Spots Global Cancer Trial Database for Biological Therapy in Treating Patients With Metastatic Melanoma

Study Description

Brief Summary: RATIONALE: Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Treating a person's white blood cells in the laboratory and reinfusing them may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic melanoma.

Detailed Description: OBJECTIVES: Primary * Determine the maximum tolerated dose of autologous CD4+ antigen-specific T-cells for cellular adoptive immunotherapy in patients with metastatic melanoma. * Determine the safety and toxicity of this regimen in these patients. * Determine the duration of in vivo persistence of adoptively transferred CD4+ antigen-specific T-cell clones in these patients. Secondary * Determine the antitumor effects of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients undergo leukapheresis to collect peripheral blood mononuclear cells. CD4+ antigen-specific T-cell clones are generated over the next 2-3 months using immunogenic peptides MART1, tyrosinase, or gp100. Patients receive autologous CD4+ antigen-specific T-cells IV over 30 minutes. Cohorts of 3-6 patients receive escalating doses of autologous CD4+ antigen-specific T-cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed on days 1 and 3 post T-cell infusion, and then once weekly for 12 weeks. PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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