Interferon Alfa With or Without Vaccine Therapy in Treating Patients With Metastatic Melanoma

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00002767

Collaborator

(none)

300

Enrollment

Locations

11.1

Patients Per Site

Study Details

Study Description

Brief Summary

RATIONALE: Interferon alfa may interfere with the growth of cancer cells.Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether melanoma vaccine plus interferon alfa is more effective than interferon alfa alone in treating patients with metastatic melanoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without vaccine therapy in treating patients with metastatic melanoma.

Condition or Disease	Intervention/Treatment	Phase
Melanoma (Skin)	Biological: Detox-B adjuvant Biological: recombinant interferon alfa	Phase 3

Detailed Description

OBJECTIVES: I. Compare survival following immunotherapy with an allogeneic melanoma vaccine plus interferon alfa-2b (IFN-A) vs. IFN-A alone in patients with metastatic melanoma. II. Assess the safety and toxicity of immunotherapy with an allogeneic melanoma vaccine plus IFN-A in these patients. III. Compare the frequencies of durable complete responses in each treatment group. IV. Compare overall clinical objective response, duration of response, and time to disease progression in each treatment group. V. Compare the effects of immunotherapy with an allogeneic melanoma vaccine plus IFN-A vs IFN-A alone on quality of life in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by location of metastatic sites (visceral and bone vs nonvisceral and lung) and number of metastatic sites (1 vs 2 vs 3 or more). Patients are randomized to one of two treatment arms. Arm I: Patients receive allogenic melanoma cell lysate vaccine with detoxified endotoxin subcutaneously (SQ) weekly on weeks 1-5 and 8-12. Interferon alfa (IFN-A) SQ is administered three times a week beginning on week 4. Patients with responding or stable disease receive vaccine monthly beginning on week 16. IFN-A continues in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive IFN-A SQ three times a week beginning on week 1. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before, during, and after treatment. Patients are followed every 3 months.

PROJECTED ACCRUAL: Approximately 300 patients will be entered over 2 years.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

PHASE III TRIAL OF MELACINE PLUS INTERFERON ALFA-2B VERSUS INTERFERON ALFA-2B IN PATIENTS WITH DISSEMINATED MALIGNANT MELANOMA

Study Start Date :

Jan 1, 1996

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Histologically confirmed malignant melanoma that is metastatic (any pT, any N, M1 by AJCC staging) Measurable disease by physical exam or noninvasive radiologic procedure No concurrent or prior diagnosis of ocular melanoma No CNS metastases No patients who can be rendered NED by surgery unless patient declines surgery

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy:

At least 4 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL AST or ALT no greater than 3 times normal No evidence of hepatic failure No active hepatitis Renal: Creatinine clearance at least 40 mL/min Cardiovascular: No myocardial infarction within 6 months No decompensating congestive heart failure No unstable angina No current symptomatic arrhythmia Other: No known HIV antibody No thyroid abnormality uncontrollable by medication No medical, sociological, or psychological impediment to study compliance No pre-existing psychiatric condition (especially depression) or history of severe psychiatric disorder No autoimmune disease (e.g., systemic lupus erythematosus, multiple sclerosis, ankylosing spondylitis) No concurrent malignancy except nonmelanomatous skin cancer Not pregnant or nursing Negative pregnancy test Effective contraception required of fertile women No history of egg allergies

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 12 months since interferon alfa or melanoma vaccine No prior immunotherapy for metastatic disease No concurrent cytokines or levamisole Chemotherapy: No prior chemotherapy for metastatic disease At least 4 months since adjuvant therapy No concurrent chemotherapy Endocrine therapy: At least 1 week since corticosteroids No concurrent immunosuppressives (e.g., azathioprine or cyclosporine) Radiotherapy: Prior radiotherapy for metastatic disease allowed Surgery: See Disease Characteristics Prior surgery for metastatic disease allowed

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama Comprehensive Cancer Center	Birmingham	Alabama	United States	35294
2	Beckman Research Institute, City of Hope	Duarte	California	United States	91010
3	University of California San Diego Cancer Center - La Jolla	La Jolla	California	United States	92093-0686
4	Kaiser Permanente Medical Center - Oakland	Oakland	California	United States	94611
5	Kaiser Permanente Medical Center-Sacramento	Sacramento	California	United States	95825
6	UCSF Cancer Center and Cancer Research Institute	San Francisco	California	United States	94115-0128
7	Kaiser Permanente Medical Group - San Francisco	San Francisco	California	United States	94115
8	Kaiser Permanente Medical Center - Santa Clara	Santa Clara	California	United States	95051-5386
9	Kaiser Permanente Medical Center - Vallejo	Vallejo	California	United States	94589
10	University of Connecticut Health Center	Farmington	Connecticut	United States	06360-7106
11	Yale Comprehensive Cancer Center	New Haven	Connecticut	United States	06520-8028
12	Sylvester Cancer Center, University of Miami	Miami	Florida	United States	33136
13	Adventist Health System/Sunbelt, Inc.	Orlando	Florida	United States	32803
14	Emory University School of Medicine	Atlanta	Georgia	United States	30322
15	Lutheran General Cancer Care Center	Park Ridge	Illinois	United States	60068
16	University of Louisville Hospital	Louisville	Kentucky	United States	40202
17	Creighton University Cancer Center	Omaha	Nebraska	United States	68131-2197
18	Norris Cotton Cancer Center	Lebanon	New Hampshire	United States	03756
19	University of New Mexico Cancer Research & Treatment Center	Albuquerque	New Mexico	United States	87131
20	Interlakes Oncology/Hematology PC	Rochester	New York	United States	14623
21	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
22	Barrett Cancer Center, The University Hospital	Cincinnati	Ohio	United States	45219
23	Christ Hospital	Cincinnati	Ohio	United States	45219
24	CCOP - Columbus	Columbus	Ohio	United States	43206
25	Hematology Oncology Consultants Inc	Columbus	Ohio	United States	43235
26	Oregon Cancer Center at Oregon Health Sciences University	Portland	Oregon	United States	97201-3098
27	Southwest Regional Cancer Center	Austin	Texas	United States	78705