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Gene Therapy in Treating Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004178
Recruitment Status : Completed
First Posted : April 19, 2004
Last Update Posted : June 10, 2011
Beth Israel Deaconess Medical Center
Information provided by:
Roger Williams Medical Center

Brief Summary:

RATIONALE: Inserting a gene that has been created in the laboratory into a person's white blood cells may make the body build an immune response to kill cancer cells.

PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have cancer that has not responded to previous therapy.

Condition or disease Intervention/treatment Phase
Cancer Biological: therapeutic autologous lymphocytes Phase 1

Detailed Description:


  • Determine the safety and maximum tolerated dose of T cells activated in vitro and modified with chimeric anti-CEA immunoglobulin T cell receptors (Ig TCR) in patients with CEA expressing adenocarcinoma.
  • Determine the pharmacokinetics of this regimen by the persistence of modified T cells in the blood of these patients.
  • Evaluate the immunogenicity of murine sequences in chimeric anti-CEA Ig TCR.
  • Assess immunologic parameters which correlate with the efficacy of this regimen in these patients.
  • Evaluate, in a preliminary manner, the efficacy of this regimen in patients with CEA bearing tumors.

OUTLINE: This is a dose escalation study.

Peripheral blood lymphocytes (PBL) are harvested. PBL are activated in vitro and then modified with recombinant chimeric anti-CEA immunoglobulin T cell receptors (Ig TCR). Ig TCR modified T cells are reinfused over 30-60 minutes.

The estimated maximum tolerated dose (MTD) is defined as the dose at which 2 of 6 patients experience unacceptable toxicity. If the MTD is not reached within the first cohort, a second cohort of 3 patients then receives 4 doses of modified T cells at a higher dose.

Patients are followed every 2 weeks for 2 months.

PROJECTED ACCRUAL: A total of 6-9 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I Study of T Cells Modified With Chimeric AntiCEA Immunoglobulin-T Cell Receptors (IgTCR) in Adenocarcinoma
Study Start Date : April 1998
Primary Completion Date : December 2000
Study Completion Date : December 2001

Information from the National Library of Medicine

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


  • Histologically proven CEA expressing adenocarcinoma

    • Serum CEA levels greater than 10 ng/mL
    • Failed standard therapy
  • Measurable disease



  • 18 and over

Performance status:

  • 0-2

Life expectancy:

  • Greater than 2 months


  • Not specified


  • No significant hepatic disease
  • Bilirubin no greater than 3 mg/dL
  • No active clinical disease caused by hepatitis B


  • No significant renal disease
  • Creatinine no greater than 3 mg/dL


  • No significant cardiovascular disease


  • No significant pulmonary disease


  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No significant endocrine, rheumatologic, or allergic disease
  • No active clinical disease caused by cytomegalovirus or tuberculosis
  • HIV negative


Biologic therapy:

  • Not specified


  • At least 4 weeks since prior chemotherapy

Endocrine therapy:

  • Not specified


  • At least 4 weeks since prior radiotherapy


  • Not specified

Information from the National Library of Medicine

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 identifier (NCT number): NCT00004178

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Roger Williams Medical Center
Beth Israel Deaconess Medical Center
Study Chair: Richard P. Junghans, MD, PhD Beth Israel Deaconess Medical Center

Responsible Party: Richard Junghans, Roger Williams Medical Center Identifier: NCT00004178     History of Changes
Other Study ID Numbers: CDR0000067388
First Posted: April 19, 2004    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: May 2006

Keywords provided by Roger Williams Medical Center:
stage III colon cancer
stage IV colon cancer
stage III gastric cancer
stage IV gastric cancer
recurrent gastric cancer
recurrent non-small cell lung cancer
stage II pancreatic cancer
stage III pancreatic cancer
recurrent pancreatic cancer
stage III rectal cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
stage II esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer
recurrent esophageal cancer
stage III cervical cancer
recurrent cervical cancer
stage IVB cervical cancer
stage IVA cervical cancer
adenocarcinoma of the prostate
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
adenocarcinoma of the stomach
extensive stage small cell lung cancer

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type