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Sponsored by: |
Robert H. Lurie Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00348790 |
RATIONALE: Vatalanib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well vatalanib works in treating patients with recurrent or progressive meningioma.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors Sarcoma |
Drug: vatalanib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of PTK-787 in Recurrent or Progressive Meningiomas |
Estimated Enrollment: | 25 |
Study Start Date: | May 2006 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral vatalanib twice daily on days 1-28. Courses repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 1 year.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed meningioma, including the following subtypes:
Malignant meningioma
May or may not have neurofibromatosis (NF) type 1 or 2 disease
Progressive or recurrent disease by MRI or CT scan
Recent resection of recurrent or progressive tumor allowed provided both of the following criteria are met:
PATIENT CHARACTERISTICS:
No severe and/or uncontrolled medical conditions that would limit compliance with study requirements, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, Illinois | |
Hematology-Oncology Associates of Illinois | Recruiting |
Chicago, Illinois, United States, 60611-2998 | |
Contact: Steven B. Newman, MD 312-664-5400 steven.newman@usoncology.com | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Recruiting |
Chicago, Illinois, United States, 60611-3013 | |
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 cancer@northwestern.edu |
Study Chair: | Jeffrey J. Raizer, MD | Robert H. Lurie Cancer Center |
Responsible Party: | Robert H. Lurie Comprehensive Cancer Center at Northwestern University ( Jeffrey J. Raizer ) |
Study ID Numbers: | CDR0000486746, NU-05C4, NU-1398-025, NOVARTIS-NU-05C4 |
Study First Received: | July 5, 2006 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00348790 |
Health Authority: | Unspecified |
adult grade I meningioma adult grade II meningioma adult grade III meningioma adult malignant hemangiopericytoma |
adult anaplastic meningioma adult papillary meningioma adult melanocytic lesion recurrent adult brain tumor |
Brain Neoplasms Meningeal Neoplasms Malignant mesenchymal tumor Sarcoma Meningioma Central Nervous System Neoplasms |
Hemangiopericytoma Soft tissue sarcomas Recurrence Nervous System Neoplasms Vatalanib |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Nervous System Diseases |
Neoplasms, Nerve Tissue Neoplasms, Vascular Tissue Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |