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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). 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.
Primary Outcome
Time to progression measured from the first day of treatment until progression is documented.
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 |
Why NCT00508456 stopped before completion
NCT00508456 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Temodar (Temozolomide) is the first listed.
NCT00508456 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00508456's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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