Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD4+ Antigen-Specific T Cell Clones for Patients With Advanced Ovarian Cancer
- Determine the safety and toxicity of autologous CD4-positive antigen-specific T cells
in patients with stage III or IV ovarian epithelial cancer or primary peritoneal cavity
- Determine the duration of in vivo persistence of this drug in these patients.
- Determine the antitumor effect of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients undergo leukapheresis for collection of T cells. Responder T cells are stimulated
in vitro with autologous peripheral blood mononuclear cell-derived dendritic cells pulsed
with NY-ESO-1 immunogenic peptides. Patients receive autologous CD4-positive
antigen-specific T cells IV over 30 minutes.
Cohorts of 3-6 patients receive escalating doses of autologous CD4-positive 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 at 4, 8, and 12 weeks and then periodically thereafter for survival.
PROJECTED ACCRUAL: A total of 9-18 patients will be accrued for this study.
Primary Purpose: Treatment
Safety and toxicity
Cassian Yee, MD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|