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NCT01457131 · ClinicalTrials.gov registry record · Phase 1
Modified White Blood Cells That Secrete IL-2 and Express a Protein That Targets the ESO-1tumor Protein for Metastatic Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT01457131: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01457131 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01457131, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
Background: \- A new cancer treatment involves collecting white blood cells from an individual, modifying them to secrete IL-2 and target the ESO-1 protein expressed on some cancers, and returning them to the body. The cells may then be able to seek out the cancer cells and destroy them. Some kinds of cancer contain a protein called ESO-1, which is found on the surface of the cells. Doctors want to modify white blood cells to have an anti-ESO-1 effect, and use them to treat the cancer that has the ESO-1. In addition to adding genes that target the ESO-1 protein to the cells, the genes for IL-12 are added to the cells. IL-12 is a protein that stimulates the immune system. This type of therapy is called gene transfer. Objectives: \- To test the safety and effectiveness of anti-ESO-1/IL-12 white blood cells against metastatic cancer. Eligibility: \- Individuals at least 18 years of age who have metastatic cancer that expresses ESO-1 and has not responded to standard treatments. Design: * Participants will be screened with a medical history and physical exam. They will also have blood tests and imaging studies. * Participants will have leukapheresis about a month before the treatment to collect white blood cells. * They will have chemotherapy 5 days before the treatment to suppress the immune system, and prepare the body for the anti-ESO-1/IL-12 cells. * The anti-ESO-1/IL-12 cells will be given as an infusion. * Participants will be monitored in the hospital during their recovery from the treatment. * Participants will have regular followup exams every 1 to 6 months. The exams will include blood tests, imaging studies, and other studies. Due to toxicities seen with the regimen, it was decided not to pursue the phase 2 portion of the study.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- OTHER IL-12 & Anti-NY ESO1 TCR PBL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2011-10-06 |
| Est. Completion | 2013-08-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01457131
The ClinicalTrials.gov registry entry for NCT01457131 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 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 3 interventions - of which Cyclophosphamide is the first listed.
NCT01457131 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01457131 about?
NCT01457131 is a clinical study titled "Modified White Blood Cells That Secrete IL-2 and Express a Protein That Targets the ESO-1tumor Protein for Metastatic Cancer". Background: \- A new cancer treatment involves collecting white blood cells from an individual, modifying them to secrete IL-2 and target the ESO-1 protein expressed on some cancers, and returning them to the body. The cells may then be able to seek out the cancer cells and destroy them. Some kinds...
What is the current status of trial NCT01457131?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2011-10-06. Estimated completion is 2013-08-07.
What interventions are being tested in trial NCT01457131?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), IL-12 & Anti-NY ESO1 TCR PBL (OTHER).
Who is sponsoring clinical trial NCT01457131?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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