Status:
COMPLETED
Combination of Hydroxyurea and Verapamil for Refractory Meningiomas
Lead Sponsor:
University of Utah
Conditions:
Cancer
Brain Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 bu...
Detailed Description
The investigators have demonstrated previously that the calcium channel antagonists (CCAs) verapamil, nifedipine, and diltiazem can block in vitro and in vivo meningioma growth at clinically relevant ...
Eligibility Criteria
Inclusion
- Must be age \> 18 years
- Patient able to provide written informed consent
- Histologically confirmed meningioma of any WHO grade (written pathology report from surgery required)
- Radiographic demonstration of at least 25% increase in tumor cross sectional area measured on CT/MRI within last 6 months
- Patients refusing or for which there is no further surgical or radiation therapy options
- WBC at least 2,500/mm3
- Platelet count of at least 100,000/mm3
- Hemoglobin \> 8.0 g/dL
- Renal insufficiency (glomerular filtration rate (GFR) \< 60 as estimated by the Cockcroft-Gault equation) are ineligible
- Hepatic disease (ALT, AST, bilirubin, or alkaline phosphatase \> 3 times upper limit of normal) or known cirrhosis are ineligible
- Clinically significant cardiovascular disease specifically those patients with the following conditions are ineligible:
- congestive heart failure
- known bundle branch or AV conduction problems
- 2nd or 3rd degree atrioventricular block (except in patients with artificial pacemaker),
- sick sinus syndrome
- atrial flutter or atrial fibrillation with an accessory bypass tract (Wolff-Parkinson-White Syndrome, Lown-Ganong-Levine Syndrome),
- history of myocardial infarction in the past 6 months
- currently taking beta-blockers, digoxin, or neuromuscular blocking agents
- Bradycardia (resting heart rate \< 60 beats per minute)
- Hypotension (resting blood pressure \< 90 systolic)
- Altered neuromuscular transmission (Duchenne Muscular Dystrophy, myasthenia gravis)
- Karnofsky performance score 50-100%
- Life expectancy more than 6 months
- Pregnant or nursing females are ineligible. Fertile patients must use an effective contraception
- Received prior investigational agents in the past 6 months are ineligible
Exclusion
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00706810
Start Date
December 1 2007
End Date
September 1 2015
Last Update
April 13 2017
Active Locations (1)
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1
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112