Trial Information

Melanoma Peptide Vaccines (MART1 Analog, gp100 and Survivin) With GM-CSF and Low-Dose IL-2 as Immune Adjuvants, A Pilot Study

OBJECTIVES:

- Determine the safety and toxicity profile of peptide vaccine comprising MART-1 antigen,
gp100 antigen, and survivin antigen in combination with sargramostim (GM-CSF)
emulsified in incomplete Freund's adjuvant (IFA) with or without low-dose aldesleukin
in patients with stage II-IV melanoma.

- Determine the immunologic effects of two different doses of GM-CSF coemulsified with
melanoma peptides in IFA in these patients.

- Determine the immunological effects of low-dose aldesleukin therapy administered after
peptide immunization in these patients.

- Collect preliminary data on the impact of the vaccine on clinical outcomes in these
patients.

OUTLINE: This is a pilot study. Patients are stratified according to disease stage (II vs
III or IV). Patients are sequentially enrolled into 1 of 4 different dose schedules.

- Dose schedule 1: Patients receive gp100 antigen, MART-1 antigen, survivin antigen, and
sargramostim (GM-CSF) emulsified in incomplete Freund's adjuvant (peptide vaccine)
subcutaneously (SC) on day 1. Treatment repeats every 21 days for 4 courses in the
absence of disease progression or unacceptable toxicity.

- Dose schedule 2: Patients receive peptide vaccine as in group 1. Patients also receive
low-dose aldesleukin SC twice daily on days 7-20. Treatment repeats every 21 days for 4
courses in the absence of disease progression or unacceptable toxicity.

- Dose schedule 3: Patients receive peptide vaccine as in group 1 except with a higher
dose of GM-CSF. Treatment repeats every 21 days for 4 courses in the absence of disease
progression or unacceptable toxicity.

- Dose schedule 4: Patients receive peptide vaccine as in group 1 except with a higher
dose of GM-CSF. Patients also receive low-dose aldesleukin SC twice daily on days 7-20.
Treatment repeats every 21 days for 4 courses in the absence of disease progression or
unacceptable toxicity.

Cohorts of 5 patients receive treatment at subsequent dose schedule until the maximum
tolerated dose schedule (MTDS) is determined. The MTDS is defined as the dose schedule
preceding that at which 2 of 5 patients experience dose-limiting toxicity within the first
course.

After completion of study therapy, patients are followed every 3 months for up to 2 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.