Genetically Modified T Cells and Decitabine in Treating Patients With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
NCT03017131 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2026-04-06
Summary
This phase I trial studies the side effects of genetically modified T cells and decitabine in treating patients with recurrent or refractory epithelial or non-epithelial ovarian, primary peritoneal, or fallopian tube cancer that has come back or has not responded to previous treatments. White blood cells called T cells are collected via a process called leukapheresis, genetically modified to recognize and attack tumor cells, then given back to the patient. Decitabine may induce and increase the amount of the target protein NY-ESO-1 available on the surface of tumor cells. Giving genetically modified T cells and decitabine may kill more tumor cells.
Conditions
- Recurrent Fallopian Tube Carcinoma
- Recurrent Ovarian Carcinoma
- Recurrent Primary Peritoneal Carcinoma
Interventions
- BIOLOGICAL
-
Aldesleukin
Given SC
- DRUG
-
Given IV
- DRUG
-
Decitabine
Given IV
- BIOLOGICAL
-
Genetically Engineered NY-ESO-1-specific T Lymphocytes
Given IV and IP
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Roswell Park Cancer Institute
lead OTHER
Principal Investigators
-
Emese Zsiros, MD · Roswell Park Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-12-08
- Primary Completion
- 2020-03-23
- Completion
- 2032-03-23
- FDA Drug
- Yes
Countries
- United States
Study Locations
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