Vaccine Therapy Compared With Interferon Alfa in Treating Patients With Stage III Melanoma
NCT ID: NCT00003715
Last Updated: 2015-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
425 participants
INTERVENTIONAL
1998-12-31
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of melanoma vaccine with that of interferon alfa-2b in treating patients who have stage III melanoma that has spread to regional lymph nodes following surgery.
Detailed Description
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OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to number of metastatic lymph node sites (1 vs more than 1), number of positive lymph nodes in a single site (none vs 1 or more), presence of intransit metastases (yes vs no), and evidence of extranodal extension (yes vs no). Patients are randomized to one of two treatment arms. Arm I: Patients receive autologous tumor cell vaccine intradermally once a week for 7 weeks followed by a booster injection at 6 months. BCG is given concurrently with vaccine as an immune-stimulator for doses 2-8. Patients also receive cyclophosphamide 6 days after the first vaccine injection. Arm II: Patients receive interferon alfa-2b IV for 5 consecutive days a week for 4 weeks followed by maintenance doses given subcutaneously 3 times a week for 48 weeks. Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 386-425 patients will be accrued for this study.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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BCG vaccine
autologous tumor cell vaccine
recombinant interferon alfa
chemotherapy
cyclophosphamide
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Life expectancy: At least 6 months Hematopoietic: Hematocrit at least 30% WBC at least 3,000/mm3 Hepatic: Hepatitis B and C negative Renal: Not specified Other: Not pregnant or nursing No active serious infection No active autoimmune disease HIV negative No other malignancy within the last 5 years except squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder carcinoma, early stage prostate cancer, or noninvasive melanoma No active severe depression or psychiatric disorder with psychotic symptoms No uncontrolled thyroid abnormalities
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since prior cytotoxic drugs (except for isolated limb perfusion) Endocrine therapy: No concurrent systemic corticosteroids Radiotherapy: At least 6 months since prior radiotherapy Surgery: See Disease Characteristics Other: At least 30 days since prior investigational drugs
18 Years
120 Years
ALL
No
Sponsors
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AVAX Technologies
INDUSTRY
Responsible Party
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Principal Investigators
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Karen Doak
Role: STUDY_CHAIR
AVAX Technologies
Locations
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Cancer and Blood Institute of the Desert
Rancho Mirage, California, United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States
Columbia - HCA Cancer Research Network
North Miami Beach, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Georgia Cancer Specialists
Decatur, Georgia, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
Hubert H. Humphrey Cancer Center
Robbinsdale, Minnesota, United States
Midwest Oncology Consortium
Kansas City, Missouri, United States
Jersey Shore Cancer Center
Neptune City, New Jersey, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Palmetto Hematology/Oncology Associates
Spartanburg, South Carolina, United States
Countries
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Other Identifiers
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AVAX-A/100/0101
Identifier Type: -
Identifier Source: secondary_id
CDR0000066824
Identifier Type: -
Identifier Source: org_study_id