Spots Global Cancer Trial Database for Sirolimus in Treating Patients With Glioblastoma Multiforme

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial