Melanoma Clinical Trial
Official title:
A Phase I Trial Testing Mart-1 Peptide Immunization in Malignant Melanoma
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill
tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients
who have stage IV, or relapsed malignant melanoma.
OBJECTIVES:
- Determine the safety of administering MART-1 peptide-pulsed dendritic cells to patients
with stage IV or relapsed malignant melanoma.
- Determine the immunological and clinical responses in this patient population after this
therapy.
OUTLINE: This is a dose-escalation study.
Patients undergo leukapheresis between days -14 to -8. Mononuclear cells are isolated, used
to generate dendritic cells (DC), and then pulsed with MART-1 peptide. Patients are
vaccinated with MART-1 peptide-pulsed DC either IV or intradermally on days 0, 14, and 28.
Cohorts of 3-6 patients receive escalating doses of MART-1 peptide-pulsed DC until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study.
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