage, GU - Urinary NOS	2/336 (0.6%)		1/270 (0.4%)		1/49 (2%)		0/12 (0%)		1/10 (10%)		0/1 (0%)
Pain - Urethra	1/336 (0.3%)		1/270 (0.4%)		1/49 (2%)		0/12 (0%)		1/10 (10%)		0/1 (0%)
Urinary frequency/urgency	5/336 (1.5%)		6/270 (2.2%)		4/49 (8.2%)		1/12 (8.3%)		0/10 (0%)		0/1 (0%)
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis	12/336 (3.6%)		24/270 (8.9%)		3/49 (6.1%)		0/12 (0%)		1/10 (10%)		1/1 (100%)
Carbon monoxide diffusion capacity (DL(co))	0/336 (0%)		7/270 (2.6%)		0/49 (0%)		0/12 (0%)		1/10 (10%)		0/1 (0%)
Cough	44/336 (13.1%)		72/270 (26.7%)		13/49 (26.5%)		0/12 (0%)		3/10 (30%)		1/1 (100%)
Dyspnea (shortness of breath)	56/336 (16.7%)		70/270 (25.9%)		17/49 (34.7%)		1/12 (8.3%)		2/10 (20%)		0/1 (0%)
Hemorrhage, pulmonary/upper respiratory - Nose	2/336 (0.6%)		2/270 (0.7%)		5/49 (10.2%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Pain - Throat/pharynx/larynx	19/336 (5.7%)		17/270 (6.3%)		4/49 (8.2%)		0/12 (0%)		2/10 (20%)		0/1 (0%)
Pneumonitis/pulmonary infiltrates	3/336 (0.9%)		12/270 (4.4%)		3/49 (6.1%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Pulmonary/Upper Respiratory-Other	5/336 (1.5%)		16/270 (5.9%)		2/49 (4.1%)		0/12 (0%)		2/10 (20%)		1/1 (100%)
Voice changes/dysarthria	2/336 (0.6%)		2/270 (0.7%)		3/49 (6.1%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other	14/336 (4.2%)		15/270 (5.6%)		3/49 (6.1%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Hair loss/Alopecia (scalp or body)	80/336 (23.8%)		97/270 (35.9%)		16/49 (32.7%)		2/12 (16.7%)		3/10 (30%)		1/1 (100%)
Hyperpigmentation	11/336 (3.3%)		18/270 (6.7%)		2/49 (4.1%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Nail changes	9/336 (2.7%)		32/270 (11.9%)		4/49 (8.2%)		1/12 (8.3%)		2/10 (20%)		0/1 (0%)
Pruritus/itching	21/336 (6.3%)		20/270 (7.4%)		2/49 (4.1%)		2/12 (16.7%)		1/10 (10%)		0/1 (0%)
Rash/desquamation	41/336 (12.2%)		48/270 (17.8%)		9/49 (18.4%)		1/12 (8.3%)		1/10 (10%)		0/1 (0%)
Rash: acne/acneiform	6/336 (1.8%)		9/270 (3.3%)		3/49 (6.1%)		0/12 (0%)		0/10 (0%)		0/1 (0%)
Sweating (diaphoresis)	31/336 (9.2%)		33/270 (12.2%)		12/49 (24.5%)		2/12 (16.7%)		0/10 (0%)		1/1 (100%)
Vascular disorders
Hot flashes/flushes	7/336 (2.1%)		17/270 (6.3%)		7/49 (14.3%)		1/12 (8.3%)		1/10 (10%)		0/1 (0%)
Hypertension	4/336 (1.2%)		6/270 (2.2%)		2/49 (4.1%)		1/12 (8.3%)		2/10 (20%)		0/1 (0%)
Hypotension	6/336 (1.8%)		5/270 (1.9%)		2/49 (4.1%)		1/12 (8.3%)		1/10 (10%)		0/1 (0%)
Phlebitis (including superficial thrombosis)	5/336 (1.5%)		9/270 (3.3%)		2/49 (4.1%)		1/12 (8.3%)		0/10 (0%)		0/1 (0%)
Thrombosis/thrombus/embolism	6/336 (1.8%)		8/270 (3%)		2/49 (4.1%)		0/12 (0%)		1/10 (10%)		0/1 (0%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title	Lymphoma Committee Statistician
Organization	SWOG Statistical Center
Phone	206-667-4623
Email

Responsible Party:

Southwest Oncology Group

ClinicalTrials.gov Identifier:

NCT00822120

Other Study ID Numbers:

CDR0000630501
S0816
U10CA032102

First Posted:

Jan 14, 2009

Last Update Posted:

Aug 18, 2022

Last Verified:

Aug 1, 2022

S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma

Study Details

Study Description

Brief Summary

Detailed Description

OBJECTIVES:

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS:

PRIOR CONCURRENT THERAPY:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

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Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

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Results Point of Contact