A Phase II Trial of an Intradermally Administered MART-1gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Matured With a Cytokine Cocktail for Patients With Metastatic Melanoma
- Determine clinical response in HLA-A *0201-positive patients with metastatic melanoma
treated with an intradermally administered vaccine comprising autologous dendritic
cells pulsed with MART-1, gp100, and tyrosinase peptides and matured with a cytokine
- Determine immunologic response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo apheresis to collect dendritic cells (DC). Autologous DC are pulsed ex vivo
with tumor antigen peptides derived from MART-1: 26-35 (27L), gp100: 209-217 (210M), and
tyrosinase: 368-376 (370D) and matured with a cytokine cocktail comprising interleukin
(IL)-4, IL-6, IL-1β, sargramostim (GM-CSF), tumor necrosis factor-α, and prostaglandin E2.
Patients receive 12 intradermal injections of DC vaccine over 30 minutes on days 1, 8, 22,
and 36. Treatment repeats every 8 weeks for up to 3 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically until disease
PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Jeffrey S. Weber, MD, PhD
USC/Norris Comprehensive Cancer Center
United States: Federal Government
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|