Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT00101257
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00101257
Study Brief:
Protocol Section:
NCT00101257