Study Stopped
This study will be incorporated into another study.
Trial of Second Generation Designer T Cells in Colorectal Carcinoma
Phase II/Pilot Trial of Second Generation Designer T Cells in Colorectal Cancer
1 other identifier
interventional
1
1 country
1
Brief Summary
The purpose of this study is to collect data on the safety and effectiveness of 2nd generation designer T cells in patients with colorectal cancer. Designer T cells are prepared by collecting white blood cells from the participant, and then modifying these cells in the laboratory so that they recognize the tumor antigen (CEA). These modified cells are then given back into the participant so that they can attack and kill tumor cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 colorectal-cancer
Started May 2008
Typical duration for phase_1 colorectal-cancer
1 active site
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
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 5, 2008
CompletedFirst Posted
Study publicly available on registry
May 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedJune 17, 2016
June 1, 2016
4.3 years
May 5, 2008
June 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the safety of using modified T cells by documenting the type and severity of any side effects and establishing the Maximum Tolerated Dose (MTD).
1 Month
Secondary Outcomes (3)
Tumor Response
1 Month
Pharmacokinetics
1 Month
Pharmacodynamics
1 Month
Study Arms (1)
Gene Modified T Cells
EXPERIMENTALModified T cells
Interventions
One time infusion Modified T-Cells given through a vein in the arm or a catheter over a 30-60 minute period.
Eligibility Criteria
You may qualify if:
- Must have cancer of the colon or rectum
- Must have metastatic or unresectable locally advanced disease
- Tumor must express CEA by tumor staining or by elevated serum CEA (\>10 ng/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
- Good performance status (PS 0-1)
You may not qualify if:
- Requiring systemic steroids
- Serious medical conditions
- Concurrent malignancies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Roger Williams Medical Center
Providence, Rhode Island, 02908, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard P Junghans, PhD, MD
Roger Williams Medical Center
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
May 5, 2008
First Posted
May 7, 2008
Study Start
May 1, 2008
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
June 17, 2016
Record last verified: 2016-06