- 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.
- To test the safety and effectiveness of anti-ESO-1/IL-12 white blood cells against
- Individuals at least 18 years of age who have metastatic cancer that expresses ESO-1 and
has not responded to standard treatments.
- 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
- 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