Phase 2
Completed N=25
Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma
Source: ClinicalTrials.gov NCT00575887 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcomePrimary: Progression-free Survival at 6-months — 17.3 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival at 6-months |
17.3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00575887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.