Genetically Modified T Cells + Decitabine for Ovarian Cancer
What You Need to Know Before You Apply
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.
Who Is on the Research Team?
Emese Zsiros
Principal Investigator
Roswell Park Cancer Institute
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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