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NCT00923806 · ClinicalTrials.gov registry record · Phase 1
Gene Therapy Using Anti-CEA Cells to Treat Metastatic Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT00923806: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00923806 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00923806, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
Background: * Carcinoembryonic antigen (CEA) is a protein present mostly in cancer cells. * An experimental procedure developed for treating patients with cancer uses blood cells found in their tumors or bloodstream. These cells are genetically modified using the anti-CEA gene and a type of virus. The modified cells (anti-CEA cells) are grown in the laboratory and then given back to the patient to try to decrease the size of the tumors. This is called gene therapy. Objectives: * To determine whether advanced cancers that that express the CEA antigen can be treated effectively with lymphocytes (white blood cells) that have been genetically engineered to contain an anti-CEA protein. Eligibility: * Patients 18 years of age and older with metastatic cancer (cancer that has spread beyond the original site) and for whom standard treatments are not effective. * Patients' tumors express the CEA antigen. * Patients have the human leukocyte (HLA-A\*0201) antigen. Design: * Workup with scans, x-rays and other tests. * Leukapheresis to obtain cells for preparing the anti-CEA cells for later infusion. * 1 week of chemotherapy to prepare the immune system for receiving the anti-CEA cells. * Infusion of anti-CEA cells, followed by interleukin-2 (IL-2) treatment. The cells are given as an infusion through a vein. IL-2 is given as a 15-minute infusion through a vein every 8 hours for a maximum of 15 doses. * 1-2 weeks of recovery from the effects of chemotherapy and IL-2. * Periodic follow-up clinic visits after hospital discharge for physical examination, review of treatment side effects, laboratory tests and scans every 1 to 6 months.
Interventions
- DRUG Aldesleukin
- BIOLOGICAL PG13-CEA_TCR (Anti-CEA TCR PBL)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2008-12 |
| Est. Completion | 2011-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00923806
The ClinicalTrials.gov registry entry for NCT00923806 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Aldesleukin is the first listed.
NCT00923806 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00923806 about?
NCT00923806 is a clinical study titled "Gene Therapy Using Anti-CEA Cells to Treat Metastatic Cancer". Background: * Carcinoembryonic antigen (CEA) is a protein present mostly in cancer cells. * An experimental procedure developed for treating patients with cancer uses blood cells found in their tumors or bloodstream. These cells are genetically modified using the anti-CEA gene and a type of virus. ...
What is the current status of trial NCT00923806?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2008-12. Estimated completion is 2011-11.
What interventions are being tested in trial NCT00923806?
The interventions under investigation include: Aldesleukin (DRUG), PG13-CEA_TCR (Anti-CEA TCR PBL) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00923806?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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