A Phase 1 interventional study of therapeutic autologous lymphocytes in Ovarian Cancer and Peritoneal Cavity Cancer, sponsored by Fred Hutchinson Cancer Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-05-07.
Sponsored by Fred Hutchinson Cancer Center · Phase 1, Interventional, and Treatment
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
Secondary
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 18 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed stage III or IV ovarian epithelial cancer or primary peritoneal cavity cancer meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Safety and toxicity
Duration of in vivo persistence
Antitumor effects
This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.
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Fred Hutchinson Cancer Center