This trial is terminated!
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Your journey
1What's a trial
4Get in touch
More info
You can access this
clinical trial
if you have
Metastatic Cancer, Metastatic Melanoma or Metastatic Renal Cancer
and you are
between 18 and 99
years old
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

Background: - A new cancer treatment involves collecting white blood cells from an individual, modifying them to secrete IL-2 and target the ESO-1 protein expressed on some cancers, and returning them to the body. The cells may then be able to seek out the cancer cells and destroy them. Some kinds of cancer contain a protein called ESO-1, which is found on the surface of the cells. Doctors want to modify white blood cells to have an anti-ESO-1 effect, and use them to treat the cancer that has the ESO-1. In addition to adding genes that target the ESO-1 protein to the cells, the genes for IL-12 are added to the cells. IL-12 is a protein that stimulates the immune system. This type of therapy is called gene transfer. Objectives: - To test the safety and effectiveness of anti-ESO-1/IL-12 white blood cells against metastatic cancer. Eligibility: - Individuals at least 18 years of age who have metastatic cancer that expresses ESO-1 and has not responded to standard treatments. Design: - Participants will be screened with a medical history and physical exam. They will also have blood tests and imaging studies. - Participants will have leukapheresis about a month before the treatment to collect white blood cells. - They will have chemotherapy 5 days before the treatment to suppress the immune system, and prepare the body for the anti-ESO-1/IL-12 cells. - The anti-ESO-1/IL-12 cells will be given as an infusion. - Participants will be monitored in the hospital during their recovery from the treatment. - Participants will have regular followup exams every 1 to 6 months. The exams will include blood tests, imaging studies, and other studies. Due to toxicities seen with the regimen, it was decided not to pursue the phase 2 portion of the study.

Provided treatments

  • Drug: Fludarabine
  • Drug: Cyclophosphamide
  • Other: IL-12 & Anti-NY ESO1 TCR PBL

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01457131. The sponsor of the trial is National Cancer Institute (NCI) and it is looking for 2 volunteers for the current phase.
Official trial title:
Phase I/II Study of Metastatic Cancer That Expresses NY-ESO-1 Using Lymphodepleting Conditioning Followed by Infusion of Gene Engineered Lymphocytes Cotransduced With Genes Encoding IL-12 and Anti-NY ESO-1 TCR