Study on Gene-Modified T Cells With or Without Decitabine for Treating Advanced Cancers with NY-ESO-1

Sponsor: Roswell Park Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT02650986

This clinical trial is exploring a new treatment using gene-modified T cells, with or without the chemotherapy drug decitabine, to see if it can help treat advanced cancers that express the NY-ESO-1 gene. The study aims to find the best dose and understand the side effects of this treatment.

Patient Parameters

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Program Overview

This study is testing a new approach to treat advanced cancers that have spread and express the NY-ESO-1 gene. It involves modifying a patient's T cells, which are immune cells that can attack cancer, to better recognize and kill cancer cells. These modified T cells are then given back to the patient. The study is also looking at whether adding the chemotherapy drug decitabine can improve the treatment's effectiveness. Researchers want to find out if this combination works better than using the modified T cells alone.

Description

The main goal of this study is to see if using gene-modified T cells is safe and feasible for treating advanced cancers that express the NY-ESO-1 gene. Researchers will also look at how well these modified T cells stay in the body and how they affect the cancer. The study will test if these T cells can help shrink tumors and improve the body's immune response against cancer.

Participants will be divided into two groups. In the first group, patients will have their blood cells collected and receive a chemotherapy drug called cyclophosphamide before getting the modified T cells. In the second group, patients will receive an additional drug, decitabine, before the modified T cells. If patients respond well to the treatment, they may receive a second infusion of the modified T cells if their cancer progresses.

After treatment, patients will have regular follow-up visits to monitor their health and the treatment's effects. These visits will continue for several years to ensure long-term safety and effectiveness.

Eligibility Criteria

Inclusion Criteria

Have advanced melanoma, ovarian, primary peritoneal, fallopian tube carcinoma, or synovial sarcoma that cannot be removed by surgery or has spread.
Have tried standard treatments without success or cannot tolerate them.
Have a tumor that tests positive for the NY-ESO-1 gene (except for one specific group where this is not required).
Be 18 years or older (12 years or older for one specific group).
Have a life expectancy of more than 3 months.
Have at least one measurable tumor.
Be in good overall health with an ECOG performance status of 0 or 1.
Agree to use effective birth control during the study and for 6 months after.
Have adequate blood cell counts and organ function.
Be willing to undergo a procedure to collect blood cells for the study.
Have tissue available for NY-ESO-1 testing or be willing to provide a new sample.
Understand the study and agree to sign informed consent.
Have a caregiver available and arrange for lodging and transportation as needed.
For a second T cell infusion, must have shown disease control after the first infusion and meet all other criteria.

Exclusion Criteria

Have known allergies to any study drugs.
Are currently participating in another clinical trial.
Have uncontrolled illnesses, such as active infections or heart problems.
Have a history of severe autoimmune diseases requiring treatment.
Have gastrointestinal conditions that could increase risk.
Need systemic steroids or immunosuppressive drugs.
Have active infections like HIV, hepatitis B or C.
Have active brain metastases unless controlled.
Have dementia or mental health issues that prevent understanding the study.
Are pregnant or breastfeeding.
Cannot commit to follow-up assessments.

Locations

FACILITY	ZIP	CITY	STATE
Roswell Park Cancer Institute	14263	Buffalo	New York

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