Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma
Melanoma (Skin)
About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage III melanoma, stage IV melanoma, recurrent melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed high-risk stage III or IV melanoma Stage III disease less than 6 months after surgical resection Completed prior interferon alfa therapy OR Progressive disease or major adverse events during prior interferon alfa therapy Stage III disease at least 6 months after surgical resection Declined, failed, or completed prior standard therapy Stage IV disease Declined, failed, or completed prior standard therapy HLA-A2 positive No CNS metastases unless treated and stable PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Life expectancy: At least 4 months Hematopoietic: Neutrophil count at least 1,500/mm3 Lymphocyte count at least 500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL (10.0 g/dL if less than 50 kg) No bleeding disorder Hepatic: Bilirubin no greater than 2.0 mg/dL No hepatitis B or C positivity Renal: Creatinine no greater than 1.8 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease Other: HIV negative No other serious illness No serious infection requiring antibiotics No history of immunodeficiency disease or autoimmune disease No psychiatric or addictive disorder that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior bone marrow or stem cell transplantation At least 4 weeks since prior immunotherapy or biologic therapy No other concurrent immunotherapy or biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) No concurrent chemotherapy Endocrine therapy: No concurrent systemic corticosteroids No concurrent steroids except topical or inhalational steroids Concurrent hormonal therapy allowed Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior surgery Other: At least 4 weeks since prior investigational agents Concurrent noncytotoxic anticancer therapy allowed No concurrent immunosuppressive therapy No concurrent antihistamines No concurrent non-steroidal anti-inflammatory drugs except in low doses for prevention of an acute cardiovascular event or pain control
Sites / Locations
- Herbert Irving Comprehensive Cancer Center at Columbia University