Sirolimus in Treating Patients With Glioblastoma Multiforme

Phase 1

Completed

• Conditions: Brain and Central Nervous System Tumors
• Interventions: Drug: Rapamycin; Procedure: Surgery; Procedure: Supportive Care

• Registration Number: NCT00047073
• Lead Sponsor: Jonsson Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2002-07
• Study First Submitted: 2002-10-03
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2005-06
• Study Completion: 2007-10
• Status Verified: 2012-07
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase 2	Surgery	See intervention description.
Phase 1	Supportive Care	See intervention description.
Phase 1	Surgery	See intervention description.
Phase 2	Supportive Care	See intervention description.
Phase 1	Rapamycin	See intervention description.
Phase 2	Rapamycin	See intervention description.

Primary Outcome Measures

Name	Time	Method
Efficacy in terms of progression-free survival at 6 months and objective response (phase II)	6 months after last subject finishes trial
Maximum tolerated dose (for phase 1)	end of phase 1

Secondary Outcome Measures

Name	Time	Method
Safety Profile (phase I)	end of phase I
Further evaluate safety profile	end of phase II

Trial Locations

Locations (1)

Jonsson Comprehensive Cancer Center at UCLA; 🇺🇸 Los Angeles, California, United States