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NCT00508456 · ClinicalTrials.gov registry record · Phase 1
Dietary Methionine Restriction Plus Temozolomide for Recurrent GBM
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT00508456: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00508456 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 18 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00508456, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
Objectives: 1. To determine the safety, tolerability and efficacy of dietary methionine restriction for 7 days alternating with Temodar® (Temozolomide) given once a day for seven days and this repeated for up to one year in the treatment of patients with recurrent and/or progressive glioblastoma. 2. To determine the short- and long-term toxicity of dietary methionine restriction combined with Temodar® in glioblastoma patients. 3. To measure and correlate patients' tumor responses and progression-free survival with: serum methionine and peripheral blood lymphocyte methylation levels. In any patient undergoing surgery, to measure tumor alkylguanyl transferase (AGT) and methionine levels and compare to control specimens.
Interventions
- DRUG Temodar (Temozolomide)
- DIETARY_SUPPLEMENT Hominex-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2004-08 |
| Est. Completion | 2008-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00508456
The ClinicalTrials.gov registry entry for NCT00508456 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Temodar (Temozolomide) is the first listed.
NCT00508456 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00508456 about?
NCT00508456 is a clinical study titled "Dietary Methionine Restriction Plus Temozolomide for Recurrent GBM". Objectives: 1. To determine the safety, tolerability and efficacy of dietary methionine restriction for 7 days alternating with Temodar® (Temozolomide) given once a day for seven days and this repeated for up to one year in the treatment of patients with recurrent and/or progressive glioblastoma. 2...
What is the current status of trial NCT00508456?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2004-08. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00508456?
The interventions under investigation include: Temodar (Temozolomide) (DRUG), Hominex-2 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00508456?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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