Melanoma (Skin) Clinical Trial
Official title:
Vaccination With Synthetic Melanoma Peptides Administered With GM-CSF-in-Adjuvant in Patients With Advanced Melanoma
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients
with stage III or stage IV melanoma that cannot be removed by surgery.
OBJECTIVES:
- Determine the antitumor immune response in patients with unresectable stage III or IV
melanoma treated with vaccine comprising multiple synthetic melanoma peptides,
sargramostim (GM-CSF), and Montanide ISA-51.
OUTLINE: Patients receive vaccine comprising multiple synthetic melanoma peptides,
sargramostim (GM-CSF), and Montanide ISA-51 on days 1, 8, 15, 29, 36, and 43. Patients
undergo removal of the lymph node draining the vaccination site on day 22 to assess immune
response.
PROJECTED ACCRUAL: A maximum of 29 patients will be accrued for this study.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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