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Gene and Vaccine Therapy for Cancer
Study Summary
This trial will test whether genetically engineering a patient's white blood cells to create an immune response to the NY-ESO-1 protein can kill cancer cells expressing that protein. The therapy will be given during a stem cell transplant, along with a vaccine made using the NY-ESO-1 protein.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have not had any cancer treatment in the last month.I have a history of chronic gut conditions like IBD or celiac disease.I may need steroids or drugs that weaken my immune system.I have hepatitis B or C and it is currently harming my liver.I do not have dementia or significant changes in my mental status.I am HLA-A*0201 positive.I am willing to undergo at least two tumor biopsies.I have undergone 3 or more treatments that could affect my bone marrow.My liver and bone marrow are working well, as tested in the last 2 months.I have active cancer spread to my brain.My heart's pumping ability is normal and I have no serious heart rhythm problems.I am 50 or older with a heart function (LVEF) below 45%.I have no restrictions on my previous treatments.I am fully active or restricted in physically strenuous activity but can do light work.My cancer is advanced and there are no other treatment options that could improve my survival.I have a tumor that can be safely biopsied.My cancer tests positive for NY-ESO-1.I am willing to undergo at least two leukapheresis procedures.I am 16 years old or older.My autoimmune or chronic inflammatory disease is not currently active.
- Group 1: Treatment (gene and vaccine therapy)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many research subjects are being enrolled in this trial?
"This study is not recruiting at this time, however it was updated as recently as January 5th, 2022. There are 2462 other clinical trials for cancer patients and 954 dendritic cell vaccine therapy trials that are currently enrolling patients if you are interested."
Are there any more patients needed to participate in this research?
"While this specific study isn't looking for new participants, the data on clinicaltrials.gov shows that it was last updated on January 5th, 2022. There are 3416 other trials that are actively recruiting patients."
What is the FDA's opinion on dendritic cell vaccines as a treatment?
"Given that this is a Phase 2 trial, there is only partial evidence of safety for dendritic cell vaccine therapy. Consequently, it received a score of 2."
What other research projects have looked at dendritic cell vaccine therapy?
"Dendritic cell vaccine therapy is being trialled in 954 different studies, 168 of which are Phase 3 trials. Although most of these experiments are conducted in Philadelphia, Pennsylvania, there are28845 locations running these tests."
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