Adjuvant Ganglioside GM2-KLH/QS-21 Vaccination: Post-Operative Adjuvant Ganglioside GM2-KLH/QS-21 (BMS-248479) Vaccination Treatment After Resection of Primary Cutaneous Melanoma Thicker Than 1.5mm (AJCC/UICC Stage II, T3-T4N0M0), a 2-Arm Multicenter Randomized Phase III Trial vs. Observation

Date de début de l'étude : 1 décembre 1999

DISEASE CHARACTERISTICS: Histologically confirmed primary stage II melanoma greater than 1.5 mm without evidence of lymph node metastases T3 or T4, N0, M0 Must originate in the skin Wide excision with a minimum of 1-2 cm margin surrounding primary lesion or biopsy scar No more than 56 days since definitive surgical treatment (wide excision) No more than 12 weeks since primary surgery No clinical, radiological, or pathological evidence of incompletely resected disease, lymph node metastases, in-transit metastasis, or any distant metastatic disease PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9.8 g/dL Hepatic: SGOT/SGPT no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN LDH no greater than 2 times ULN Bilirubin no greater than 2 times ULN Hepatitis B and C negative Renal: Creatinine normal Other: Not pregnant or nursing Negative pregnancy test No prior or other concurrent cancer except carcinoma in situ of the cervix or basal or squamous cell skin cancer No autoimmune disorders No conditions requiring systemic treatment with immunosuppressive drugs including treatment with systemic corticosteroids No history of CNS demyelinating or inflammatory disease No hereditary or acquired peripheral neuropathy No other significant medical or surgical condition or psychiatric disorders requiring medication that would preclude study No history of severe allergic reaction to shellfish HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy No other concurrent biologic therapy Chemotherapy: No prior systemic chemotherapy No concurrent cytotoxic chemotherapy Endocrine therapy: No concurrent hormonal therapy except replacement therapy No concurrent corticosteroids No concurrent chronic systemic steroids Radiotherapy: No prior adjuvant radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics Other: No prior preoperative infusion or perfusion therapy No concurrent immunosuppressive medications No other concurrent anticancer therapy