Glioblastoma Clinical Trial
Official title:
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
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.
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.
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