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Imatinib Mesylate and Hydroxyurea in Treating Patients With Recurrent or Progressive Meningioma

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ClinicalTrials.gov Identifier: NCT00354913
Recruitment Status : Completed
First Posted : July 20, 2006
Results First Posted : January 14, 2013
Last Update Posted : January 18, 2013
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Glioblastoma
Gliosarcoma
Interventions Drug: hydroxyurea
Drug: imatinib mesylate
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Imatinib Mesylate+Hydroxyurea
Hide Arm/Group Description All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
Period Title: Overall Study
Started 21
Completed 21
Not Completed 0
Arm/Group Title Imatinib Mesylate+Hydroxyurea
Hide Arm/Group Description All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants
54.0  (13.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
12
  57.1%
Male
9
  42.9%
1.Primary Outcome
Title Progression-free Survival at 6 Months
Hide Description Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or death due to any cause.
Time Frame From the date of study treatment initiation to the date of the first documented progression or death from any cause, whichever came first, assessed up to 69 months. For each participant, PFS was assessed at 6 months after treatment initiation.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Imatinib Mesylate+Hydroxyurea
Hide Arm/Group Description:
All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
Overall Number of Participants Analyzed 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
61.9
(38.1 to 78.8)
2.Secondary Outcome
Title Median Progression-free Survival (PFS)
Hide Description Time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.
Time Frame From the date of study treatment initiation to the date of the first documented progression or death from any cause, whichever came first, assessed up to 69 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Imatinib Mesylate+Hydroxyurea
Hide Arm/Group Description:
All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
Overall Number of Participants Analyzed 21
Median (95% Confidence Interval)
Unit of Measure: months
7
(3.8 to 9.2)
3.Secondary Outcome
Title Median Overall Survival (OS)
Hide Description Time in months from the start of study treatment to date of death due to any cause. Patients alive at last follow-up are censored as of that follow-up date. Median OS was estimated using a Kaplan-Meier curve.
Time Frame From the date of study treatment initiation to the date of death from any cause, assessed up to 69 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Imatinib Mesylate+Hydroxyurea
Hide Arm/Group Description:
All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
Overall Number of Participants Analyzed 21
Median (95% Confidence Interval)
Unit of Measure: months
66
(20.7 to 66)
4.Secondary Outcome
Title Objective Response Rate
Hide Description Percentage of participants with an objective response (complete response or partial response). Per modified Macdonald criteria and assessed by MRI, complete response (CR) was the disappearance of all target lesions and partial response (PR) was a ≥50% decrease in the sum of the longest diameter of target lesions. Objective response = CR+PR.
Time Frame 69 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Imatinib Mesylate+Hydroxyurea
Hide Arm/Group Description:
All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: percentage of participants
0
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse Events were gathered in Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 and converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov
 
Arm/Group Title Imatinib Mesylate+Hydroxyurea
Hide Arm/Group Description All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
All-Cause Mortality
Imatinib Mesylate+Hydroxyurea
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Imatinib Mesylate+Hydroxyurea
Affected / at Risk (%)
Total   1/21 (4.76%) 
Infections and infestations   
Sepsis  1  1/21 (4.76%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Imatinib Mesylate+Hydroxyurea
Affected / at Risk (%)
Total   15/21 (71.43%) 
Blood and lymphatic system disorders   
Anemia  1  5/21 (23.81%) 
Eye disorders   
Blurred Vision  1  4/21 (19.05%) 
Extraocular muscle paresis  1  1/21 (4.76%) 
Eye disorders-Other, Inflammation: right eye  1  1/21 (4.76%) 
Eye pain  1  1/21 (4.76%) 
Vitreous hemorrhage  1  1/21 (4.76%) 
Gastrointestinal disorders   
Abdominal distension  1  1/21 (4.76%) 
Constipation  1  3/21 (14.29%) 
Diarrhea  1  2/21 (9.52%) 
Gastrointestinal disorders-Other: increased Appetite  1  1/21 (4.76%) 
Hemorrhoids  1  1/21 (4.76%) 
Mucositis oral  1  1/21 (4.76%) 
Nausea  1  5/21 (23.81%) 
Rectal hemorrhage  1  1/21 (4.76%) 
Vomiting  1  2/21 (9.52%) 
General disorders   
Edema limbs  1  2/21 (9.52%) 
Fatigue  1  4/21 (19.05%) 
Non-cardiac chest pain  1  1/21 (4.76%) 
Infections and infestations   
Infections and infestations-Other: ear drainage  1  1/21 (4.76%) 
Sinusitis  1  1/21 (4.76%) 
Upper respiratory infection  1  1/21 (4.76%) 
Investigations   
Investigations-Other: BUN, high  1  1/21 (4.76%) 
Neutrophil count decreased  1  4/21 (19.05%) 
Platelet count decreased  1  3/21 (14.29%) 
Weight gain  1  1/21 (4.76%) 
White blood count decreased  1  3/21 (14.29%) 
Metabolism and nutrition disorders   
Hyperglycemia  1  2/21 (9.52%) 
Hypernatremia  1  1/21 (4.76%) 
Hypoalbuminemia  1  1/21 (4.76%) 
Hypocalcemia  1  1/21 (4.76%) 
Hypokalemia  1  1/21 (4.76%) 
Hyponatremia  1  1/21 (4.76%) 
Hypophosphatemia  1  1/21 (4.76%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  1/21 (4.76%) 
Pain in extremity  1  2/21 (9.52%) 
Nervous system disorders   
Ataxia  1  2/21 (9.52%) 
Cognitive disturbance  1  1/21 (4.76%) 
Depressed level of consciousness  1  1/21 (4.76%) 
Dizziness  1  3/21 (14.29%) 
Dysphasia  1  2/21 (9.52%) 
Headache  1  3/21 (14.29%) 
Memory impairment  1  3/21 (14.29%) 
Nervous systems disorders-Other: gait  1  1/21 (4.76%) 
Nervous system disorders-Other: Mood Alteration NOS  1  1/21 (4.76%) 
Peripheral motor neuropathy  1  2/21 (9.52%) 
Peripheral sensory neuropathy  1  1/21 (4.76%) 
Pyramidal tract syndrome  1  2/21 (9.52%) 
Psychiatric disorders   
Agitation  1  1/21 (4.76%) 
Confusion  1  1/21 (4.76%) 
Insomnia  1  3/21 (14.29%) 
Psychosis  1  1/21 (4.76%) 
Renal and urinary disorders   
Renal and urinary disorders-Other: nocturia  1  1/21 (4.76%) 
Reproductive system and breast disorders   
Reproductive system and breast disorders-Other: NOS  1  1/21 (4.76%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/21 (4.76%) 
Skin and subcutaneous tissue disorders   
Rash maculo-papular  1  1/21 (4.76%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Annick Desjardins
Organization: Duke University Medical Center
Phone: 919-681-1691
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00354913     History of Changes
Obsolete Identifiers: NCT00611234
Other Study ID Numbers: Pro00006768
DUMC-7082-05-4R0
NOVARTIS-DUMC-7082-05-4R0
First Submitted: July 19, 2006
First Posted: July 20, 2006
Results First Submitted: December 7, 2012
Results First Posted: January 14, 2013
Last Update Posted: January 18, 2013