Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
Melanoma (Skin)

About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage II melanoma, stage III melanoma, stage IV melanoma, recurrent melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed malignant melanoma Stage IIB, IIC, III, or IV disease Patients with stage III or IV disease who are free of disease after surgical resection* are eligible Patients free of disease after surgical resection* must have refused high-dose interferon alfa OR experienced recurrent disease during prior treatment with interferon alfa NOTE: *Patients who underwent surgical resection must have had the surgery within the past year HLA-A0201 positive No detectable brain metastases PATIENT CHARACTERISTICS: Age Any age Performance status Karnofsky 80-100% Life expectancy Not specified Hematopoietic WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10 g/dL No active bleeding Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) Albumin ≥ 3.5 g/dL AST and ALT ≤ 2.5 times ULN Lactate dehydrogenase ≤ 2 times ULN No clinical history of hepatitis B or C Renal Creatinine ≤ 2.0 mg/dL Immunologic No clinical history of HIV No clinical history of HTLV-1 No active infection requiring antibiotics within the past 72 hours No history of collagen vascular, rheumatologic, or other autoimmune disorder No grade 1 fever within the past 72 hours Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Weight ≥ 25 kg No serious underlying medical condition that would preclude study participation No preexisting uveal or choroidal eye disease PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics More than 4 weeks since prior immunotherapy No prior immunization with any class of vaccine containing gp100, including whole cell, shed antigen, or cell lysate vaccines Chemotherapy More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy No concurrent corticosteroids that would preclude study participation Radiotherapy More than 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery See Disease Characteristics Other Recovered from all prior therapy No other concurrent medication that would preclude study participation No other concurrent investigational agents No other concurrent systemic therapy
Sites / Locations
- Memorial Sloan-Kettering Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
human gp100 DNA vaccine
mouse gp100 DNA vaccine
Patients receive human gp100 DNA vaccine intramuscularly (IM) once in weeks 1, 4, and 7. Patients then receive mouse gp100 DNA vaccine IM once in weeks 10, 13, and 16.
Patients receive mouse gp100 DNA vaccine IM once in weeks 1, 4, and 7. Patients then receive human gp100 DNA vaccine IM once in weeks 10, 13, and 16