Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cell Clones Following Fludarabine Lymphodepletion for Patients With Metastatic Melanoma
- Determine the safety and toxicity of adoptive immunotherapy comprising autologous CD8+
antigen-specific cytotoxic T-lymphocyte (CTL) clones after fludarabine in patients with
stage IV melanoma.
- Determine the duration of in vivo persistence of these CTL clones in these patients.
- Determine the antitumor effect of this regimen in these patients.
OUTLINE: This is an open-label, nonrandomized study.
Patients undergo leukapheresis or weekly phlebotomy for the collection of peripheral blood
mononuclear cells from which autologous antigen-specific CD8+ cytotoxic T-lymphocyte (CTL)
clones are generated. Patients receive autologous antigen-specific CD8+ CTL clones IV over
30-60 minutes on days 0 and 21 in the absence of rapid disease progression or unacceptable
toxicity. Patients also receive fludarabine IV once daily on days 14-18.
Patients are followed for up to 1 year.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 3 years.
Masking: Open Label, Primary Purpose: Treatment
Cassian Yee, MD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|