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NCT00924287 · ClinicalTrials.gov registry record · Phase 1
Gene Therapy Using Anti-Her-2 Cells to Treat Metastatic Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT00924287: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00924287 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 1 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00924287, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
Background: * Human epidermal growth factor receptor-2 (Her-2) is a gene found in both normal cells and cancer cells. Extra copies of the gene (overexpression) can cause too many Her-2 proteins (receptors) to appear on the cell surface and cause tumors to grow. * An experimental procedure developed for treating patients with cancer uses blood cells found in their tumors or bloodstream. The cells are genetically modified using the anti-Her-2 gene and a type of virus. The modified cells (anti-Her-2 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 overexpress Her-2 can be treated effectively with lymphocytes (white blood cells) that have been genetically engineered to contain an anti-Her-2 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. * Patient's tumor overexpresses Her-2. Design: * Workup with scans, x-rays and other tests. * Leukapheresis to obtain cells for preparing the anti-Her-2 cells for later infusion. * 1 week of chemotherapy to prepare the immune system for receiving the anti-Her-2 cells. * Infusion of anti-Her-2 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. * 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 Cyclophosphamide
- DRUG Fludarabine
- DRUG Mesna
- DRUG in vitro tumor reactive, chimeric T cell receptor (CAR ) gene-transduced PBL plus IV aldesleukin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2008-11 |
| Est. Completion | 2010-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00924287
The ClinicalTrials.gov registry entry for NCT00924287 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 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 4 interventions - of which Cyclophosphamide is the first listed.
NCT00924287 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00924287 about?
NCT00924287 is a clinical study titled "Gene Therapy Using Anti-Her-2 Cells to Treat Metastatic Cancer". Background: * Human epidermal growth factor receptor-2 (Her-2) is a gene found in both normal cells and cancer cells. Extra copies of the gene (overexpression) can cause too many Her-2 proteins (receptors) to appear on the cell surface and cause tumors to grow. * An experimental procedure developed...
What is the current status of trial NCT00924287?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2008-11. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00924287?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Mesna (DRUG), in vitro tumor reactive, chimeric T cell receptor (CAR ) gene-transduced PBL plus IV aldesleukin (DRUG).
Who is sponsoring clinical trial NCT00924287?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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