Gene Therapy Using Anti-CEA Cells to Treat Metastatic Cancer
Status:
Terminated
Trial end date:
2011-11-01
Target enrollment:
Participant gender:
Summary
Background:
- 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.
Objectives:
- 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.
Eligibility:
- 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.
Design:
- 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.