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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 (Responsible Party): | 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: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment
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.
Other Names:
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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 | 212-639-5122 | |
| Contact: Andrew Lassman, MD | 212-639-6037 |
| 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 | Active, not recruiting |
| Basking Ridge, New Jersey, United States | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center at Commack | Active, not recruiting |
| Commack, New York, United States, 11725 | |
| Memorial Sloan-Kettering Cancer Center | Active, not recruiting |
| New York, New York, United States, 10065 | |
| 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 | Active, not recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Principal Investigator: | Thomas Kaley, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00589784 History of Changes |
| Other Study ID Numbers: | 07-135 |
| Study First Received: | December 26, 2007 |
| Last Updated: | November 21, 2011 |
| 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 |
|
Hemangiopericytoma Meningioma Neurofibromatoses Central Nervous System Neoplasms Hemangioblastoma Neoplasms, Vascular Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Meningeal Neoplasms Nervous System Neoplasms Neoplasms by Site Nervous System Diseases Neurofibroma Nerve Sheath Neoplasms |
Neoplastic Syndromes, Hereditary Neurocutaneous Syndromes Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Hemangioma, Capillary Hemangioma Sunitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs |