Melanoma (Skin) Clinical Trial
Official title:
A Phase I Trial of a Vaccine Combining Tyrosinase/GP100/Mart-1 Peptides Emulsified With Montanide ISA 51 With ProGP for Patients With Resected Stages III and IV Melanoma
RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to
kill tumor cells. Vaccine therapy plus filgrastim combined with a specific protein may be a
more effective treatment for melanoma.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in
treating patients with stage III or stage IV melanoma that has been completely removed
during surgery.
OBJECTIVES: I. Determine the maximum tolerated dose of filgrastim (G-CSF)-fetal liver
tyrosine kinase-3 (Flt3K) fusion protein when combined with melanoma peptide vaccine
comprising tyrosinase:368-376 peptide, gp100:209-217 antigen, and MART-1:26-35 antigen
emulsified in Montanide ISA-51 in patients with completely resected stage III or IV
melanoma. II. Determine the toxicity and safety of this regimen in these patients. III.
Determine the immune responses to tyrosinase, MART-1, and gp100 antigens in patients before,
during, and after receiving these vaccinations.
OUTLINE: This is a dose escalation, multicenter study of filgrastim (G-CSF)-fetal liver
tyrosine kinase-3 (Flt3K) (G-CSF-Flt3K) fusion protein. Patients receive melanoma peptide
vaccine comprising tyrosinase:368-376 peptide, gp100:209-217 antigen, and MART-1:26-35
antigen emulsified in Montanide ISA-51 subcutaneously (SQ) monthly for 6 months, and then at
9 and 12 months for a total of 8 vaccinations. Patients receive G-CSF-Flt3K fusion protein
SQ daily for 3 days before, immediately after, and then daily for 6 days after each
vaccination. Cohorts of 6-10 patients receive escalating doses of G-CSF-Flt3K fusion protein
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 of 6-10 patients experience dose limiting toxicity. Patients are
followed every 3 months through year 2 after resection, every 6 months for 3 years, and then
annually thereafter until disease progression.
PROJECTED ACCRUAL: A total of 30-50 patients will be accrued for this study within 12-18
months.
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Primary Purpose: Treatment
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