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Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma

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ClinicalTrials.gov Identifier: NCT00589784
Recruitment Status : Completed
First Posted : January 10, 2008
Results First Posted : January 25, 2016
Last Update Posted : January 25, 2016
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
University of Virginia
University of Pittsburgh
Pfizer
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions CNS Cancer
Meningioma
Intracranial Hemangiopericytoma
Hemangioblastoma
Neurofibromatosis
Intervention Drug: Sunitinib
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aggressive Memingioma Exploratory Cohort
Hide Arm/Group Description Patients with Aggressive Memingioma Patients with WHO grade I meningioma, HPC and hemangioblastoma
Period Title: Overall Study
Started 36 14
Completed 35 4
Not Completed 1 10
Reason Not Completed
Withdrawal by Subject             0             6
Patient inevaluable             1             0
Adverse Event             0             4
Arm/Group Title Aggressive Memingioma Exploratory Cohort Total
Hide Arm/Group Description Patients with Aggressive Memingioma Patients with WHO grade I meningioma, HPC and hemangioblastoma Total of all reporting groups
Overall Number of Baseline Participants 36 13 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Median Age Number Analyzed 36 participants 13 participants 49 participants
61
(27 to 85)
48
(32 to 79)
59
(27 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 13 participants 49 participants
Female
14
  38.9%
5
  38.5%
19
  38.8%
Male
22
  61.1%
8
  61.5%
30
  61.2%
1.Primary Outcome
Title Overall Objective Response
Hide Description Determine the overall objective response
Time Frame 1.5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aggressive Memingioma Exploratory Cohort
Hide Arm/Group Description:
Patients with Aggressive Memingioma
Patients with WHO grade I meningioma, HPC and hemangioblastoma
Overall Number of Participants Analyzed 35 4
Measure Type: Number
Unit of Measure: participants
Complete Response 1 0
Partial Response 1 0
Progression of Disease 8 4
Stable Disease 25 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Patients
Hide Arm/Group Description All patients treated with Sunitinib (SU011248)
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Patients
Affected / at Risk (%) # Events
Total   27/50 (54.00%)    
Blood and lymphatic system disorders   
Neutropenia  1  4/50 (8.00%)  4
Lymphopenia  1  5/50 (10.00%)  5
Lueukopenia  1  3/50 (6.00%)  3
ALT  1  2/50 (4.00%)  2
AST  1  2/50 (4.00%)  2
Cardiac disorders   
Hypertension  1  4/50 (8.00%)  4
Prolonged QTc Interval  1  1/50 (2.00%)  1
Right Ventricular Enlargement  1  1/50 (2.00%)  1
Gastrointestinal disorders   
Dehydration  1  2/50 (4.00%)  2
Vomiting  1  2/50 (4.00%)  2
Pancreatitis  1  1/50 (2.00%)  1
Diarrhea  1  1/50 (2.00%)  1
Gastrointestinal Perforation  1  1/50 (2.00%)  1
General disorders   
Fatigue  1  9/50 (18.00%)  9
Headache  1  4/50 (8.00%)  4
Pain  1  2/50 (4.00%)  2
Metabolism and nutrition disorders   
Hypophosphatemia  1  2/50 (4.00%)  2
Hyperglycemia  1  2/50 (4.00%)  2
Hypocalcemia  1  1/50 (2.00%)  1
Creatinine  1  1/50 (2.00%)  1
Hypomagnesemia  1  1/50 (2.00%)  1
Nervous system disorders   
CNS Hemorrhage  1  4/50 (8.00%)  4
Confusion  1  1/50 (2.00%)  1
Renal and urinary disorders   
Hyperuricemia  1  1/50 (2.00%)  1
Respiratory, thoracic and mediastinal disorders   
Thrombic Microangiopathy  1  2/50 (4.00%)  2
Thrombocytopenia  1  6/50 (12.00%)  6
Thrombosis/ Embolism  1  1/50 (2.00%)  1
Skin and subcutaneous tissue disorders   
Rash, Hand-Foot Reaction  1  2/50 (4.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Patients
Affected / at Risk (%) # Events
Total   50/50 (100.00%)    
Blood and lymphatic system disorders   
Leukopenia  1  31/50 (62.00%)  31
AST  1  19/50 (38.00%)  19
ALT  1  17/50 (34.00%)  17
Neutropenia  1  13/50 (26.00%)  13
Cardiac disorders   
Hypertension  1  11/50 (22.00%)  11
Gastrointestinal disorders   
Diarrhea  1  22/50 (44.00%)  22
Nausea  1  17/50 (34.00%)  17
Vomiting  1  12/50 (24.00%)  12
General disorders   
Fatigue  1  29/50 (58.00%)  29
Mucositis  1  13/50 (26.00%)  13
Dysgeusia  1  13/50 (26.00%)  13
Headache  1  12/50 (24.00%)  12
Metabolism and nutrition disorders   
Hypoalbuminemia  1  19/50 (38.00%)  19
Hyperglycemia  1  16/50 (32.00%)  16
Respiratory, thoracic and mediastinal disorders   
Thrombocytopenia  1  23/50 (46.00%)  23
Skin and subcutaneous tissue disorders   
Rash, Hand-Foot Reaction  1  16/50 (32.00%)  16
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Thomas Kaley
Organization: Memorial Sloan Kettering Cancer Center
Phone: 212-639-5122
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00589784     History of Changes
Obsolete Identifiers: NCT00561665
Other Study ID Numbers: 07-135
First Submitted: December 26, 2007
First Posted: January 10, 2008
Results First Submitted: December 21, 2015
Results First Posted: January 25, 2016
Last Update Posted: January 25, 2016