NCT00101257

Cellular Adoptive Immunotherapy in Treating Patients With Stage III or Stage IV Ovarian Cancer or Primary Peritoneal Cancer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ovarian Cancer
• Peritoneal Cavity Cancer

Interventions

Type	Name	Description
BIOLOGICAL	therapeutic autologous lymphocytes

Timeline

• Start date: 2004-10-01
• Completion: 2010-03-01
• First posted: 2005-01-10
• Last updated: 2010-05-07

Locations

1 site across 1 country: United States