Clinical trial · Interventional
Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma
Efficacy of a Protracted Temozolomide Schedule in Patients With Progression After Standard Dose Temozolomide for High-grade Gliomas
NCT00575887CI-TRIAL-00013204completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy of temozolomide on a protracted schedule, after standard 5-day temozolomide regimen in patients with recurrent or progressive high grade glioma.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytoma | Astrocytoma | CURATED_BROADER | 0.80 |
| Brain Tumor, Recurrent | Brain Neoplasm | CURATED_BROADER | 0.78 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Oligodendroglioma | Oligodendroglioma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Temozolomide
Primary outcomes (1)
- measure
- Progression-free Survival at 6-months
- timeFrame
- Until progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient age \>18 years old * Histopathological diagnosis of high grade glioma (anaplastic astrocytoma or anaplastic oligodendroglioma or anaplastic oligoastrocytoma or glioblastoma multiforme) * Progression after standard dose (D1-5/28 days)temozolomide either during recurrence or adjuvant treatment approved in Magnetic Resonance imaging * Karnofsky Performance Status scale \>/=50 (due to brain pathology) * Adequate hematological, renal and hepatic function * Patients willing to participate in the study and signing the informed consent Exclusion Criteria: * Karnofsky Performance Status scale \<50 * Female patients with pregnancy or with suspicion of pregnancy. Patients with fertility will be warned for appropriate contraception during the study * Patients not suitable for follow-up
References
Publications (1)
- RESULTAbacioglu U, Caglar HB, Yumuk PF, Akgun Z, Atasoy BM, Sengoz M. Efficacy of protracted dose-dense temozolomide in patients with recurrent high-grade glioma. J Neurooncol. 2011 Jul;103(3):585-93. doi: 10.1007/s11060-010-0423-2. Epub 2010 Sep 29. PMID 20878446