Ovarian Cancer 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 Advanced Ovarian Cancer
RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, stimulate the
immune system in different ways and stop tumor cells from growing.
PURPOSE: This phase I trial is studying the side effects and best dose of cellular adoptive
immunotherapy in treating patients with stage III or stage IV ovarian cancer or primary
peritoneal cancer.
OBJECTIVES:
Primary
- 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
cancer.
- Determine the duration of in vivo persistence of this drug in these patients.
Secondary
- 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
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