A Phase I Trial Testing Mart-1 Peptide Immunization in Malignant Melanoma
- 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
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.
Primary Purpose: Treatment
John A Glaspy, MD
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|