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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00047073 |
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.
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
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 |
Study ID Numbers: | CDR0000257255, UCLA-0203078, NCI-G02-2114 |
Study First Received: | October 3, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00047073 |
Health Authority: | United States: Federal Government |
recurrent adult brain tumor adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Sirolimus Glioblastoma Astrocytoma Clotrimazole Miconazole Tioconazole Central Nervous System Neoplasms Recurrence Brain Neoplasms |
Neuroectodermal Tumors Glioblastoma multiforme Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Nervous System Diseases Antibiotics, Antineoplastic |
Immunosuppressive Agents Pharmacologic Actions Anti-Bacterial Agents Neoplasms Neoplasms by Site Therapeutic Uses Antifungal Agents Neoplasms, Neuroepithelial |