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NCT00923390 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 Study of Metastatic Renal Cancer Using T-Cells Transduced With a T-Cell Receptor Which Recognizes TRAIL Bound to the DR4 Receptor
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT00923390: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00923390 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00923390, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
Background: * An experimental cancer treatment procedure involves taking a patient s own tumor or blood cells, modifying them with a gene that targets proteins on the surface of tumor cells, and growing those cells in a laboratory. The modified cells are then given back to the patient by intravenous (IV) transfusion, in the hope that the new cells will attack and destroy the cancer cells without harming healthy tissue. * This procedure has been used for melanoma patients, and researchers are now attempting to use this treatment for patients with renal (kidney) cancer. In the laboratory, this attack kills nearly all kidney cancers tested, but not normal tissues. However, the effectiveness and possible side effects of this treatment are still being studied. Objectives: * To find out if cells modified to target DR4 and TRAIL (two proteins found on the surface of many kidney tumors) are effective in treating kidney cancer. * To determine the maximum tolerated dose (the highest dose that does not cause unacceptable side effects) of the modified cells. Eligibility: * Patients 18 years of age and older with metastatic renal cancer whose disease has not responded to standard treatment. * Patients will be divided into two study branches: Arm A for those who will be receiving modified cells from their biopsied tumor, and Arm B for those who will be receiving their own modified white blood cells. Design: * Five-stage treatment process, outpatient for stages 1 and 5 and inpatient for stages 2 through 4: * Work-up (1 to 2 weeks): Physical examination, heart and lung function tests, imaging tests, blood and/or tumor samples taken. * IV chemotherapy (1 week): Cyclophosphamide and fludarabine to prepare for the new cell infusion. * IV cell infusion and treatment with IL-2 to support the modified cells (4 days). * Recovery (1 to 2 weeks): Recover from effects of chemotherapy and infusion. * Follow-up (every 1 to 6 months): Return to clinic for physical exam, review of side ef
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Aldesleukin
- GENETIC 2G-1 TCR Retroviral Vector-Transduced lyn
- DRUG (PG13-A(F/K-F-SGSG-T2a-B (opt) (2G-1 TCR) retroviral vector-transduced lymphocyte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2009-03-02 |
| Est. Completion | 2012-08-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00923390
The ClinicalTrials.gov registry entry for NCT00923390 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 5 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 5 interventions - of which Cyclophosphamide is the first listed.
NCT00923390 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00923390 about?
NCT00923390 is a clinical study titled "Phase 1/2 Study of Metastatic Renal Cancer Using T-Cells Transduced With a T-Cell Receptor Which Recognizes TRAIL Bound to the DR4 Receptor". Background: * An experimental cancer treatment procedure involves taking a patient s own tumor or blood cells, modifying them with a gene that targets proteins on the surface of tumor cells, and growing those cells in a laboratory. The modified cells are then given back to the patient by intravenou...
What is the current status of trial NCT00923390?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2009-03-02. Estimated completion is 2012-08-24.
What interventions are being tested in trial NCT00923390?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Aldesleukin (DRUG), 2G-1 TCR Retroviral Vector-Transduced lyn (GENETIC), (PG13-A(F/K-F-SGSG-T2a-B (opt) (2G-1 TCR) retroviral vector-transduced lymphocyte (DRUG).
Who is sponsoring clinical trial NCT00923390?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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