Combination Chemotherapy With or Without Interleukin-2 and Interferon Alfa in Treating Patients With Metastatic Melanoma

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00003027

Collaborator

National Cancer Institute (NCI) (NIH), Southwest Oncology Group (Other), Cancer and Leukemia Group B (Other)

482

Enrollment

Locations

5.1

Patients Per Site

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Interferon alfa may interfere with the growth of tumor cells. It is not yet known whether combination chemotherapy plus interleukin-2 and interferon alfa is more effective than combination chemotherapy alone for metastatic melanoma.

PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without interleukin-2 and interferon alfa in treating patients who have metastatic melanoma that cannot be treated by surgery.

Condition or Disease	Intervention/Treatment	Phase
Melanoma (Skin)	Biological: aldesleukin Biological: filgrastim Biological: recombinant interferon alfa Drug: cisplatin Drug: dacarbazine Drug: vinblastine	Phase 3

Detailed Description

OBJECTIVES:

Compare response rate, duration of response, and survival rate in patients with metastatic malignant melanoma treated with cisplatin, vinblastine, and dacarbazine with or without interleukin-2 and interferon alfa-2b.
Determine the toxic effects of these regimens in this patient population.

OUTLINE: This is a randomized study. Patients are stratified according to performance status (0 vs 1), prior interferon (yes vs no), and number of involved sites. Patients are randomized to one of two treatment arms.

Arm I: Patients receive cisplatin IV over 30 minutes daily immediately followed by vinblastine IV on days 1-4. Patients also receive dacarbazine IV over 60 minutes on day 1 following vinblastine.
Arm II: Patients receive treatment as in arm I. Patients also receive interleukin 2 (IL-2) IV continuously on days 1-4 and interferon alfa-2b subcutaneously (SC) daily before IL-2 on days 1-4 and after IL-2 on day 5, followed by filgrastim (G-CSF) (SC) daily on days 7-16.

Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 6 weeks, every 3 months for 18 months, every 6 months for 18 months, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 482 patients will be accrued for this study within 3.5 years.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

482 participants

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

A Randomized Phase III Trial of Concurrent Biochemotherapy With Cisplatin, Vinblastine, Dacarbazine, IL-2 and Interferon A-2B Versus Cisplatin, Vinblastine, Dacarbazine Alone in Patients With Metastatic Malignant Melanoma

Study Start Date :

Oct 1, 1997

Actual Primary Completion Date :

Jul 1, 2007

Outcome Measures

Primary Outcome Measures

Overall survival []

Secondary Outcome Measures

Response rate (complete and partial response) []
Durable complete response rate []
Response duration []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed surgically incurable metastatic malignant melanoma
Measurable disease
No active brain metastases or edema
No leptomeningeal disease
No ocular melanoma

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-1

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 9 g/dL

Hepatic:

Bilirubin no greater than 1.5 mg/dL
SGOT less than 3 times the upper limit of normal unless due to liver metastases

Renal:

Creatinine less than 1.5 mg/dL OR
Creatinine clearance at least 75 mL/min

Cardiovascular:

No congestive heart failure
No symptoms of coronary artery disease
No serious cardiac arrhythmias
No prior myocardial infarction on EKG
Normal cardiac stress test required for the following:
Over 50 years of age
Abnormal EKG
Prior history of cardiac disease

Pulmonary:

No symptomatic pulmonary disease
FEV1 greater than 2.0 L OR at least 75% predicted if over 50 years of age or with history of pulmonary symptoms

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No significant infection
HIV negative
No other prior malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
No organ allografts
No significant disease other than malignancy
No seizure disorder

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No prior interleukin-2 therapy for metastatic disease
At least 4 weeks since prior vaccine therapy
At least 4 weeks since prior adjuvant immunotherapy

Chemotherapy:

No prior chemotherapy for disease

Endocrine therapy:

No concurrent corticosteroids

Radiotherapy:

No prior radiation therapy to measurable disease site unless disease is clearly progressive
At least 4 weeks since prior radiation therapy for local control or palliation and recovered

Surgery:

Recovered from prior surgery

Other:

No prior systemic therapy for metastatic disease
At least 3 months since definitive therapy for brain metastases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MBCCOP - Gulf Coast	Mobile	Alabama	United States	36688
2	CCOP - Greater Phoenix	Phoenix	Arizona	United States	85006-2726
3	Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)	Phoenix	Arizona	United States	85012
4	Veterans Affairs Medical Center - Tucson	Tucson	Arizona	United States	85723
5	Arizona Cancer Center	Tucson	Arizona	United States	85724
6	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
7	Veterans Affairs Medical Center - Little Rock (McClellan)	Little Rock	Arkansas	United States	72205
8	Cancer Center and Beckman Research Institute, City of Hope	Duarte	California	United States	91010-3000
9	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90033-0804
10	Veterans Affairs Medical Center - West Los Angeles	Los Angeles	California	United States	90073
11	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California	United States	90095-1781
12	Veterans Affairs Outpatient Clinic - Martinez	Martinez	California	United States	94553
13	CCOP - Bay Area Tumor Institute	Oakland	California	United States	94609-3305
14	Chao Family Comprehensive Cancer Center	Orange	California	United States	92868
15	University of California Davis Medical Center	Sacramento	California	United States	95817
16	UCSF Cancer Center and Cancer Research Institute	San Francisco	California	United States	94143-0128
17	CCOP - Santa Rosa Memorial Hospital	Santa Rosa	California	United States	95403
18	David Grant Medical Center	Travis Air Force Base	California	United States	94535
19	University of Colorado Cancer Center	Denver	Colorado	United States	80010
20	Veterans Affairs Medical Center - Denver	Denver	Colorado	United States	80220
21	CCOP - Atlanta Regional	Atlanta	Georgia	United States	30342-1701
22	Dwight David Eisenhower Army Medical Center	Fort Gordon	Georgia	United States	30905-5650
23	Cancer Research Center of Hawaii	Honolulu	Hawaii	United States	96813-2424
24	MBCCOP - University of Illinois at Chicago	Chicago	Illinois	United States	60612-7323
25	Veterans Affairs Medical Center - Chicago (Westside Hospital)	Chicago	Illinois	United States	60612
26	CCOP - Central Illinois	Decatur	Illinois	United States	62526
27	Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)	Hines	Illinois	United States	60141
28	Loyola University Medical Center	Maywood	Illinois	United States	60153
29	University of Kansas Medical Center	Kansas City	Kansas	United States	66160-7353
30	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
31	Veterans Affairs Medical Center - Wichita	Wichita	Kansas	United States	67218
32	Veterans Affairs Medical Center - Lexington	Lexington	Kentucky	United States	40502-2236
33	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky	United States	40536-0084
34	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
35	Tulane University School of Medicine	New Orleans	Louisiana	United States	70112
36	Louisiana State University Health Sciences Center - Shreveport	Shreveport	Louisiana	United States	71130-3932
37	Veterans Affairs Medical Center - Shreveport	Shreveport	Louisiana	United States	71130
38	Boston Medical Center	Boston	Massachusetts	United States	02118
39	Veterans Affairs Medical Center - Boston (Jamaica Plain)	Jamaica Plain	Massachusetts	United States	02130
40	Veterans Affairs Medical Center - Ann Arbor	Ann Arbor	Michigan	United States	48105
41	CCOP - Ann Arbor Regional	Ann Arbor	Michigan	United States	48106
42	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0912
43	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379
44	Veterans Affairs Medical Center - Detroit	Detroit	Michigan	United States	48201-1932
45	Henry Ford Hospital	Detroit	Michigan	United States	48202
46	Providence Hospital - Southfield	Southfield	Michigan	United States	48075-9975
47	CCOP - Duluth	Duluth	Minnesota	United States	55805
48	Veterans Affairs Medical Center - Biloxi	Biloxi	Mississippi	United States	39531-2410
49	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
50	Veterans Affairs Medical Center - Jackson	Jackson	Mississippi	United States	39216
51	Keesler Medical Center - Keesler AFB	Keesler AFB	Mississippi	United States	39534-2576
52	Veterans Affairs Medical Center - Kansas City	Kansas City	Missouri	United States	64128
53	CCOP - Kansas City	Kansas City	Missouri	United States	64131
54	St. Louis University Health Sciences Center	Saint Louis	Missouri	United States	63110
55	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri	United States	63141
56	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65807
57	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
58	Veterans Affairs Medical Center - Albuquerque	Albuquerque	New Mexico	United States	87108-5138
59	MBCCOP - University of New Mexico HSC	Albuquerque	New Mexico	United States	87131
60	Veterans Affairs Medical Center - Albany	Albany	New York	United States	12208
61	Herbert Irving Comprehensive Cancer Center	New York	New York	United States	10032
62	University of Rochester Medical Center	Rochester	New York	United States	14642
63	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina	United States	27104-4241
64	Veterans Affairs Medical Center - Cincinnati	Cincinnati	Ohio	United States	45220-2288
65	Barrett Cancer Center, The University Hospital	Cincinnati	Ohio	United States	45267-0501
66	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
67	CCOP - Columbus	Columbus	Ohio	United States	43206
68	Veterans Affairs Medical Center - Dayton	Dayton	Ohio	United States	45428
69	CCOP - Dayton	Kettering	Ohio	United States	45429
70	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio	United States	43623-3456
71	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma	United States	73104
72	Veterans Affairs Medical Center - Oklahoma City	Oklahoma City	Oklahoma	United States	73104
73	Veterans Affairs Medical Center - Portland	Portland	Oregon	United States	97207
74	CCOP - Columbia River Program	Portland	Oregon	United States	97225
75	OHSU Cancer Institute	Portland	Oregon	United States	97239
76	Veterans Affairs Medical Center - Charleston	Charleston	South Carolina	United States	29401-5799
77	Medical University of South Carolina	Charleston	South Carolina	United States	29425-0721
78	CCOP - Greenville	Greenville	South Carolina	United States	29615
79	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
80	Simmons Cancer Center - Dallas	Dallas	Texas	United States	75235-8852
81	Brooke Army Medical Center	Fort Sam Houston	Texas	United States	78234-6200
82	University of Texas Medical Branch	Galveston	Texas	United States	77555-0565
83	Veterans Affairs Medical Center - Houston	Houston	Texas	United States	77030
84	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78284-7845
85	Veterans Affairs Medical Center - San Antonio (Murphy)	San Antonio	Texas	United States	78284
86	Veterans Affairs Medical Center - Temple	Temple	Texas	United States	76504
87	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
88	Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112-5550
89	Veterans Affairs Medical Center - Salt Lake City	Salt Lake City	Utah	United States	84148
90	CCOP - Virginia Mason Research Center	Seattle	Washington	United States	98101
91	Swedish Cancer Institute	Seattle	Washington	United States	98104
92	Veterans Affairs Medical Center - Seattle	Seattle	Washington	United States	98108
93	CCOP - Northwest	Tacoma	Washington	United States	98405-0986
94	Madigan Army Medical Center	Tacoma	Washington	United States	98431-5048