Phase 2 N=25 Treatment

Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma

Glioblastoma · Astrocytoma · Oligodendroglioma · Brain Tumor, Recurrent

Bottom Line

View on ClinicalTrials.gov: NCT00575887 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2013

Primary outcome: Primary: Progression-free Survival at 6-months — 17.3 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Temozolomide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Marmara University
Primary completion: Mar 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression-free Survival at 6-months	17.3	—

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.

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

View full record on ClinicalTrials.gov →

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.