PHASE I STUDY TO EVALUATE THE SAFETY OF CELLULAR ADOPTIVE IMMUNOTHERAPY USING GENETICALLY MODIFIED AND UNMODIFIED AUTOLOGOUS CD8+ TYROSINASE-SPECIFIC T CELLS FOR PATIENTS WITH METASTATIC MELANOMA
- Assess the safety and toxicity of cellular adoptive immunotherapy using autologous CD8+
antigen-specific T-cell clones in patients with metastatic melanoma.
- Estimate the duration of in vivo persistence of adoptively transferred CD8+
antigen-specific cytotoxic T-cell clones in these patients.
- Evaluate the antitumor effects of CD8+ antigen-specific T-cell clones in these
OUTLINE: Autologous peripheral blood mononuclear cells are harvested and then CD8+ cytotoxic
T-lymphocyte (CTL) clones targeting melanosomal antigens are generated ex vivo. Patients
receive cellular adoptive immunotherapy comprising autologous CD8+ CTL clones over 30
minutes on day 1. Patients also receive interleukin-2 subcutaneously every 12 hours on days
1-14 of courses 2-3. Treatment repeats every 3 weeks for 3 courses in the absence of disease
progression or unacceptable toxicity.
Patients are followed for approximately 1 year after the last infusion.
PROJECTED ACCRUAL: Approximately 20 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|