Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase I Study of the Combination of Radiation Therapy (RT), Arsenic Trioxide (ATO) and Temozolomide (TMZ) in Patients With Newly-Diagnosed Glioblastoma Multiforme (GBM)
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in
chemotherapy, such as arsenic trioxide and temozolomide, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Arsenic trioxide and temozolomide may also make tumor cells more sensitive to radiation
therapy. Giving radiation therapy together with combination chemotherapy may kill more tumor
cells.
PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide
when given together with temozolomide and radiation therapy in treating patients with newly
diagnosed high-grade glioma.
OBJECTIVES:
- Determine the maximum tolerated dose of arsenic trioxide when administered sequentially
with temozolomide during radiotherapy in patients with newly diagnosed glioblastoma
multiforme.
- Determine the dose-limiting toxicities of this regimen in these patients.
OUTLINE: This is a dose-escalation study of arsenic trioxide.
Patients undergo radiotherapy (may be intensity-modulated) on days 1-5. Patients also
receive arsenic trioxide IV over 1-2 hours on days 1-5, and oral temozolomide on days 1-7.
Treatment with radiotherapy, arsenic trioxide, and temozolomide repeats every week for up to
6 weeks in the absence of disease progression or unacceptable toxicity.
Patients may then receive oral temozolomide on days 1-5. Treatment repeats every 4 weeks for
up to 12 courses in the absence of disease progression.
After completion of study therapy, patients are followed periodically.
;
Primary Purpose: Treatment
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