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Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00354913 |
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as hydroxyurea, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imatinib mesylate together with hydroxyurea may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving imatinib mesylate together with hydroxyurea works in treating patients with recurrent or progressive meningioma.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: hydroxyurea Drug: imatinib mesylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Imatinib Mesylate Plus Hydroxyurea in the Treatment of Patients With Recurrent/Progressive Meningioma |
Estimated Enrollment: | 21 |
Study Start Date: | August 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label study.
Patients receive oral imatinib mesylate once or twice daily and oral hydroxyurea twice daily on days 1-28.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 21 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:
No evidence of intratumor hemorrhage on pretreatment diagnostic imaging
PATIENT CHARACTERISTICS:
No concurrent severe and/or uncontrolled medical disease, including any of the following:
No impairment of gastrointestinal function or disease that may significantly alter the absorption of imatinib mesylate, including any of the following:
PRIOR CONCURRENT THERAPY:
At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)*
United States, North Carolina | |
Duke Comprehensive Cancer Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Clinical Trials Office - Duke Comprehensive Cancer Center 888-275-3853 |
Study Chair: | David A. Reardon, MD | Duke University |
Study ID Numbers: | CDR0000482393, DUMC-7082-05-4R0, NOVARTIS-DUMC-7082-05-4R0 |
Study First Received: | July 19, 2006 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00354913 History of Changes |
Health Authority: | Unspecified |
adult grade I meningioma adult grade II meningioma adult grade III meningioma |
adult papillary meningioma adult anaplastic meningioma recurrent adult brain tumor |
Imatinib Brain Neoplasms Meningeal Neoplasms Hydroxyurea Meningioma |
Central Nervous System Neoplasms Protein Kinase Inhibitors Recurrence Nervous System Neoplasms |
Meningeal Neoplasms Antisickling Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Hydroxyurea Antineoplastic Agents Hematologic Agents Neoplasms, Nerve Tissue Nervous System Diseases Enzyme Inhibitors Central Nervous System Neoplasms |
Protein Kinase Inhibitors Pharmacologic Actions Imatinib Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Vascular Tissue Meningioma Nucleic Acid Synthesis Inhibitors Nervous System Neoplasms |