|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | University of California, Los Angeles |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00047073 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: Rapamycin Procedure: Surgery Procedure: Supportive Care |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Modified Phase I/II Trial Of Rapamycin In Patients With Glioblastoma Multiforme |
| Enrollment: | 13 |
| Study Start Date: | July 2002 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Phase 1: Experimental
See intervention description.
|
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.
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. |
|
Phase 2: Experimental
See intervention description.
|
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.
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. |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Disease progression by MRI or CT scan
Phase I patients:
Phase II patients:
Recent resection of recurrent or progressive tumor allowed as long as all of the following conditions apply:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Principal Investigator: | Timothy F. Cloughesy, MD | Jonsson Comprehensive Cancer Center |
More Information
| Responsible Party: | UCLA ( Timothy Cloughesy, M.D. ) |
| Study ID Numbers: | CDR0000257255, P30CA016042, UCLA-0203078, NCI-G02-2114 |
| Study First Received: | October 3, 2002 |
| Last Updated: | December 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00047073 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent adult brain tumor adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
|
Sirolimus Glioblastoma Anti-Infective Agents Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Central Nervous System Neoplasms Antibiotics, Antineoplastic Anti-Bacterial Agents Neoplasms by Site Neoplasms, Germ Cell and Embryonal Therapeutic Uses |
Antifungal Agents Glioma Nervous System Neoplasms Neoplasms by Histologic Type Astrocytoma Nervous System Diseases Immunosuppressive Agents Pharmacologic Actions Neuroectodermal Tumors Neoplasms Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial |