Autologous T Cells With or Without Cyclophosphamide and Fludarabine in Treating Patients With Recurrent or Persistent Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer (Fludarabine Treatment Closed as of

• Status: Completed
• Trial end date: 2021-08-03
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected. Treating stem cells collected from the patient's blood in the laboratory may increase the number of immune cells that can mount an immune response against the tumor. The treated stem cells may help destroy any remaining tumor cells (graft-versus-tumor effect). Chemotherapy may also be given to the patient to prepare the bone marrow for the stem cell transplant.

PURPOSE: This phase I trial is studying the side effects and best dose of autologous T cells when given with or without cyclophosphamide and fludarabine in treating patients with recurrent or persistent advanced ovarian epithelial cancer, primary peritoneal cavity cancer, or fallopian tube cancer. (fludarabine treatment closed as of 12/012009)

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Lenograstim

Criteria

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