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NCT00657267 · ClinicalTrials.gov registry record · Phase 2
Dose-Intense Temozolomide in Recurrent Glioblastoma
A Phase 2 study, sponsored by Patrick Y. Wen, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
NCT00657267: Completed Phase 2 study, sponsored by Patrick Y. Wen, MD.
NCT00657267 is a Phase 2 study that has completed, run by Patrick Y. Wen, MD. The registered enrollment target is 58 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00657267, a Phase 2 study, has completed, sponsored by Patrick Y. Wen, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
Study Summary
Temozolomide (Temodar) is an FDA approved medication for the treatment of newly diagnosed glioblastomas. In this study, we will be using temozolomide to treat recurrent glioblastomas. We will be using a different dose and schedule than the FDA approved dose and schedule. The purpose of this study is to determine if patients that have failed standard temozolomide treatment will respond to temozolomide when given at a different dose and schedule (21 days every 28 days).
Primary Outcome
Progression is defined using Modified Macdonald Criteria , using a \>/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Interventions
- DRUG Temozolomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2008-05 |
| Est. Completion | 2013-10 |
| Phase | Phase 2 |
What the finished NCT00657267 record still lists
NCT00657267 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 1 intervention - of which Temozolomide is the first listed.
NCT00657267 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00657267 about?
NCT00657267 is a clinical study titled "Dose-Intense Temozolomide in Recurrent Glioblastoma". Temozolomide (Temodar) is an FDA approved medication for the treatment of newly diagnosed glioblastomas. In this study, we will be using temozolomide to treat recurrent glioblastomas. We will be using a different dose and schedule than the FDA approved dose and schedule. The purpose of this study is...
What is the current status of trial NCT00657267?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2008-05. Estimated completion is 2013-10.
What interventions are being tested in trial NCT00657267?
The interventions under investigation include: Temozolomide (DRUG).
Who is sponsoring clinical trial NCT00657267?
This trial is sponsored by Patrick Y. Wen, MD, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00657267's enrollment target sits among peer trials
58 1135th of 2000 higher than 860 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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