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Combination of Hydroxyurea and Verapamil for Refractory Meningiomas

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00706810
First Posted: June 30, 2008
Last Update Posted: April 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Utah
Results First Submitted: October 12, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Cancer
Brain Cancer
Meningioma
Interventions: Drug: Hydroxyurea
Drug: Verapamil

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
All Participants

Hydroxyurea: Hydroxyurea inhibits DNA synthesis by inhibition of ribonucleotide diphosphate reductase and is a well-known drug used for the treatment of a number of tumor types including head and neck tumors and chronic myelogenous leukemia. It has also been used as an adjuvant for antiretroviral treatment for patients with HIV and as a treatment for polycythemia vera, essential thrombocythemia and sickle cell disease.

Verapamil: Verapamil is another commonly used medication. It is used for the treatment of angina, hypertension, supraventricular arrhythmias, and migraine prophylaxis. Dosing with standard verapamil is 80-120 mg pox three times a day but the sustained release form can be given 120-480mg once or twice each day.


Participant Flow:   Overall Study
    All Participants
STARTED   8 
COMPLETED   7 
NOT COMPLETED   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Groups No text entered.

Baseline Measures
   All Groups 
Overall Participants Analyzed 
[Units: Participants]
 7 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      4  57.1% 
>=65 years      3  42.9% 
Age 
[Units: Years]
Mean (Full Range)
 50 
 (25 to 76) 
Sex/Gender, Customized 
[Units: Participants]
 
Female   6 
Male   1 
Region of Enrollment 
[Units: Participants]
 
United States   7 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Experiencing Serious Adverse Events Including But Not Limited to Hospitalizations, Deaths Related to Treatment, or Other Incapacitating Conditions.   [ Time Frame: two years ]

2.  Secondary:   Median Progression-free Survival Rates of the Treatment Population.   [ Time Frame: 31 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Randy Jensen
Organization: Huntsman Cancer Institute
phone: 801-581-6908
e-mail: randy.jensen@hci.utah.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00706810     History of Changes
Other Study ID Numbers: HCI25089
First Submitted: June 26, 2008
First Posted: June 30, 2008
Results First Submitted: October 12, 2016
Results First Posted: April 13, 2017
Last Update Posted: April 13, 2017