Sirolimus in Treating Patients With Glioblastoma Multiforme

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

July 31, 2002

Primary Completion Date

June 30, 2005

Study Completion Date

October 31, 2007

Conditions
Brain and Central Nervous System Tumors
Interventions
DRUG

Rapamycin

"Phase 1: Initial dose 6mg on day 1 and then 2mg each day for 5-7 days before surgery. No dosing during surgery recovery. After recorvery 6mg loading dose on day 1 then 2mg each day. Cycle is every 4 weeks.~Dose escalation: Level 2: 15mg load/5mg/day, Level 3: 30mg load/10mg/day, Level 4: 45mg load/15mg/day.~Phase 2: Will utilize dose established in phase I. Dosing schedule will remain the same."

PROCEDURE

Surgery

Surgical resection.

PROCEDURE

Supportive Care

"Corticosteroids should be used in smallest dose to control symptoms of cerebral edema and mass effect.~Anti-seizure medications should be used as indicated. Febrile neutropenia may be managed according to local institution's infectious disease guidelines.~If neurosurgical management is required for reasons not due to tumor progression, these procedures must be documented."

Trial Locations (1)

90095-1781

Jonsson Comprehensive Cancer Center at UCLA, Los Angeles

All Listed Sponsors
lead

Jonsson Comprehensive Cancer Center

OTHER

NCT00047073 - Sirolimus in Treating Patients With Glioblastoma Multiforme | Biotech Hunter | Biotech Hunter