Status:
COMPLETED
Cellular Adoptive Immunotherapy in Treating Patients With Stage III or Stage IV Ovarian Cancer or Primary Peritoneal Cancer
Lead Sponsor:
Fred Hutchinson Cancer Center
Conditions:
Ovarian Cancer
Peritoneal Cavity Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
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 ...
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 ca...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00101257
Start Date
October 1 2004
End Date
March 1 2010
Last Update
May 7 2010
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024