Ovarian Cancer Clinical Trial
Cellular Adoptive Immunotherapy in Treating Patients With Stage III or Stage IV Ovarian Cancer or Primary Peritoneal Cancer
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.
Full 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.
Eligibility 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
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There is 1 Location for this study
Seattle Washington, 98109, United States
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