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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

  Participant Flow

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
Aggressive Memingioma Patients with Aggressive Memingioma
Exploratory Cohort Patients with WHO grade I meningioma, HPC and hemangioblastoma

Participant Flow:   Overall Study
    Aggressive Memingioma   Exploratory Cohort
STARTED   36   14 
COMPLETED   35   4 
NOT COMPLETED   1   10 
Withdrawal by Subject                0                6 
Patient inevaluable                1                0 
Adverse Event                0                4 



  Baseline Characteristics

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
Aggressive Memingioma Patients with Aggressive Memingioma
Exploratory Cohort Patients with WHO grade I meningioma, HPC and hemangioblastoma
Total Total of all reporting groups

Baseline Measures
   Aggressive Memingioma   Exploratory Cohort   Total 
Overall Participants Analyzed 
[Units: Participants]
 36   13   49 
Age, Customized 
[Units: Years]
Median (Full Range)
     
Median Age   61 
 (27 to 85) 
 48 
 (32 to 79) 
 59 
 (27 to 85) 
Gender 
[Units: Participants]
     
Female   14   5   19 
Male   22   8   30 


  Outcome Measures

1.  Primary:   Overall Objective Response   [ Time Frame: 1.5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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
e-mail: KaleyT@mskcc.org



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