Gene Therapy Using Anti-CEA Cells to Treat Metastatic Cancer
|ClinicalTrials.gov Identifier: NCT00923806|
Recruitment Status : Terminated (Study was terminated due to poor accrual.)
First Posted : June 18, 2009
Last Update Posted : October 20, 2015
- Carcinoembryonic antigen (CEA) is a protein present mostly in cancer cells.
- An experimental procedure developed for treating patients with cancer uses blood cells found in their tumors or bloodstream. These cells are genetically modified using the anti-CEA gene and a type of virus. The modified cells (anti-CEA cells) are grown in the laboratory and then given back to the patient to try to decrease the size of the tumors. This is called gene therapy.
- To determine whether advanced cancers that that express the CEA antigen can be treated effectively with lymphocytes (white blood cells) that have been genetically engineered to contain an anti-CEA protein.
- Patients 18 years of age and older with metastatic cancer (cancer that has spread beyond the original site) and for whom standard treatments are not effective.
- Patients' tumors express the CEA antigen.
- Patients have the human leukocyte (HLA-A*0201) antigen.
- Workup with scans, x-rays and other tests.
- Leukapheresis to obtain cells for preparing the anti-CEA cells for later infusion.
- 1 week of chemotherapy to prepare the immune system for receiving the anti-CEA cells.
- Infusion of anti-CEA cells, followed by interleukin-2 (IL-2) treatment. The cells are given as an infusion through a vein. IL-2 is given as a 15-minute infusion through a vein every 8 hours for a maximum of 15 doses.
- 1-2 weeks of recovery from the effects of chemotherapy and IL-2.
- Periodic follow-up clinic visits after hospital discharge for physical examination, review of treatment side effects, laboratory tests and scans every 1 to 6 months.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer||Biological: PG13-CEA_TCR (Anti-CEA TCR PBL) Drug: Aldesleukin||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Metastatic Cancer That Expresses Carcinoembryonic Antigen (CEA) Using Lymphodepleting Conditioning Followed by Infusion of Anti-CEA TCR-Gene Engineered Lymphocytes|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
|Experimental: Gene Therapy Treatment||
Biological: PG13-CEA_TCR (Anti-CEA TCR PBL)
720,000 IU/kg intravenous over 15 minutes every 8 hours for up to 5 days
Other Name: Proleukin
- clinical response of the administration of anti-CEA TCR engineered peripheral blood lymphocytes in patients receiving the non-myeloablative conditioning regimen and aldesleukin in patients with metastatic cancer.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00923806
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Steven Rosenberg, M.D.||National Cancer Institute, National Institutes of Health|