Trial Information

A Randomized Phase II Trial to Determine the Immune Response to a Mutated gp100 Mela

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.