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

Phase 1

Completed

• Conditions: Ovarian Cancer; Peritoneal Cavity Cancer

• Registration Number: NCT00101257
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief 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.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-01-07
• Study First Submitted QC: 2005-01-07
• Study First Posted: 2005-01-10
• Study Completion: 2010-03
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-05
• Last Update Posted: 2010-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and toxicity
Duration of in vivo persistence
Antitumor effects

Trial Locations

Locations (1)

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States