S0117 Gemtuzumab Ozogamicin Plus Cytarabine in Treating Patients With Relapsed Acute Myeloid Leukemia

Sponsor

Southwest Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00049179

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

151

Locations

Duration (Months)

0.2

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy such as cytarabine use different ways to stop cancer cells from dividing so they stop growing or die. Combining gemtuzumab ozogamicin with cytarabine may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemtuzumab ozogamicin with cytarabine in treating patients who have relapsed acute myeloid leukemia.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Drug: cytarabine Drug: gemtuzumab ozogamicin	Phase 2

Detailed Description

OBJECTIVES:

Determine the safety and efficacy of gemtuzumab ozogamicin and cytarabine in patients with relapsed acute myeloid leukemia.
Determine the frequency and severity of toxic effects of this regimen in CD33-positive patients.
Determine, preliminarily, the prognostic significance of drug resistance phenotype, cytogenetics, and molecular genetic characteristics of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Induction: Patients receive gemtuzumab ozogamicin IV over at least 2 hours on days 1 and 8 and cytarabine IV continuously over days 1-7.
Consolidation: Beginning between days 28 and 75, patients who achieve A1 bone marrow, B1 peripheral blood, and C1 extramedullary disease status receive one course of gemtuzumab ozogamicin and cisplatin as in induction chemotherapy.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study within 10-28 months.

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Gemtuzumab Ozogamicin (Mylotarg) and Standard Dose ARA-C for Patients With Relapsed Acute Myeloid Leukemia (AML)

Study Start Date :

Apr 1, 2003

Actual Primary Completion Date :

Dec 1, 2005

Actual Study Completion Date :

Oct 1, 2010

Outcome Measures

Primary Outcome Measures

CR [After induction therapy is completed]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed acute myeloid leukemia (AML)
FAB M1-2 or M4-7
No blastic transformation of chronic myelogenous leukemia
In first relapse after prior complete response
Patients who relapsed after autologous or allogeneic bone marrow or peripheral blood stem cell transplantation are not eligible
CD33 positive
Prior myelodysplastic syndromes or secondary AML allowed
Concurrent enrollment on SWOG-9007 (cytogenetics protocol)
No clinical or documented CNS involvement with AML

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Zubrod 0-2

Life expectancy

Not specified

Hematopoietic

WBC no greater than 30,000/mm^3

Hepatic

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST or ALT no greater than 1.5 times ULN

Renal

Not specified

Cardiovascular

No unstable cardiac arrhythmias
No unstable angina

Other

HIV negative
No other malignancy within the past 5 years except for the following:
Adequately treated basal cell or squamous cell skin cancer
Carcinoma in situ of the cervix
Adequately treated stage I or II cancer currently in complete remission
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

See Disease Characteristics
No prior gemtuzumab ozogamicin for AML

Chemotherapy

Prior hydroxyurea to control high cell counts allowed

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Other

At least 4 weeks since prior investigational agents and recovered

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alta Bates Comprehensive Cancer Center	Berkeley	California	United States	94705
2	Mills-Peninsula Health Services	Burlingame	California	United States	94010
3	Marin Cancer Institute at Marin General Hospital	Greenbrae	California	United States	94904
4	Sutter Health Western Division Cancer Research Group	Greenbrae	California	United States	94904
5	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center	Orange	California	United States	92868
6	California Pacific Medical Center - California Campus	San Francisco	California	United States	94118
7	Phoebe Cancer Center at Phoebe Putney Memorial Hospital	Albany	Georgia	United States	31703
8	Piedmont Hospital	Atlanta	Georgia	United States	30309
9	CCOP - Atlanta Regional	Atlanta	Georgia	United States	30342
10	Northside Hospital Cancer Center	Atlanta	Georgia	United States	30342
11	Saint Joseph's Hospital of Atlanta	Atlanta	Georgia	United States	30342
12	WellStar Cobb Hospital	Austell	Georgia	United States	30106
13	Charles B. Eberhart Cancer Center at DeKalb Medical Center	Decatur	Georgia	United States	30033
14	Gwinnett Medical Center	Lawrenceville	Georgia	United States	30045
15	Kennestone Cancer Center at Wellstar Kennestone Hospital	Marietta	Georgia	United States	30060
16	Southern Regional Medical Center	Riverdale	Georgia	United States	30274
17	Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia	United States	31403
18	Hematology Oncology Associates of Eastern Idaho	Idaho Falls	Idaho	United States	83404
19	Saint Anthony's Hospital at Saint Anthony's Health Center	Alton	Illinois	United States	62002
20	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois	United States	62526
21	Veterans Affairs Medical Center - Hines	Hines	Illinois	United States	60141
22	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois	United States	60153
23	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois	United States	62781-0001
24	St. Francis Hospital and Health Centers	Beech Grove	Indiana	United States	46107
25	Cancer Center of Kansas - Chanute	Chanute	Kansas	United States	66720
26	Cancer Center of Kansas - Dodge City	Dodge City	Kansas	United States	67801
27	Cancer Center of Kansas, P.A. - El Dorado	El Dorado	Kansas	United States	67042
28	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas	United States	66160
29	Cancer Center of Kansas - Kingman	Kingman	Kansas	United States	67068
30	Southwest Medical Center	Liberal	Kansas	United States	67901
31	Cancer Center of Kansas - Newton	Newton	Kansas	United States	67114
32	Cancer Center of Kansas, P.A. - Parsons	Parsons	Kansas	United States	67357
33	Pratt Cancer Center of Kansas	Pratt	Kansas	United States	67124
34	Cancer Center of Kansas - Salina	Salina	Kansas	United States	67042
35	Salina Regional Health Center	Salina	Kansas	United States	67401
36	Cancer Center at Stormont-Vail Regional Health Center	Topeka	Kansas	United States	66604
37	St. Francis Comprehensive Cancer Center	Topeka	Kansas	United States	66606
38	Cancer Center of Kansas - Wellington	Wellington	Kansas	United States	67152
39	Associates in Womens Health	Wichita	Kansas	United States	67203
40	Cancer Center of Kansas, P.A.	Wichita	Kansas	United States	67208
41	Cancer Center of Kansas, P.A. - Wichita	Wichita	Kansas	United States	67214
42	CCOP - Wichita	Wichita	Kansas	United States	67214
43	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
44	Wesley Medical Center	Wichita	Kansas	United States	67214
45	Cancer Center of Kansas - Winfield	Winfield	Kansas	United States	67156
46	Baton Rouge General Regional Cancer Center	Baton Rouge	Louisiana	United States	70806
47	Mary Bird Perkins Cancer Center - Baton Rouge	Baton Rouge	Louisiana	United States	70809
48	Louisiana State University Health Sciences Center - Monroe	Monroe	Louisiana	United States	71210
49	Cancer Center at Medical Center of Louisiana - New Orleans	New Orleans	Louisiana	United States	70112
50	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
51	Tulane Cancer Center	New Orleans	Louisiana	United States	70112
52	Veterans Affairs Medical Center - Shreveport	Shreveport	Louisiana	United States	71101
53	Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Shreveport	Louisiana	United States	71130
54	Providence Cancer Institute at Providence Hospital - Southfield Campus	Southfield	Michigan	United States	48075
55	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
56	St. Francis Medical Center	Cape Girardeau	Missouri	United States	63701
57	Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital	Gape Girardeau	Missouri	United States	63701
58	CCOP - Kansas City	Kansas City	Missouri	United States	64131
59	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65802
60	St. John's Regional Health Center	Springfield	Missouri	United States	65804
61	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri	United States	65807
62	CCOP - St. Louis-Cape Girardeau	St. Louis	Missouri	United States	63141
63	David C. Pratt Cancer Center at St. John's Mercy	St. Louis	Missouri	United States	63141
64	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
65	Deaconess Billings Clinic - Downtown	Billings	Montana	United States	59101
66	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59101
67	Northern Rockies Radiation Oncology Center	Billings	Montana	United States	59101
68	St. Vincent Healthcare	Billings	Montana	United States	59101
69	Deaconess Billings Clinic Cancer Center	Billings	Montana	United States	59107
70	Bozeman Deaconess Hospital	Bozeman	Montana	United States	59715
71	Internal Medicine Associates of Bozeman	Bozeman	Montana	United States	59715
72	St. James Community Hospital	Butte	Montana	United States	59701
73	Big Sky Oncology	Great Falls	Montana	United States	59405
74	Great Falls Clinic	Great Falls	Montana	United States	59405
75	Sletten Regional Cancer Institute	Great Falls	Montana	United States	59405
76	St. Peter's Hospital	Helena	Montana	United States	59601
77	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
78	Kalispell Medical Oncology	Kalispell	Montana	United States	59901
79	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
80	Eastern Montana Cancer Center	Miles City	Montana	United States	59301
81	Community Medical Center	Missoula	Montana	United States	59801
82	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59802
83	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59802
84	Orange Regional Medical Center - Horton Campus	Middletown	New York	United States	10940
85	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York	United States	14642
86	Randolph Hospital	Asheboro	North Carolina	United States	27203
87	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina	United States	28233
88	John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital	Eden	North Carolina	United States	27288
89	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
90	Moses Cone Regional Cancer Center at Wesley Long Community Hospital	Greensboro	North Carolina	United States	27401
91	Annie Penn Cancer Center	Reidsville	North Carolina	United States	27320
92	Rutherford Hospital	Rutherfordton	North Carolina	United States	28139
93	Adena Regional Medical Center	Chillicothe	Ohio	United States	54601
94	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
95	Riverside Methodist Hospital Cancer Care	Columbus	Ohio	United States	43214
96	CCOP - Columbus	Columbus	Ohio	United States	43215
97	Grant Riverside Cancer Services	Columbus	Ohio	United States	43215
98	Mount Carmel West Hospital	Columbus	Ohio	United States	43222
99	Doctors Hospital at Ohio Health	Columbus	Ohio	United States	43228
100	Grandview Hospital	Dayton	Ohio	United States	45405
101	Good Samaritan Hospital	Dayton	Ohio	United States	45406
102	Miami Valley Hospital	Dayton	Ohio	United States	45409
103	Samaritan North Cancer Care Center	Dayton	Ohio	United States	45415
104	Veterans Affairs Medical Center - Dayton	Dayton	Ohio	United States	45428
105	CCOP - Dayton	Dayton	Ohio	United States	45429
106	Grady Memorial Hospital	Delaware	Ohio	United States	43015
107	Community Oncology Group - Independence	Independence	Ohio	United States	44131
108	Charles F. Kettering Memorial Hospital	Kettering	Ohio	United States	45429
109	Fairfield Medical Center	Lancaster	Ohio	United States	43130
110	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio	United States	45750
111	Middletown Regional Hospital	Middletown	Ohio	United States	45044
112	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio	United States	43055
113	Mercy Medical Center Oncology Unit	Springfield	Ohio	United States	45504
114	Community Hospital of Springfield and Clark County	Springfield	Ohio	United States	45505
115	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio	United States	45373
116	Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital	Westerville	Ohio	United States	43081
117	Cleveland Clinic - Wooster	Wooster	Ohio	United States	44691
118	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio	United States	45385
119	Tod Children's Hospital - Forum Health	Youngstown	Ohio	United States	44501
120	Genesis - Good Samaritan Hospital	Zanesville	Ohio	United States	43701
121	Legacy Mount Hood Medical Center	Glesham	Oregon	United States	97030
122	Providence Milwaukie Hospital	Milwaukie	Oregon	United States	97222
123	Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center	Portland	Oregon	United States	97210
124	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon	United States	97213
125	CCOP - Columbia River Oncology Program	Portland	Oregon	United States	97225
126	Providence St. Vincent Medical Center	Portland	Oregon	United States	97225
127	Institute of Oncology at Vilnius University	Portland	Oregon	United States	97227
128	Legacy Meridian Park Hospital	Tualatin	Oregon	United States	97062
129	Rose Ramer Cancer Clinic at Anderson Area Medical Center	Anderson	South Carolina	United States	29621
130	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
131	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29304
132	Brooke Army Medical Center	Fort Sam Houston	Texas	United States	78234
133	Veterans Affairs Medical Center - San Antonio (Murphy)	San Antonio	Texas	United States	78209
134	Cancer Therapy and Research Center	San Antonio	Texas	United States	78229
135	University Hospital - San Antonio	San Antonio	Texas	United States	78229
136	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78284
137	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
138	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah	United States	84112
139	St. Joseph Hospital Community Cancer Center	Bellingham	Washington	United States	98225
140	Olympic Hematology and Oncology	Bremerton	Washington	United States	98310
141	Cancer Care Center at Skagit Valley Hospital	Mt. Vernon	Washington	United States	98273
142	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98104
143	Group Health Central Hospital	Seattle	Washington	United States	98104
144	Harborview Medical Center	Seattle	Washington	United States	98104
145	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington	United States	98114
146	University Cancer Center at University of Washington Medical Center	Seattle	Washington	United States	98195
147	Cancer Care Northwest - Spokane South	Spokane	Washington	United States	99202
148	Cancer Center at Southwest Washington Medical Center	Vancouver	Washington	United States	98668
149	Central Washington Hospital	Wenatchee	Washington	United States	98801
150	Wenatchee Valley Clinic	Wenatchee	Washington	United States	98801
151	Welch Cancer Center	Sheridan	Wyoming	United States	82801