NCT00429078

Brief Summary

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2007

Typical duration for phase_1 gastric-cancer

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

March 2, 2012

Status Verified

March 1, 2012

Enrollment Period

3.8 years

First QC Date

January 30, 2007

Last Update Submit

March 1, 2012

Conditions

Gastric Cancer

Keywords

Gastric CancerT CellsGene Transfer

Interventions

2nd Generation Designer T CellsGENETIC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prior investigational treatment
  • Requiring systemic steroids
  • Serious medical conditions
  • Concurrent malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Richard P Junghans, PhD, MD

    Roger Williams Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2007

First Posted

January 31, 2007

Study Start

July 1, 2007

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

March 2, 2012

Record last verified: 2012-03