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This study evaluates the patient's own T cells (a type of immune cell), with or without Cyclophosphamide and Fludarabine, in patients with recurrent, platinum-resistant ovarian, peritoneal, or fallopian tube cancer. It included patients whose tumors express the WT1 (Wilms Tumor Gene 1) protein. It was a Phase 1 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
DISEASE CHARACTERISTICS:
* Pathologically confirmed ovarian epithelial carcinoma, primary peritoneal cavity carcinoma, or fallopian tube carcinoma
* Recurrent or persistent disease after treatment with platinum-based chemotherapy
* Must have platinum-resistant or intolerant disease
* Evaluable disease, as demonstrated by serological (i.e., CA 125), radiological, or pathological studies
* Tumor must express the Wilms Tumor Gene 1 (WT1) peptide, as detected by IHC analysis of banked (i.e., paraffin-embedded) or freshly biopsied tumor nodules
* Only WT1 tumors graded as moderate to strong (scores 4-12) according to adapted German Immunoreactive Score criteria are considered positive
* No prior or concurrent brain metastases
PATIENT CHARACTERISTICS:
* Karnofsky performance status (PS) 70-100% OR WHO PS 0-1
* Life expectancy ≥ 6 months
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60mL/min
* ALT and AST ≤ 2.5 times upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 times ULN
* Adequate pulmonary and cardiac function
* No clinical evidence of cardiopulmonary disease, which, in the opinion of the investigator, would preclude enrollment
* Able to keep scheduled visits
* No known hepatitis B or C infection
* No known HIV positivity
* No evidence of bowel obstruction
* No clinically significant heart disease (New York Heart Association class III or IV)
* No active infections requiring antibiotics within two weeks of study entry
* No serious intercurrent illness requiring hospitalization
* No history of primary or secondary immunodeficiency or autoimmune disease
* No other cancers except nonmelanomatous skin cancer within the past 5 years
* Not pregnant or lactating
* No other issue which, in the opinion of the treating physician, would make the patient ineligible for the study
PRIOR CONCURRENT THERAPY:
* More than 3 weeks since prior anticancer therapy (i.e., chemotherapy, biologic therapy, or immunotherapy)
* No history of whole abdominal radiation therapy