Expired Study
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Seattle, Washington 98109


Purpose:

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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed stage III or IV ovarian epithelial cancer or primary peritoneal cavity cancer meeting 1 of the following criteria: - Progressive* or persistent* disease during or after primary chemotherapy - Recurrent disease < 6 months after completion of primary therapy that had resulted in a complete response - Persistent* or recurrent disease after second-line or additional therapies NOTE: *Progression or persistence can be based on serological (CA 125 > 100 U/mL OR 2 times baseline), radiographic (measurable or evaluable disease), or second-look surgical findings - Tumor expressing NY-ESO-1 determined by IHC or RT-PCR - HLA type expressing DPB*0401, DPB1*0201, DRB1*07 - No CNS metastases PATIENT CHARACTERISTICS: Age - 18 to 75 Performance status - Karnofsky 70-100% Life expectancy - More than 16 weeks Hematopoietic - Not specified Hepatic - Not specified Renal - Creatinine ≤ 2.0 mg/dL Cardiovascular - No congestive heart failure* - No clinically significant hypotension* - No symptoms of coronary artery disease* - No cardiac arrhythmias on EKG requiring drug therapy* - No history of cardiovascular disease* - No other significant cardiovascular abnormalities* NOTE: *Patients with any of the above undergo a stress test and/or echocardiography before being determined ineligible for study participation Pulmonary - FEV_1 ≥ 60% of predicted* - DLCO ≥ 55%* NOTE: *Patients with clinically significant pulmonary dysfunction only Other - Not pregnant or nursing - Fertile patients must use effective contraception - HIV negative - No active infection - No oral temperature > 38.2°C within the past 72 hours - No systemic infection requiring chronic maintenance or suppressive therapy PRIOR CONCURRENT THERAPY: Biologic therapy - No other concurrent immunotherapy (e.g., interleukins, interferons, vaccines, intravenous immunoglobulin, or expanded polyclonal tumor-infiltrating lymphocytes or lymphokine-activated killer cell therapy) Chemotherapy - See Disease Characteristics - At least 3 weeks since prior standard or experimental chemotherapy Endocrine therapy - No concurrent systemic corticosteroids except for treatment-related toxicity Radiotherapy - At least 3 weeks since prior radiotherapy Surgery - See Disease Characteristics Other - At least 3 weeks since prior immunosuppressive therapy - More than 3 weeks since prior investigational drugs and recovered - No other concurrent investigational agents - No concurrent pentoxifylline


NCT ID:

NCT00101257


Primary Contact:

Study Chair
Cassian Yee, MD
Fred Hutchinson Cancer Research Center


Backup Contact:

N/A


Location Contact:

Seattle, Washington 98109
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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