Genetically Modified T Cells + Decitabine for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Emese Zsiros

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Roswell Park Cancer Institute

No Placebo Group

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.

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

I agree to use effective birth control methods during and after the study for several years.

Leukocytes >= 3 x 10^9/L

Patient must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria

I do not have any ongoing illnesses or social situations that would prevent me from following the study's requirements.

I do not have active hepatitis C or have a recent test showing I'm clear of it.

Lack of availability of a patient for immunological and clinical follow-up assessment

Participant Groups

The trial is testing the safety of genetically modified T cells designed to target NY-ESO-1 protein on tumor cells combined with Decitabine in patients whose cancer has returned or hasn't responded to treatment. Patients' own T cells are collected and engineered before being reintroduced into their body alongside Decitabine to potentially enhance the immune response against cancer.

Group I: Treatment (decitabine, genetically modified T cells) Experimental Treatment 5 Interventions

COURSE 1: 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. Patients also receive aldesleukin SC BID on days 1-14..

Decitabine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Dacogen for:

• Acute myeloid leukemia
• Myelodysplastic syndromes

🇺🇸 Approved in United States as Dacogen for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

🇨🇦 Approved in Canada as Dacogen for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

🇯🇵 Approved in Japan as Dacogen for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Roswell Park Cancer Institute Buffalo, NY

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute Lead Sponsor

National Cancer Institute (NCI) Collaborator

References