NCT00334776

Vaccine Therapy in Treating Patients With Metastatic Melanoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Conditions

• Intraocular Melanoma
• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	MART-1 antigen
BIOLOGICAL	gp100:209-217(210M) peptide vaccine
BIOLOGICAL	therapeutic autologous dendritic cells
BIOLOGICAL	tyrosinase peptide

Timeline

• Start date: 2003-10-01
• Primary completion: 2005-06-01
• Completion: 2005-06-01
• First posted: 2006-06-08
• Last updated: 2014-05-21

Locations

2 sites across 1 country: United States