A Modified Phase I/II Trial Of Rapamycin In Patients With Glioblastoma Multiforme
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Efficacy in terms of progression-free survival at 6 months and objective response (phase II)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Phase 1
See intervention description.
Intervention: Rapamycin (Drug)
Phase 1
See intervention description.
Intervention: Surgery (Procedure)
Phase 1
See intervention description.
Intervention: Supportive Care (Procedure)
Phase 2
See intervention description.
Intervention: Rapamycin (Drug)
Phase 2
See intervention description.
Intervention: Surgery (Procedure)
Phase 2
See intervention description.
Intervention: Supportive Care (Procedure)
Outcomes
Primary Outcomes
Efficacy in terms of progression-free survival at 6 months and objective response (phase II)
Time Frame: 6 months after last subject finishes trial
Maximum tolerated dose (for phase 1)
Time Frame: end of phase 1
Secondary Outcomes
- Safety Profile (phase I)(end of phase I)
- Further evaluate safety profile(end of phase II)