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More info
You can access this
clinical trial
if you have
Metastatic Cancer
and you are
over 18
years old
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

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.

Provided treatments

  • Biological: PG13-CEA_TCR (Anti-CEA TCR PBL)
  • Drug: Aldesleukin
Tris trial is registered with FDA with number: NCT00923806. The sponsor of the trial is National Cancer Institute (NCI) and it is looking for 3 volunteers for the current phase.
Official trial 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