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.

Condition	Treatment or Intervention	Phase
stage III melanoma	Drug: autologous tumor cell vaccine  Drug: BCG  Drug: cyclophosphamide  Drug: interferon alfa	Phase II

Further Study Details: 

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.

PROTOCOL OUTLINE: This is an open-label, randomized, multicenter study. 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed melanoma metastatic to regional lymph nodes with a clinically palpable mass
• Must have undergone complete resection of tumor, measuring at least 2 cm in diameter, within the past 6 weeks
• No distant metastases

--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

--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; At least 5 years since prior malignancy 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

California
      Cancer and Blood Institute of the Desert, Rancho Mirage,  California,  92270,  United States
Connecticut
      Yale Comprehensive Cancer Center, New Haven,  Connecticut,  06520-8028,  United States
Florida
      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
      Georgia Cancer Specialists, Decatur,  Georgia,  30033,  United States
Illinois
      Lutheran General Cancer Care Center, Park Ridge,  Illinois,  60068,  United States
      University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States
Kentucky
      James Graham Brown Cancer Center, Louisville,  Kentucky,  40202,  United States
Michigan
      Cancer and Hematology Centers of Western Michigan, Grand Rapids,  Michigan,  49546,  United States
Minnesota
      Hubert H. Humphrey Cancer Center, Robbinsdale,  Minnesota,  55422,  United States
Missouri
      Midwest Oncology Consortium, Kansas City,  Missouri,  64111,  United States
New Jersey
      Cancer Institute of New Jersey, New Brunswick,  New Jersey,  08901,  United States
      Jersey Shore Cancer Center, Neptune,  New Jersey,  07753,  United States
New York
      Herbert Irving Comprehensive Cancer Center, New York,  New York,  10032,  United States
Pennsylvania
      Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia,  Pennsylvania,  19107,  United States
      University of Pennsylvania Cancer Center, Philadelphia,  Pennsylvania,  19104,  United States
South Carolina
      Palmetto Hematology/Oncology Associates, Spartanburg,  South Carolina,  29303,  United States

Study chairs or principal investigators

Ernest W. Yankee,  Study Chair,  AVAX Technologies   

Study ID Numbers:  CDR0000066824; AVAX-A/100/0101
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003715
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08