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

March 1, 2012 updated by: Roger Williams Medical Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roger Williams Medical Center

Investigators

  • Principal Investigator: Richard P Junghans, PhD, MD, Roger Williams Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

April 1, 2011

Study Registration Dates

First Submitted

January 30, 2007

First Submitted That Met QC Criteria

January 30, 2007

First Posted (ESTIMATE)

January 31, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 2, 2012

Last Update Submitted That Met QC Criteria

March 1, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3020-01A1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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