Modified White Blood Cells That Secrete IL-2 and Express a Protein That Targets the ESO-1tumor Protein for Metastatic Cancer
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|ClinicalTrials.gov Identifier: NCT01457131|
Recruitment Status : Terminated
First Posted : October 21, 2011
Last Update Posted : January 8, 2019
- 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 metastatic cancer.
- 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 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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer Metastatic Melanoma Metastatic Renal Cancer||Drug: Fludarabine Drug: Cyclophosphamide Other: IL-12 & Anti-NY ESO1 TCR PBL||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Study Start Date :||October 6, 2011|
|Actual Primary Completion Date :||August 7, 2013|
|Actual Study Completion Date :||August 7, 2013|
- Drug: Fludarabine
50 mg/m2, IV(in the vein)on day 5 of each 25 day cycle
- Drug: Cyclophosphamide
60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days
- Other: IL-12 & Anti-NY ESO1 TCR PBL
10(7) cells to 3 X 10(10) cells
- To evaluate the safety of the IL-12 and anti-NY-ESO-1 engineered PBL in patients receiving a non-myeloablative conditioning regimen, and to determine if patients with metastatic cancer will have clinical tumor regression following this regimen. [ Time Frame: 4 years ]
- To determine the in vivo survival of cotransduced gene-engineered cells. [ Time Frame: 4 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01457131
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Steven A Rosenberg, M.D.||National Cancer Institute (NCI)|