Gastric CancerPhase 1NCT00429078
Trial of 2nd Generation Anti-CEA Designer T Cells in Gastric Cancer
A Phase 1 study testing 2nd Generation Designer T Cells in people with Gastric Cancer, run by Roger Williams Medical Center.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- 2nd Generation Designer T Cells
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Apr 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior investigational treatment
- Requiring systemic steroids
- Serious medical conditions
- Concurrent malignancies
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- 2nd Generation Designer T Cells
- Keywords
- Gastric Cancer, T Cells, Gene Transfer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2nd Generation Designer T CellsGenetic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2007 (estimated)
- Study startJul 2007
- Primary completionApr 2011
- Study completionApr 2011
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roger Williams Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard P Junghans, PhD, MD, Principal investigator, Roger Williams Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429078
- Sponsor's protocol ID
- 3020-01A1
- Status last verified
- Mar 2012
- First submitted
- 30 Jan 2007
- Last updated
- 2 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of 2nd Generation Anti-CEA Designer T Cells in Gastric Cancer
- ClinicalTrials.gov ID
- NCT00429078
- Acronym / sponsor ID
- 3020-01A1
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, T Cells, Gene Transfer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: low accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Roger Williams Medical CenterUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 31 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Prior investigational treatment
- Requiring systemic steroids
- Serious medical conditions
- Concurrent malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2nd Generation Designer T Cells | Genetic | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard P Junghans, PhD, MD principal investigator
Roger Williams Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 2nd Generation Designer T Cells in people with Gastric Cancer, run by Roger Williams Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2012.