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Memantine for Recurrent Glioblastoma

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.
 
ClinicalTrials.gov Identifier: NCT01260467
Recruitment Status : Terminated
First Posted : December 15, 2010
Results First Posted : December 10, 2015
Last Update Posted : December 10, 2015
Sponsor:
Information provided by (Responsible Party):
Nimish Mohile, University of Rochester

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Glioblastoma
Intervention Drug: memantine
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Agent Memantine Group
Hide Arm/Group Description memantine:10 milligrams orally twice a day
Period Title: Overall Study
Started 4
Completed 2
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title Single Agent Memantine Group
Hide Arm/Group Description memantine:10 milligrams orally twice a day
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  75.0%
>=65 years
1
  25.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
1
  25.0%
Male
3
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
not evaluated due to poor patient accrual
Arm/Group Title Single Agent Memantine Group
Hide Arm/Group Description:
memantine:10 milligrams orally twice a day
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title 6 Month Progression-free Survival
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
not evaluated due to poor patient accrual
Arm/Group Title Memantine Arm
Hide Arm/Group Description:
memantine: 10 milligrams orally twice a day
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description This study will look at the number of participants who develop adverse events or side effects thought to be related to the memantine.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
Hide Arm/Group Description:
No adverse events reported.
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participants
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Agent Memantine Group
Hide Arm/Group Description NO data to report
All-Cause Mortality
Single Agent Memantine Group
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Single Agent Memantine Group
Affected / at Risk (%)
Total   0/4 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Agent Memantine Group
Affected / at Risk (%)
Total   0/4 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Jennifer Serventi Research Associate
Organization: University of Rochester Medical Center
Phone: 585-276-3971
EMail: jennifer_serventi@urmc.rochester.edu
Layout table for additonal information
Responsible Party: Nimish Mohile, University of Rochester
ClinicalTrials.gov Identifier: NCT01260467    
Other Study ID Numbers: RSRB34285
054835-002 ( Other Grant/Funding Number: American Society of Clinical Oncology )
First Submitted: December 10, 2010
First Posted: December 15, 2010
Results First Submitted: June 19, 2015
Results First Posted: December 10, 2015
Last Update Posted: December 10, 2015