NCT00006113

Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to kill tumor cells. Biological therapies such as interferon gamma and interleukin-2 use different ways to stimulate the immune system and stop cancer cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells. PURPOSE: This phase II trial is studying giving vaccine therapy together with interferon gamma and interleukin-2 in treating patients with stage III or stage IV melanoma.

Detailed description

OBJECTIVES: * 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 vivo. * 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 toxicity. 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 months.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	MART-1 antigen
BIOLOGICAL	aldesleukin
BIOLOGICAL	gp100 antigen
BIOLOGICAL	recombinant CD40-ligand
BIOLOGICAL	recombinant interferon gamma
BIOLOGICAL	recombinant interleukin-4
BIOLOGICAL	sargramostim
BIOLOGICAL	therapeutic autologous dendritic cells
BIOLOGICAL	therapeutic tumor infiltrating lymphocytes
BIOLOGICAL	tyrosinase peptide
RADIATION	Candida albicans skin test reagent

Timeline

• Start date: 1999-06-01
• Primary completion: 2003-05-01
• Completion: 2006-04-01
• First posted: 2003-01-27
• Last updated: 2014-05-22

Locations

1 site across 1 country: United States