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| Sponsor: | Jonsson Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| 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: sirolimus Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Modified Phase I/II Trial Of Rapamycin In Patients With Glioblastoma Multiforme |
| Estimated Enrollment: | 44 |
| Study Start Date: | July 2002 |
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 | |
| Study Chair: | Timothy F. Cloughesy, MD | Jonsson Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000257255, UCLA-0203078, NCI-G02-2114 |
| Study First Received: | October 3, 2002 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00047073 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |