Melanoma (Skin) Clinical Trial
Official title:
Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD4+ Antigen-Specific T Cell Clones for Patients With Metastatic Melanoma
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.
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.
;
Primary Purpose: Treatment
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