Melanoma Clinical Trial

Vaccine Therapy Compared With Interferon Alfa in Treating Patients With Stage III Melanoma

Summary

RATIONALE: Vaccines made from a person's melanoma cells may make the body build an immune response to kill tumor cells. Interferon alfa may interfere with the growth of the cancer cells.

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.

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Full Description

OBJECTIVES: I. Compare the relapse-free and overall survival rates in patients with stage III melanoma treated with autologous tumor vaccine versus interferon alfa-2b as postsurgical adjuvant therapy. II. Compare the safety and tolerability of these regimens in this patient population.

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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed melanoma metastatic to regional lymph nodes with a clinically palpable mass Must have clinical evidence of the following: Metastases in 1 nodal site All other nodes microscopically negative No intransit metastases No extranodal extension OR Metastases in more than 1 nodal site More than 1 positive lymph node in a single site Intransit metastases Extranodal extension Must have undergone complete resection of tumor, measuring at least 2 cm in diameter, within the past 6 weeks No distant metastases

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

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

425

Study ID:

NCT00003715

Recruitment Status:

Terminated

Sponsor:

AVAX Technologies

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There are 17 Locations for this study

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Cancer and Blood Institute of the Desert
Rancho Mirage California, 92270, United States
Yale Comprehensive Cancer Center
New Haven Connecticut, 06520, United States
Columbia - HCA Cancer Research Network
North Miami Beach Florida, 33180, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
Georgia Cancer Specialists
Decatur Georgia, 30033, United States
University of Illinois at Chicago
Chicago Illinois, 60612, United States
Lutheran General Cancer Care Center
Park Ridge Illinois, 60068, United States
James Graham Brown Cancer Center
Louisville Kentucky, 40202, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids Michigan, 49546, United States
Hubert H. Humphrey Cancer Center
Robbinsdale Minnesota, 55422, United States
Midwest Oncology Consortium
Kansas City Missouri, 64111, United States
Jersey Shore Cancer Center
Neptune New Jersey, 07753, United States
Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States
University of Pennsylvania Cancer Center
Philadelphia Pennsylvania, 19104, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia Pennsylvania, 19107, United States
Palmetto Hematology/Oncology Associates
Spartanburg South Carolina, 29303, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

425

Study ID:

NCT00003715

Recruitment Status:

Terminated

Sponsor:


AVAX Technologies

How clear is this clinincal trial information?

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