Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00412542 · ClinicalTrials.gov registry record · Phase 2
Thalidomide and Temozolomide or Camptothecin-11 (CPT-11) in Patients With Gliomas
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
NCT00412542: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00412542 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 78 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00412542, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
Study Summary
Objectives: 1.1 To determine the efficacy, as measured by 6 month progression-free survival, of therapy with thalidomide combined with CPT-11 in the treatment of patients with recurrent and/or progressive malignant gliomas. 1.2 To determine the rate of measureable clinical response in patients treated with Thalidomide and CPT-11. 1.3 To determine Thrombotic thrombocytopenic purpura (TTP), overall survival and unexpected toxicity of Thalidomide and CPT-11 used in recurrent malignant gliomas. 1.4 To determine changes in dynamic magnetic resonance imaging (MRI) as a surrogate marker for treatment effect.
Primary Outcome
Progression-free Survival (PFS) measured as number of participants that are alive and progression-free at 6 months.
Interventions
- PROCEDURE MRI Scan
- DRUG Thalidomide
- DRUG CPT-11
- PROCEDURE Quantitative Sensory Tests (QST)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2003-10 |
| Est. Completion | 2009-10 |
| Phase | Phase 2 |
What the finished NCT00412542 record still lists
NCT00412542 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 4 interventions - of which MRI Scan is the first listed.
NCT00412542 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00412542 about?
NCT00412542 is a clinical study titled "Thalidomide and Temozolomide or Camptothecin-11 (CPT-11) in Patients With Gliomas". Objectives: 1.1 To determine the efficacy, as measured by 6 month progression-free survival, of therapy with thalidomide combined with CPT-11 in the treatment of patients with recurrent and/or progressive malignant gliomas. 1.2 To determine the rate of measureable clinical response in patients tre...
What is the current status of trial NCT00412542?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2003-10. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00412542?
The interventions under investigation include: MRI Scan (PROCEDURE), Thalidomide (DRUG), CPT-11 (DRUG), Quantitative Sensory Tests (QST) (PROCEDURE).
Who is sponsoring clinical trial NCT00412542?
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 NCT00412542's enrollment target sits among peer trials
78 884th of 2000 higher than 1,110 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02397668 · 78 participants · NA
CorMatrix Cor TRICUSPID ECM Valve Replacement Study
- NCT03321656 · 78 participants · Phase 2
Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
- NCT03687814 · 78 participants · NA
Low FODMAP Plus PEG 3350 for the Treatment of Patients with Irritable Bowel Syndrome-Constipation
- NCT04018872 · 78 participants · Phase 2
Evaluating the Effect of Itraconazole on Pathologic Complete Response Rates in Esophageal Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia