Gene and Vaccine Therapy for Treating Advanced Cancers
Sponsor: Jonsson Comprehensive Cancer Center
ClinicalTrials ID:NCT01697527
This clinical trial is exploring a new treatment that uses genetically modified white blood cells and a vaccine to help the immune system fight cancer cells that have a specific protein called NY-ESO-1. The treatment is given during a stem cell transplant.
Patient Parameters
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Program Overview
The study aims to see if genetically reprogramming a patient's white blood cells can help the immune system attack cancer cells with the NY-ESO-1 protein. This genetic therapy is combined with a vaccine made from the NY-ESO-1 protein to boost the immune response. The treatment is given during a stem cell transplant, and researchers will monitor how well it works and if it is safe.
Description
The main goals of this study are to see if we can safely give patients a new treatment that includes genetically modified white blood cells and a vaccine, and to see if this treatment can help shrink tumors. The treatment involves using a patient's own white blood cells, which are modified to target cancer cells with the NY-ESO-1 protein. These cells are given back to the patient along with a vaccine and a low dose of a drug called IL-2 to help the immune system.
Before receiving the treatment, patients will undergo a conditioning process with chemotherapy drugs cyclophosphamide and fludarabine to prepare their bodies. The modified cells are then infused into the patient, and the vaccine is given on specific days. Patients will be closely monitored for any side effects and to see how well the treatment is working.
After the treatment, patients will have follow-up visits at regular intervals to check their health and the treatment's effectiveness. These visits will continue for several years to ensure long-term safety and benefits.
Eligibility Criteria
Inclusion Criteria
- Have advanced cancer that cannot be treated with other therapies that improve survival.
- Have at least one tumor that can be biopsied safely.
- Cancer must have the NY-ESO-1 protein.
- Be positive for a specific genetic marker called HLA-A*0201.
- Be 16 years or older.
- Have a life expectancy of more than 3 months.
- Have at least one measurable tumor.
- No restrictions based on previous treatments.
- Be in good overall health with an ECOG performance status of 0 or 1.
- Have adequate blood and liver function based on specific lab tests.
- Be willing to undergo at least two leukapheresis procedures and two tumor biopsies.
- Be willing to provide written informed consent.
Exclusion Criteria
- Have known allergies to any study drugs.
- Have received cancer treatment within one month before starting the study.
- Have a history of autoimmune diseases or chronic inflammatory conditions.
- Have gastrointestinal conditions causing diarrhea or bleeding.
- Require systemic steroids or immunosuppressive drugs.
- Have HIV or other immune deficiencies.
- Have active hepatitis B or C with liver damage.
- Have dementia or altered mental status.
- Have active brain metastases.
- Be pregnant or breastfeeding.
- Have significant heart or lung conditions.
- Have received three or more prior myelotoxic treatments.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California at Los Angeles (UCLA ) | 90095 | Los Angeles | California |
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