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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00101257
Enrollment
18
Registered
2005-01-10
Start date
2004-10-31
Completion date
2010-03-31
Last updated
2010-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer, Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, peritoneal cavity cancer

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.

Interventions

BIOLOGICALtherapeutic autologous lymphocytes

Sponsors

Fred Hutchinson Cancer Center
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Safety and toxicity
Duration of in vivo persistence
Antitumor effects

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026