Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Modified Phase I/II Trial Of Rapamycin In Patients With Glioblastoma Multiforme
RATIONALE: Chemotherapy drugs such as sirolimus use different ways to stop tumor cells from
dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink
the tumor so that it can be removed during surgery.
PURPOSE: Phase I/II trial to study the effectiveness of sirolimus in treating patients who
have glioblastoma multiforme that did not respond to previous radiation therapy.
OBJECTIVES:
- Determine the maximum tolerated dose of sirolimus in patients with glioblastoma
multiforme.
- Determine the safety profile of this drug in these patients.
- Determine the efficacy of this drug, in terms of 6-month progression-free survival and
objective response, in these patients.
OUTLINE: This is a dose-escalation study.
- Phase I: Patients receive oral sirolimus for 5-7 days before surgery. Patients then
undergo surgical resection. Patients resume oral sirolimus once daily after full
recovery from surgery. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of sirolimus until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive oral sirolimus as in phase I at the dose determined in that
phase.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 3-12 patients will be accrued for phase I of the study within
3-12 months. A total of 32 patients will be accrued for phase II of the study.
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