A Phase II Trial of a MART-1/gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Treated With CD40 Ligand/Gamma Interferon With Subcutaneous IL-2 for Patients With Metastatic Melanoma
- Determine the clinical response rate and immune response in HLA-A2 positive patients
with stage III or IV melanoma after receiving autologous dendritic cells pulsed with
melanoma antigen peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) and
treated ex vivo with CD40-ligand and interferon gamma, followed by interleukin-2 in
- Determine the toxicities of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients undergo leukapheresis to harvest autologous dendritic cells (ADCs). Melanoma
peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) are pulsed separately onto
ADCs, which are also treated ex vivo with CD40-ligand, interferon gamma, interleukin-4,
sargramostim (GM-CSF), and Candida albicans skin test reagent. Patients receive each
melanoma peptide pulsed ADC vaccine separately via 3 successive 10 minute infusions on day
1. Patients then receive interleukin-2 subcutaneously every 12 hours on days 2-6. Treatment
repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable
Patients are followed at 4 weeks, then every 3 months for 2 years, then every 6 months for 3
years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 18-24
Primary Purpose: Treatment
Jeffrey S. Weber, MD, PhD
USC/Norris Comprehensive Cancer Center
United States: Federal Government
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|