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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center Dana-Farber Cancer Institute University of Virginia University of Pittsburgh Pfizer |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00589784 |
The purpose of this study is to find out what effects, good and/or bad, sunitinib has on patients and their tumors. At this time, no drugs are routinely used to treat meningioma, hemangioblastoma or hemangiopericytoma. Only surgery and radiation therapy are known to be useful.
Sunitinib is a drug approved for advanced kidney cancer. Sunitinib is also being studied for other tumors. It may be useful in the treatment of brain tumors because it can prevent formation of new blood vessels that allow tumor cells to survive and grow.
Condition | Intervention | Phase |
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CNS Cancer Meningioma Intracranial Hemangiopericytoma Hemangioblastoma Neurofibromatosis |
Drug: Sunitinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma |
Estimated Enrollment: | 30 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Treatment: Experimental
Sunitinib will be administered at a dose of 50 mg orally once daily for four consecutive weeks, followed by a two-week rest period. Intra-patient dose reduction may be required depending on the type and severity of individual toxicity encountered. Imaging studies will be performed after every other cycle. Patients may continue on study as long as they are tolerating treatment and in the absence of disease progression.
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Drug: Sunitinib
The study drug will be administered on an outpatient basis. The starting dose will be 50 mg daily for 28 days (4 consecutive weeks) followed by 14 days off for patients not on CYP3A4 inducers or inhibitors. A cycle equals 42 days. Patients on strong CYP3A4 inducers should start at a dose of 62.5 mg and those on strong CYP3A4 inhibitors should start at a dose of 37.5 mg. The dose should be taken once daily at approximately the same time each day. Patients are required to have a drug rest period of at least 14 days after each dosing period. Dosing can be modified after discussion with the study investigator. The study investigator may implement dose suspension or reduction in order to ensure patient safety. Patients will be given a diary to take home to record their sunitinib dosing. |
This is a phase II study of Sunitinib in patients with recurrent or inoperable meningiomas. An exploratory study will be performed for patients with recurrent hemangiopericytoma or hemangioblastoma. There will be approximately 50 patients enrolled on this study (40 meningiomas and 10 hemangiopericytomas/hemangioblastomas). The treatment plan is to use daily SU11248 at a dose of 50 mg, using the established schedule of 4 weeks of treatment followed by two weeks of rest period, forming a six-week treatment cycle. A medical professional will see each patient at least every six weeks while on the medication for toxicity assessment and physical examination. Extent of disease evaluations will occur at baseline, two weeks, twelve weeks, 24 weeks, and every twelve weeks thereafter. These evaluations will include MRI of the brain (or CT head if a patient cannot undergo MRI) and MR perfusion.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lauren Abrey, MD | abreyl@mskcc.org |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Lauren Abrey, MD abreyl@mskcc.org | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburg, Pennsylvania, United States | |
Contact: Frank Liberman, MD, PhD | |
United States, Virginia | |
University of Virginia Health Science Center | Recruiting |
Charlottesville, Virginia, United States, 22908 | |
Contact: David Schiff, MD |
Principal Investigator: | Lauren Abrey, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Lauren Abrey, MD ) |
Study ID Numbers: | 07-135 |
Study First Received: | December 26, 2007 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00589784 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Sunitinib Brain Cancer CNS Cancer meningioma intracranial hemangiopericytoma |
hemangioblastoma malignant meningioma neurofibromatosis neurofibromatosis type 1 neurofibromatosis type 2 |
Meningeal Neoplasms Central Nervous System Neoplasms Neurodegenerative Diseases Neurofibromatosis 1 Neurofibromatosis 2 Heredodegenerative Disorders, Nervous System Neurofibroma Neuromuscular Diseases Sunitinib Hemangioma Meningioma Nervous System Neoplasms Neurocutaneous Syndromes |
Hemangioblastoma Hemangioma, Capillary Hemangiopericytoma Recurrence Neurofibromatosis type 1 Neurofibromatosis type 2 Brain Neoplasms Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Peripheral Nervous System Diseases Neurofibromatoses Nerve Sheath Neoplasms |
Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Nervous System Diseases Physiological Effects of Drugs Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Vascular Tissue Growth Inhibitors Angiogenesis Modulating Agents |