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Trial record 1 of 1 for:    09-C-0047
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Gene Therapy Using Anti-CEA Cells to Treat Metastatic Cancer

This study has been terminated.
(Study was terminated due to poor accrual.)
Information provided by (Responsible Party):
Steven Rosenberg, M.D., National Institutes of Health Clinical Center (CC) Identifier:
First received: June 17, 2009
Last updated: October 18, 2015
Last verified: October 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 Intervention Phase
Metastatic Cancer
Biological: PG13-CEA_TCR (Anti-CEA TCR PBL)
Drug: Aldesleukin
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Safety

Enrollment: 3
Study Start Date: December 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gene Therapy Treatment Biological: PG13-CEA_TCR (Anti-CEA TCR PBL) Drug: Aldesleukin
720,000 IU/kg intravenous over 15 minutes every 8 hours for up to 5 days
Other Name: Proleukin

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  1. Metastatic cancer that expresses carcinoembryonic antigen (CEA) as assessed by one of the following methods:

    • Immunohistochemistry of resected tissue, assessed by immunohistochemistry (IHC) in the Clinical Laboratory Improvement Amendments (CLIA) approved test in the Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI), National Institutes of Health (NIH). Since the affinity of the antibody is weak, a result of greater than or equal to 1+ is considered positive.
    • Detection of elevated levels of circulating CEA using a standard clinical enzyme-linked immunosorbent (ELISA) assay. Results will be considered positive if CEA level is greater than 10 mcg/L.
    • Metastatic cancer diagnosis will be confirmed by the Laboratory of Pathology at the NCI.
  2. Hepatic metastases must represent the life limiting components of the disease defined as liver disease with a very high likelihood of causing the death of a patient according to the best clinical judgment of the attending physician.
  3. Patients must have previously received systemic standard care (or effective salvage chemotherapy regimens) for metastatic disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurred.
  4. Greater than or equal to 18 years of age.
  5. Willing to sign a durable power of attorney
  6. Able to understand and sign the Informed Consent Document
  7. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1.
  8. Life expectancy of greater than three months.
  9. Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after receiving the preparative regimen.
  10. Patients must be human leukocyte antigen (HLA-A*0201) positive
  11. Serology:

    1. Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.)
    2. Seronegative for hepatitis B antigen and hepatitis C antibody unless antigen negative.
  12. Hematology:

    1. Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim.
    2. White blood cell (WBC) (greater than 3000/mm^3.
    3. Platelet count greater than 100,000/mm^3.
    4. Hemoglobin greater than 8.0 g/dl.
  13. Chemistry:

    1. Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less or equal to 2.5 times the upper limit of normal.
    2. Serum creatinine less than or equal to 1.6 mg/dl.
    3. Total bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.
  14. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo).


  1. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
  2. Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
  3. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
  4. Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
  5. Concurrent systemic steroid therapy
  6. History of severe immediate hypersensitivity reaction to any of the agents used in this study.
  7. History of coronary revascularization or ischemic symptoms
  8. Any patient known to have an left ventricular ejection fraction (LVEF) less than or equal to 45%.
  9. Documented LVEF of less than or equal to 45% tested in patients with:

    1. History of ischemic heart disease, chest pain, or clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block
    2. Age greater than or equal to 60 years old
  10. Documented forced expiratory volume (FEV1) less than or equal to 60% predicted tested in patients with:

    1. A prolonged history of cigarette smoking (20 pk/year of smoking within the past 2 years).
    2. Symptoms of respiratory dysfunction
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Please refer to this study by its identifier: NCT00923806

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Steven Rosenberg, M.D. National Cancer Institute, National Institutes of Health
  More Information

Responsible Party: Steven Rosenberg, M.D., Principal Investigator, National Institutes of Health Clinical Center (CC) Identifier: NCT00923806     History of Changes
Obsolete Identifiers: NCT00809978
Other Study ID Numbers: 090047
Study First Received: June 17, 2009
Last Updated: October 18, 2015

Keywords provided by National Institutes of Health Clinical Center (CC):
Metastatic Cancer
Tumor Regression

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents processed this record on April 28, 2017