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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborators: |
Dana-Farber Cancer Institute University of Virginia University of Pittsburgh Pfizer |
| Information provided by: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00589784 |
Purpose
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 |
|---|---|---|
|
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: | 50 |
| 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 |
|---|---|
|
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.
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Absolute neutrophil count (ANC) ≥ 1,000/mm3
Exclusion Criteria:
Contacts and Locations| Contact: Thomas Kaley, MD | kaleyt@mskcc.org |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Patrick Wen, MD | |
| Principal Investigator: Patrick Wen, MD | |
| United States, New Jersey | |
| Memoral Sloan Kettering Cancer Center | Recruiting |
| Basking Ridge, New Jersey, United States | |
| Contact: Thomas Kaley, MD kaleyt@mskcc.org | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Thomas Kaley, MD kaleyt@mskcc.org | |
| Memorial Sloan-Kettering Cancer Center at Commack | Recruiting |
| Commack, New York, United States, 11725 | |
| Contact: Thomas Kaley, MD kaleyt@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: | Thomas Kaley, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Thomas Kaley, MD ) |
| Study ID Numbers: | 07-135 |
| Study First Received: | December 26, 2007 |
| Last Updated: | July 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00589784 History of Changes |
| 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 07-135 |
|
Meningeal Neoplasms Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Central Nervous System Neoplasms Neurodegenerative Diseases Neurofibromatosis 1 Neoplasms by Site Heredodegenerative Disorders, Nervous System Neurofibroma Neuromuscular Diseases Sunitinib Therapeutic Uses Neoplasms, Vascular Tissue Hemangioma |
Meningioma Growth Inhibitors Angiogenesis Modulating Agents Nervous System Neoplasms Neurocutaneous Syndromes Neoplasms by Histologic Type Hemangioblastoma Growth Substances Hemangioma, Capillary Nervous System Diseases Angiogenesis Inhibitors Hemangiopericytoma Pharmacologic Actions Neoplasms Neoplastic Syndromes, Hereditary |