A Phase I Study of gp100 Human Melanoma Peptide Vaccine With Incomplete Freund's Adjuvant

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Metastatic melanoma that is HLA-A2 positive.
• •No primary melanoma of ocular or mucosal origin.
• •Measurable or resected metastatic disease required.
• •PRIOR/CONCURRENT THERAPY:
• •BIOLOGIC THERAPY: No prior (greater than 30 days) or concurrent Biologic Therapy.
• •CHEMOTHERAPY: No prior (greater than 30 days) or concurrent chemotherapy.
• •ENDOCRINE THERAPY: No prior (greater than 30 days) or concurrent hormone therapy.
• •No requirement for steroids.
• •RADIOTHERAPY: No prior (greater than 30 days) or concurrent radiotherapy.
• •SURGERY: Not specified.
• •PATIENT CHARACTERISTICS:
• •Age: 18 and over.
• •Performance Status: ECOG 0 or 1.
• •Life Expectancy: More than 3 months.
• •HEMATOPOIETIC: No coagulation disorder.
• •HEPATIC:
• •Bilirubin no greater than 2.0 mg/dL.
• •No Hepatitis BsAg antibody.
• •RENAL: Creatinine no greater than 2.0 mg/dL.
• •CARDIOVASCULAR: No major cardiovascular illness.
• •PULMONARY: No major respiratory illness.
• •OTHER:
• •No previous allergic reaction to incomplete Freund's adjuvant.
• •HIV negative.
• •No active systemic infection.
• •Not pregnant or lactating.