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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Ovarian Cancer, Peritoneal Cavity Cancer

Intervention / Treatment
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* Biological: therapeutic autologous lymphocytes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: therapeutic autologous lymphocytes|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and toxicity |  |  | 
| Duration of in vivo persistence |  |  | 
| Antitumor effects |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, peritoneal cavity cancer