Peptide Vaccine With Resiquimod as an Immune Modulator for Patients With Resected Melanoma: A Pilot Study
I. Evaluate the immune response of each immunization regimen and determine an optimal
regimen in terms of immune response to recommend for phase II testing.
I. Evaluate the adverse events profile of each immunization regimen. II. Evaluate
I. Describe the immunological efficacy of the vaccine preparations with Gag267-274
(Gag:267-274 peptide vaccine) and resiquimod, as measured by the frequency and interferon
(IFN)gamma production of peptide-specific cytotoxic T lymphocytes (CTL).
II. Examine immune responses to the tumor antigen analog MART-1a (MART-1 antigen) versus the
OUTLINE: Patients are assigned to 1 of 3 treatment groups.
ARM I: Patients receive MART-1 antigen and Gag:267-274 peptide vaccine emulsified in
Montanide ISA 51 VG subcutaneously (SC) on day 1.
ARM II: Patients receive MART-1 antigen emulsified in Montanide ISA 51 VG SC followed by
resiquimod applied topically on day 1.
ARM III: Patients receive MART-1 antigen and Gag:267-274 peptide vaccine emulsified in
Montanide ISA 51 VG SC followed by resiquimod applied topically on day 1.
In all arms, treatment repeats every 21 days for up to 3 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3, 6, 9, 12 and 24 months.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Immune response of each vaccination regimen, defined as a 2-fold or more increase from pre-treatment levels in the frequency of vaccine peptide-specific CTL as measured by tetramer staining
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true immune response rate will be calculated.
Up to 12 months
Svetomir Markovic, M.D., Ph.D.
United States: Food and Drug Administration
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