OBJECTIVES:

• Determine the toxic effects of gp100:209-217 (210M) and human papilloma virus (HPV)-16 E7(12-20) peptide vaccine in patients with primary melanoma at least 1 mm thick.
• Determine the T-cell response to modified self-gp100:209-217 (210M) peptide and unmodified parental gp100 peptide in these patients.
• Determine the T-cell response to the control HLA-A2.1-restricted cytotoxic T-lymphocyte epitope of HPV-16 E7(12-20) in these patients.
• Determine whether analysis of antigen-specific T cells using specific HLA-A2/peptide tetramers is an effective method for monitoring the immune response in patients undergoing peptide vaccination compared to ELISPOT, LDA, and measurement of intracellular cytokine production (fastimmune).
• Compare induction of primary peptide-specific T-cell immune responses to self gp100 peptide versus foreign E7 peptide in these patients.
• Compare immune response induced by vaccinating every 2 weeks for 6 months (13 vaccinations) vs every 3 weeks for 6 months (9 vaccinations) in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive gp100:209-217 (210M) and HPV-16 E7(12-20) peptides mixed with Montanide ISA-51 subcutaneously at the site of the primary melanoma and in the extremities and abdomen. Vaccinations continue every 2 weeks for 6 months (13 total injections).
• Arm II: Patients receive vaccinations as in arm I every 3 weeks for 6 months (9 total injections).

Patients undergo sentinel lymph node biopsy and possible wide local excision approximately 10 days after the second vaccination.

Patients are followed every 3 months for 6 months, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter until recurrence.

PROJECTED ACCRUAL: A total of 36 patients (18 per arm) will be accrued for this study within 14 months.

DISEASE CHARACTERISTICS:

• Histologically proven primary melanoma of Breslow thickness at least 1.0 mm

  • Prior wide local excision allowed if within past 3 months
  • No prior lymph node dissection
• HLA-A2 positive
• No ascites or pleural effusions
• No clinically detectable distant metastases

PATIENT CHARACTERISTICS:

Age:

• Over 16

Performance status:

• Karnofsky 80-100%

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 9 g/dL

Hepatic:

• Bilirubin no greater than 2.0 mg/dL

Renal:

• Creatinine no greater than 2 mg/dL

Pulmonary:

• No chronic obstructive pulmonary disease

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No significant systemic infection
• HIV negative
• No history of major psychiatric illness that would preclude study compliance
• No concurrent illness requiring systemic corticosteroids
• No other significant medical illness that would increase risk of immunotherapy
• No other cancers or deemed at low risk of recurrence

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• No concurrent systemic corticosteroids

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics
• Recovered from prior major surgery