A Randomized Phase II Trial of Concurrent Temozolomide and Radiotherapy Followed by Dose Dense Versus Metronomic Temozolomide and Maintenance Cis-Retinoic Acid for Patients With Newly Diagnosed Glioblastoma and Other Malignant Gliomas
This is a randomized phase II study that will test two different adjuvant temozolomide
regimens in patients with newly diagnosed glioblastoma multiforme. The goal of this study
is to identify a regimen that would be appropriate to bring to a phase III trial and compare
to the standard dosing regimen of temozolomide recently reported by Stupp et al. in the New
England Journal of Medicine. Secondary goals of this study include: prospective analysis of
the prognostic impact of MGMT status and generation of preliminary data regarding this
treatment strategy for other types of malignant glioma.
The decision regarding which treatment patients receive is made randomly. Neither them or
their doctor can select which treatment the patient will receive. There is reason to believe
that both of these doses may benefit treating your brain tumor. After 6 months of
chemotherapy, and assuming the brain tumor has not shown any sign of growth, they will begin
receiving cis-retinoic acid. Cis retinoic acid has been shown in one study to possibly
prevent or delay tumor recurrence.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the overall survival of patients with newly diagnosed glioblastoma multiforme treated with concurrent temozolomide and radiotherapy followed by dose dense or metronomic dosing of temozolomide and maintenance cis-retinoic acid.
until death or date of last follow up
Lisa DeAngelis, M.D
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Memorial Sloan-Kettering Cancer Center at Commack||Commack, New York 11725|
|Memorial Sloan-Kettering at Basking Ridge||Basking Ridge, New Jersey 07920|