Melanoma (Skin) Clinical Trial
Official title:
A Phase I Study of Peptide Based Vaccine Therapy in Patients With High-Risk or Metastatic Melanoma
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill
tumor cells. Colony-stimulating factors such as sargramostim may increase the number of
immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with
sargramostim may kill more tumor cells.
PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy with or
without sargramostim in treating patients who have metastatic melanoma.
OBJECTIVES:
- Compare the safety of melanoma peptide vaccine with or without sargramostim (GM-CSF) in
patients with high-risk or metastatic melanoma.
- Compare changes in peptide-specific cellular and humoral immunologic profiles in
patients treated with these regimens.
- Compare tumor response in patients treated with these regimens.
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment
arms.
- Arm I: Patients receive melanoma peptide vaccine comprising tyrosinase leader injected
at 2 separate sites, Melan-A ELA injected at another site, NY-ESO-1a and NY-ESO-1b
combined and injected at one site, and MAGE-10.A2 injected at another site,
intradermally once weekly on weeks 1-6.
- Arm II: Patients receive vaccine as in arm I. Patients also receive sargramostim
(GM-CSF) subcutaneously daily beginning 2 days before each vaccination and continuing
for 5 days.
Treatment in both arms continues through week 6 in the absence of disease progression or
unacceptable toxicity.
Patients are followed at 2 weeks.
PROJECTED ACCRUAL: A total of 20 patients (10 per treatment arm) will be accrued for this
study within 18 months.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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