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Sponsors and Collaborators: |
North American Brain Tumor Consortium National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00112736 |
RATIONALE: Erlotinib and temsirolimus and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I/II trial is studying the side effects and best dose of temsirolimus when given together with erlotinib and to see how well they work in treating patients with recurrent malignant glioma.
Condition | Intervention | Phase |
Brain and Central Nervous System Tumors |
Drug: erlotinib hydrochloride Drug: temsirolimus |
Phase I Phase II |
MedlinePlus related topics: | Cancer |
ChemIDplus related topics: | Erlotinib Erlotinib hydrochloride CCI 779 |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I/II Study of OSI-774 (Erlotinib) and CCI-779 (Temsirolimus) in Patients With Recurrent Malignant Glioma |
Estimated Enrollment: | 74 |
Study Start Date: | April 2005 |
Estimated Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, phase I, dose-escalation study of temsirolimus followed by a phase II study. Patients are stratified according to study phase (I vs II), histology at study enrollment (glioblastoma multiforme or gliosarcoma vs anaplastic glioma), preoperative candidacy (yes vs no), and presence of measurable or evaluable disease (yes vs no).
Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for the phase I portion of the study within 1-8 months. A total of 50 patients (32 patients with glioblastoma multiforme and 18 with anaplastic glioma) will be accrued for the phase II portion of the study within 8-12 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed intracranial malignant glioma of 1 of the following types:
Unequivocal evidence of progressive disease by MRI or CT scan while on a stable dose of steroids for ≥ 5 days
Meets 1 of the following criteria for treatment of prior relapses:
Treated for no more than 2 prior relapses* (phase II patients only)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Prior resection of recurrent or progressive disease allowed provided patient has recovered
Other
United States, California | |||||
Jonsson Comprehensive Cancer Center at UCLA | Recruiting | ||||
Los Angeles, California, United States, 90095-1781 | |||||
Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a 888-798-0719 | |||||
UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting | ||||
San Francisco, California, United States, 94115 | |||||
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |||||
United States, Maryland | |||||
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting | ||||
Bethesda, Maryland, United States, 20892-1182 | |||||
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |||||
United States, Massachusetts | |||||
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Recruiting | ||||
Boston, Massachusetts, United States, 02115 | |||||
Contact: Clinical Trials Office - Dana-Farber/Harvard Cancer Center 617-582-8480 | |||||
United States, New York | |||||
Memorial Sloan-Kettering Cancer Center | Recruiting | ||||
New York, New York, United States, 10021 | |||||
Contact: Lisa M. DeAngelis, MD 212-639-7997 | |||||
United States, North Carolina | |||||
Duke Comprehensive Cancer Center | Recruiting | ||||
Durham, North Carolina, United States, 27710 | |||||
Contact: David A. Reardon, MD 919-668-1409 reard003@mc.duke.edu | |||||
United States, Pennsylvania | |||||
UPMC Cancer Centers | Recruiting | ||||
Pittsburgh, Pennsylvania, United States, 15232 | |||||
Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073 | |||||
United States, Texas | |||||
M. D. Anderson Cancer Center at University of Texas | Recruiting | ||||
Houston, Texas, United States, 77030-4009 | |||||
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 | |||||
University of Texas Health Science Center at San Antonio | Recruiting | ||||
San Antonio, Texas, United States, 78284-6220 | |||||
Contact: John G. Kuhn, Pharm, FCCP 210-567-8355 | |||||
United States, Wisconsin | |||||
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Recruiting | ||||
Madison, Wisconsin, United States, 53792-6164 | |||||
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo 608-262-5223 |
North American Brain Tumor Consortium |
National Cancer Institute (NCI) |
Study Chair: | Patrick Y. Wen, MD | Dana-Farber Cancer Institute |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Web site for additional information 
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Robins HI, Wen PY, Chang SM, et al.: Phase I study of erlotinib and CCI-779 (temsirolimus) for patients with recurrent malignant gliomas (MG) (NABTC 04-02). [Abstract] J Clin Oncol 25 (Suppl 18): A-2057, 2007.
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Study ID Numbers: | CDR0000429553, NABTC-0402, NCI-06-C-0053 |
First Received: | June 2, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00112736 |
Health Authority: | Unspecified |
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