Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD4+ Antigen-Specific T Cell Clones for Patients With Metastatic Melanoma
- 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.
- 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
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.
Primary Purpose: Treatment
Cassian Yee, MD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|