drugset / Trial / NCT00200161

Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma

NCT00200161

RandomizedParallel-groupOpen-labelTreatment

Summary

Patients have a newly diagnosed brain tumor called a malignant glioma and participate in the study to see if it is possible to increase the benefit of temozolomide when given after radiation. A recent study showed that patients with newly diagnosed glioblastoma lived longer when treated with both temozolomide and radiotherapy followed by 6 months of temozolomide than patients treated with radiotherapy alone. Patients will receive standard low dose temozolomide during radiation. After radiation, they will be randomized to receive either more intense temozolomide or continuous low dose temozolomide.

Timeline

Start
2005-08-09
Primary completion
2017-05-04
Completion
2017-05-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Temozolomide Small molecule 50 mg/m2
Subject Temozolomide Small molecule 150 mg/m2
Background Isotretinoin Other / unclassified

Indications