Trial of 2nd Generation Anti-CEA Designer T Cells in Gastric Cancer

This study has been withdrawn prior to enrollment.
(low accrual)
Sponsor:
Information provided by (Responsible Party):
Roger Williams Medical Center
ClinicalTrials.gov Identifier:
NCT00429078
First received: January 30, 2007
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

This study proposes to determine the safety and tolerability of 2nd generation designer T cells in patients with gastric cancer.Designer T cells are prepared by removing white blood cells from the participant, and then modifying these cells so that they recognize tumor antigen(CEA). These modified cells are then re infused back into the participant so that they can attack and kill tumor cells.Eligibility for this study is diagnosis of carcinoma of the stomach with failure to respond to standard curative therapy. Tumors must express CEA as demonstrated by elevated serum CEA >10ng/ml and be measurable radiologically or by physical exam.


Condition Intervention Phase
Gastric Cancer
Genetic: 2nd Generation Designer T Cells
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of 2nd Generation Anti-CEA Designer T Cells in Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Roger Williams Medical Center:

Enrollment: 0
Study Start Date: July 2007
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Detailed Description:

T cells can penetrate virtually every biologic space and have the power to dispose of normal or malignant cells as seen in viral and autoimmune diseases and in the rare spontaneous remissions of cancer. However, T cells are easily tolerized to self or tumor antigens and "immune surveil¬lance" has manifestly failed in every cancer that is clinically apparent. It is the goal of this study to supply the specificities and affinities to patient T cells without regard for their "endogenous" T cell receptor repertoire, directed by antibody-defined recognition to kill malignant cells based on their expression of antigen. We will achieve this by preparing chimeric IgCD28TCR genes in mammalian expression vectors to yield "designer T cells" from normal patient cells. Prior studies in model systems demonstrated that recombinant IgCD28TCR could direct modified T cells to respond to antigen targets with IL2 secretion, cellular proliferation, and cytotoxicity, the hallmarks of an effective, self-sustaining immune response. It therefore becomes of paramount interest to extend these studies to a human system of widespread clinical relevance to explore the clinical potential of this new technology. The target antigen for these studies is carcinoembryonic antigen (CEA), which is prominently expressed on tumors of the stomach, colon and rectum, breast, pancreas and other sites.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CEA expressing Gastric Cancer/GE Junction (>10ng/ml)
  • Must have measurable disease radiologically or by physical exam
  • Must have failed potentially curative standard therapy
  • Must be 18 years of age or older
  • No serious concomitant disease

Exclusion Criteria:

  • Prior investigational treatment
  • Requiring systemic steroids
  • Serious medical conditions
  • Concurrent malignancies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429078

Sponsors and Collaborators
Roger Williams Medical Center
Investigators
Principal Investigator: Richard P Junghans, PhD, MD Roger Williams Hospital
  More Information

No publications provided

Responsible Party: Roger Williams Medical Center
ClinicalTrials.gov Identifier: NCT00429078     History of Changes
Other Study ID Numbers: 3020-01A1
Study First Received: January 30, 2007
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Roger Williams Medical Center:
Gastric Cancer
T Cells
Gene Transfer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on July 22, 2014