Vaccine Therapy in Treating Patients With Metastatic Melanoma
RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill melanoma cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with metastatic melanoma.
Biological: MART-1 antigen
Biological: gp100:209-217(210M) peptide vaccine
Biological: therapeutic autologous dendritic cells
Biological: tyrosinase peptide
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Overall survival [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Time to progression [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||October 2003|
|Study Completion Date:||June 2005|
|Primary Completion Date:||June 2005 (Final data collection date for primary outcome measure)|
- 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 cocktail.
- 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 progression.
PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00334776
|United States, California|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90089-9181|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0942|
|Study Chair:||Jeffrey S. Weber, MD, PhD||University of Southern California|