Genetically Modified T Cells + Decitabine for Ovarian Cancer
Trial Summary
What is the purpose of this trial?
This trial studies a treatment combining enhanced immune cells and a drug to target difficult-to-treat ovarian and related cancers. The approach aims to improve the body's ability to find and destroy cancer cells.
Research Team
Emese Zsiros
Principal Investigator
Roswell Park Cancer Institute
Eligibility Criteria
This trial is for patients with recurrent or refractory ovarian, primary peritoneal, or fallopian tube cancer. Participants must have HLA-A*02;01 positivity, good performance status (ECOG 0-1), life expectancy over 4 months, adequate organ function and blood counts, measurable disease by irRECIST criteria, and be at least 4 weeks out from prior treatments. Women of childbearing potential must agree to use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive decitabine IV daily over 1 hour on days -8 to -6, cyclophosphamide IV over 2 hours on days -4 and -3, and genetically engineered NY-ESO-1-specific T lymphocytes IV and IP on day 0, followed by low-dose IL-2 for 2 weeks from Day 1 to Day 14.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Decitabine
- Genetically Engineered NY-ESO-1-specific T Lymphocytes
Decitabine is already approved in European Union, United States, Canada, Japan for the following indications:
- Acute myeloid leukemia
- Myelodysplastic syndromes
- Myelodysplastic syndromes
- Acute myeloid leukemia
- Myelodysplastic syndromes
- Acute myeloid leukemia
- Myelodysplastic syndromes
- Acute myeloid leukemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Roswell Park Cancer Institute
Lead Sponsor
National Cancer Institute (NCI)
Collaborator