Cellular Adoptive Immunotherapy in Treating Patients With Stage III or Stage IV Ovarian Cancer or Primary Peritoneal Cancer
|ClinicalTrials.gov Identifier: NCT00101257|
Recruitment Status : Completed
First Posted : January 10, 2005
Last Update Posted : May 7, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Peritoneal Cavity Cancer||Biological: therapeutic autologous lymphocytes||Phase 1|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|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|
|Study Start Date :||October 2004|
|Study Completion Date :||March 2010|
- Safety and toxicity
- Duration of in vivo persistence
- Antitumor effects
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00101257
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109-1024|
|Study Chair:||Cassian Yee, MD||Fred Hutchinson Cancer Research Center|