Gene Therapy Using Anti-CEA Cells to Treat Metastatic Cancer
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|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.
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): 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|