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| Sponsor: | University of Utah |
|---|---|
| Information provided by: | University of Utah |
| ClinicalTrials.gov Identifier: | NCT00706810 |
Purpose
Meningiomas account for 20% of primary adult brain tumors, occurring at an annual incidence of 6 per 100,000 (Louis, Scheithauer et al. 2000). Complete surgical resection is the treatment of choice but may not possible when the tumor invades critical structures (e.g., skull base, sagittal sinus) (Mirimanoff, Dosoretz et al. 1985; al-Rodhan and Laws 1990; Al-Rodhan and Laws 1991; Newman 1994; De Monte 1995; Levine, Buchanan et al. 1999; Barnett, Suh et al. 2000; Ragel and Jensen 2003). Up to 20% of meningiomas exhibit a more aggressive phenotype that does not respond to standard therapies (Kyritsis 1996). Adjuvant therapies are critical for patients with this subset of meningiomas. Radiation therapy and stereotactic radiosurgery are good adjuvant therapies but are limited by radiation neurotoxicity, tumor size constraints, and injury to adjacent vascular structures or cranial nerves (Goldsmith, Wara et al. 1994; Barnett, Suh et al. 2000; Goldsmith and Larson 2000). Standard chemotherapeutic treatments have been disappointing (Kyritsis 1996). Even drugs like temozolomide that have shown efficacy against malignant brain tumors have failed to inhibit the growth of refractory meningiomas in a phase II study (Chamberlain, Tsao-Wei et al. 2004).
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer Brain Cancer Meningioma |
Drug: Hydroxyurea Drug: Verapamil |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Combination of Hydroxyurea and Verapamil for Refractory Meningiomas |
| Estimated Enrollment: | 18 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Clinically significant cardiovascular disease specifically those patients with the following conditions are ineligible:
Contacts and Locations| Contact: Travis Ault | 801-587-5562 | travis.ault@hci.utah.edu |
| Contact: Jessica Moehle | 801-587-4438 | jessica.moehle@hci.utah.edu |
| United States, Utah | |
| Huntsman Cancer Institute | Recruiting |
| Salt Lake City, Utah, United States, 84112 | |
| Principal Investigator: Randy Jensen, MD, Ph.D | |
| Principal Investigator: | Randy Jensen, MD, Ph.D. | Huntsman Cancer Institute |
More Information
| Responsible Party: | Huntsman Cancer Institute ( Randy Jensen, MD ) |
| Study ID Numbers: | HCI # 25089 |
| Study First Received: | June 26, 2008 |
| Last Updated: | November 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00706810 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Cancer Brain cancer Meningioma |
|
Meningeal Neoplasms Vasodilator Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hydroxyurea Hematologic Agents Neoplasms, Nerve Tissue Calcium Channel Blockers Central Nervous System Neoplasms Brain Diseases Membrane Transport Modulators Neoplasms by Site Therapeutic Uses Neoplasms, Vascular Tissue Meningioma |
Anti-Arrhythmia Agents Nucleic Acid Synthesis Inhibitors Nervous System Neoplasms Antisickling Agents Neoplasms by Histologic Type Nervous System Diseases Central Nervous System Diseases Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Brain Neoplasms Neoplasms Verapamil Diltiazem |