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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00561665 |
Purpose
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying sunitinib to see how well it works in treating patients with recurrent or unresectable meningioma, intracranial hemangiopericytoma, or intracranial hemangioblastoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Neurofibromatosis Type 1 Neurofibromatosis Type 2 Precancerous/Nonmalignant Condition |
Drug: sunitinib malate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma |
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2007 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Exploratory
OUTLINE: This is a multicenter study. Patients are stratified according to histology (benign vs malignant) and whether or not they have neurofibromatosis type 2 (yes vs no).
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 1 month and then periodically thereafter.
PROJECTED ACCRUAL: A total of 50 patients (40 patients with meningioma and 10 patients with hemangiopericytomas/hemangioblastomas) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed meningioma or intracranial hemangiopericytoma or hemangioblastoma
Classic radiographic picture of meningioma allowed provided the tumor is not surgically accessible
Patients with malignant meningioma must be on a stable dose of steroids for at least 5 days prior to baseline imaging
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Any of the following within the past 6 months:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
At least 4 weeks since prior standard external beam radiotherapy , interstitial brachytherapy, or radiosurgery in any combination and there must be subsequent evidence of tumor progression
At least 4 weeks since prior radiotherapy, radiosurgery, or chemotherapy
Recent resection for recurrent tumor allowed provide the patient has recovered from the effects of surgery and has residual disease that can be evaluated
CT scan/MRI should be done no later than 96 hours in the immediate postoperative period or at least 4 weeks post-operatively
Exclusion criteria:
Concurrent therapeutic doses of warfarin
Contacts and Locations| 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: Lauren E. Abrey, MD 212-639-5122 abreyl@mskcc.org | |
| United States, Pennsylvania | |
| UPMC Cancer Centers | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073 | |
| United States, Virginia | |
| University of Virginia Cancer Center | Recruiting |
| Charlottesville, Virginia, United States, 22908-0432 | |
| Contact: David Schiff, MD 434-982-4415 | |
| Principal Investigator: | Lauren E. Abrey, MD | Memorial Sloan-Kettering Cancer Center |
| Principal Investigator: | Andrew B. Lassman, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Lauren E. Abrey ) |
| Study ID Numbers: | CDR0000574581, MSKCC-07135, 07-135, PFIZER-MSKCC-07135 |
| Study First Received: | November 20, 2007 |
| Last Updated: | September 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00561665 History of Changes |
| Health Authority: | Unspecified |
|
adult meningioma adult grade I meningioma adult grade II meningioma adult grade III meningioma recurrent adult brain tumor |
adult meningeal hemangiopericytoma neurofibromatosis type 1 neurofibromatosis type 2 precancerous/nonmalignant condition |
|
Vestibulocochlear Nerve Diseases Meningeal Neoplasms Otorhinolaryngologic Neoplasms Precancerous Conditions Neuroma, Acoustic Antineoplastic Agents Physiological Effects of Drugs Retrocochlear Diseases Neoplasms, Nerve Tissue Cranial Nerve Neoplasms Central Nervous System Neoplasms Neurodegenerative Diseases Ear Diseases Neurofibromatosis 1 Neurofibromatosis 2 |
Neoplasms by Site Heredodegenerative Disorders, Nervous System Neurofibroma Neuromuscular Diseases Sunitinib Therapeutic Uses Neoplasms, Germ Cell and Embryonal Neoplasms, Vascular Tissue Meningioma Growth Inhibitors Angiogenesis Modulating Agents Nervous System Neoplasms Neurocutaneous Syndromes Otorhinolaryngologic Diseases Neoplasms by Histologic Type |