Sirolimus in Treating Patients With Glioblastoma Multiforme
A Modified Phase I/II Trial Of Rapamycin In Patients With Glioblastoma Multiforme
Sponsor study identifier
Secondary identifiers
interventional
13
1 country
1
Study Start
July 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2005
Actual (reported)Study Completion
October 2007
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2007
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2002
Date type not reportedThis date has not been verified as actual or estimated.
October 3, 2002
Actual (reported)January 27, 2003
Actual (reported)June 2005
Actual (reported)October 2007
Actual (reported)Maximum tolerated dose (for phase 1)
end of phase 1
Efficacy in terms of progression-free survival at 6 months and objective response (phase II)
6 months after last subject finishes trial
Safety Profile (phase I)
end of phase I
Further evaluate safety profile
end of phase II
See intervention description.
See intervention description.
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.
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781, United States
Cloughesy TF, Yoshimoto K, Nghiemphu P, Brown K, Dang J, Zhu S, Hsueh T, Chen Y, Wang W, Youngkin D, Liau L, Martin N, Becker D, Bergsneider M, Lai A, Green R, Oglesby T, Koleto M, Trent J, Horvath S, Mischel PS, Mellinghoff IK, Sawyers CL. Antitumor activity of rapamycin in a Phase I trial for patients with recurrent PTEN-deficient glioblastoma. PLoS Med. 2008 Jan 22;5(1):e8. doi: 10.1371/journal.pmed.0050008.
Timothy F. Cloughesy, MD
Jonsson Comprehensive Cancer Center
13 participants (actual enrollment reported by the registry).
First Submitted
October 3, 2002
First Posted
January 27, 2003
Study Start
July 2002
Date type not reportedThis date has not been verified as actual or estimated.
Surgical resection.
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.
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Primary Completion
June 2005
Actual (reported)Study Completion
October 2007
Actual (reported)Last Updated
August 3, 2020
Record last verified: 2012-07
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Source: ClinicalTrials.gov.
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