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ACTIVE NOT RECRUITING
NCT03017131
PHASE1

Genetically Modified T Cells and Decitabine in Treating Patients With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Sponsor: Roswell Park Cancer Institute

View on ClinicalTrials.gov

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.

Official title: A Phase I Open Label Clinical Trial Evaluating the Safety and Efficacy of Adoptive Transfer of NY-ESO-1 TCR Engineered Autologous T Cells in Combination With Decitabine in Patients With Recurrent or Treatment Refractory Ovarian Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2017-12-08

Completion Date

2032-03-23

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

BIOLOGICAL

Aldesleukin

Given SC

DRUG

Cyclophosphamide

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

Locations (1)

Roswell Park Cancer Institute

Buffalo, New York, United States