drugset
drugset / Trial / NCT00424554

Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed)

NCT00424554 ↗

Phase 2 Completed 40 enrolled Merck Sharp & Dohme LLC
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this study is to assess the effect of a two-week pre-surgery treatment with low-dose temozolomide (TMZ) on brain tumor methylguanine-DNA (deoxyribonucleic acid) methyltransferase (MGMT) activity in patients with gliomas.

Timeline

Start
2006-09-26
Primary completion
2010-01-11
Completion
2011-02-16

Outcome

Missed primary endpoint

registry Temozolomide (TMZ) vs No Intervention; p = 0.09; t-test, 2 sided NCT00424554 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Temozolomide Small molecule 75 mg/m2 —

Indications

glioma