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Sponsors and Collaborators: |
Adult Brain Tumor Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00335764 |
RATIONALE: Sorafenib, erlotinib, tipifarnib, and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Sorafenib and tipifarnib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with erlotinib, tipifarnib, or temsirolimus may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib, tipifarnib, and temsirolimus when given together with sorafenib and to see how well they work in treating patients with recurrent glioblastoma multiforme or gliosarcoma.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: erlotinib hydrochloride Drug: sorafenib tosylate Drug: temsirolimus Drug: tipifarnib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I/II Studies of BAY 43-9006 (Sorafenib) in Combination With OSI-774 (Erlotinib), R115777 (Tipifarnib) or CCI-779 (Temsirolimus) in Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma |
Estimated Enrollment: | 183 |
Study Start Date: | April 2006 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Experimental
Patients receive oral sorafenib twice daily and oral erlotinib hydrochloride once daily on days 1-28.
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Drug: erlotinib hydrochloride
Given orally
Drug: sorafenib tosylate
Given orally
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Group 2: Experimental
Patients receive sorafenib as in group 1. Patients also receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
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Drug: sorafenib tosylate
Given orally
Drug: temsirolimus
Given IV
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Group 3: Experimental
Patients receive sorafenib as in group 1. Patients also receive oral tipifarnib twice daily on days 1-21.
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Drug: sorafenib tosylate
Given orally
Drug: tipifarnib
Given orally
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Evidence of tumor progression by MRI or CT scan within the past 14 days AND on a steroid dose that has been stable for ≥ 5 days
Recent resection of recurrent or progressive tumor allowed
No more than 3 prior therapies (initial therapy and therapy for 2 relapses) (phase II)
Each of the following is considered 1 relapse:
PATIENT CHARACTERISTICS:
PT/INR ≤ 1.5 (INR < 3.0 for patients on anticoagulation therapy)
PRIOR CONCURRENT THERAPY:
No other concurrent CYP3A4 inducers (e.g., rifampin or Hypericum perforatum [St. John's wort])
Full-dose anticoagulants allowed provided both of the following criteria are met:
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: Patrick Y. Wen, MD 617-632-2166 patrick_wen@dfci.harvard.edu | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Lisa M. DeAngelis, MD 212-639-7997 | |
United States, North Carolina | |
Duke Comprehensive Cancer Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Clinical Trials Office - Duke Comprehensive Cancer Center 888-275-3853 | |
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 |
Study Chair: | Mark R. Gilbert, MD | M.D. Anderson Cancer Center |
Responsible Party: | North American Brain Tumor Consortium ( Michael Prados ) |
Study ID Numbers: | CDR0000476286, ABTC-05-02, NABTC-05-02 |
Study First Received: | June 8, 2006 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00335764 History of Changes |
Health Authority: | Unspecified |
adult giant cell glioblastoma adult glioblastoma adult gliosarcoma recurrent adult brain tumor |
Erlotinib Glioblastoma Astrocytoma Central Nervous System Neoplasms Protein Kinase Inhibitors Recurrence Brain Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Glioma Glioblastoma Multiforme Gliosarcoma Sorafenib Nervous System Neoplasms Tipifarnib Neoplasms, Glandular and Epithelial |
Erlotinib Glioblastoma Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Astrocytoma Antineoplastic Agents Nervous System Diseases Neoplasms, Nerve Tissue Enzyme Inhibitors Central Nervous System Neoplasms Protein Kinase Inhibitors Pharmacologic Actions |
Neuroectodermal Tumors Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Glioma Gliosarcoma Neoplasms, Neuroepithelial Sorafenib Nervous System Neoplasms Tipifarnib Neoplasms, Glandular and Epithelial |