Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma

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: NCT00498927
Recruitment Status : Completed
First Posted : July 11, 2007
Results First Posted : February 29, 2016
Last Update Posted : February 29, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Weill Medical College of Cornell University
Schering-Plough
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Brain and Central Nervous System Tumors
Interventions Drug: temozolomide
Genetic: protein expression analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: diagnostic laboratory biomarker analysis
Other: immunoenzyme technique
Enrollment 47
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Temozolomide
Hide Arm/Group Description Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
Period Title: Overall Study
Started 47
Completed 47
Not Completed 0
Arm/Group Title Temozolomide
Hide Arm/Group Description Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
Overall Number of Baseline Participants 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
<=18 years
0
   0.0%
Between 18 and 65 years
36
  76.6%
>=65 years
11
  23.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
Female
16
  34.0%
Male
31
  66.0%
1.Primary Outcome
Title Progression-free Survival (PFS) Rate at 6 Months
Hide Description Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame at 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Glioblastoma patients
Arm/Group Title Temozolomide
Hide Arm/Group Description:
Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
Overall Number of Participants Analyzed 37
Measure Type: Number
Unit of Measure: percentage of participants
19
2.Secondary Outcome
Title Overall Survival
Hide Description All patients will have their tumor measurements recorded at baseline and at the time of each MRI scan. Lesions must be measured in two dimensions. The dose of gadolinium must be held constant from scan to scan. Macdonald criteria will be used for assessment of tumor response.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Glioblastoma patients
Arm/Group Title Temozolomide
Hide Arm/Group Description:
Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
Overall Number of Participants Analyzed 37
Median (95% Confidence Interval)
Unit of Measure: months
7
(5 to 12)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Temozolomide
Hide Arm/Group Description Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
All-Cause Mortality
Temozolomide
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Temozolomide
Affected / at Risk (%) # Events
Total   14/47 (29.79%)    
Blood and lymphatic system disorders   
AST, SGOT  1  1/47 (2.13%)  1
Cardiac disorders   
Thrombosis/thrombus/embolism  1  1/47 (2.13%)  1
Gastrointestinal disorders   
Dehydration  1  1/47 (2.13%)  1
General disorders   
Confusion  1  3/47 (6.38%)  3
Extremity-lower (gait/walking)  1  2/47 (4.26%)  2
Fatigue (asthenia, lethargy, malaise)  1  2/47 (4.26%)  2
Mood alteration - Agitation  1  1/47 (2.13%)  1
Pain - Back  1  1/47 (2.13%)  1
Pain - Head/headache  1  2/47 (4.26%)  2
Seizure  1  2/47 (4.26%)  2
Speech impairment  1  1/47 (2.13%)  1
Infections and infestations   
Infection, other  1  1/47 (2.13%)  1
Nervous system disorders   
CNS cerebrovascular ischemia  1  1/47 (2.13%)  1
Cognitive disturbance  1  1/47 (2.13%)  1
Pyramidal tract dysfunction  1  1/47 (2.13%)  1
Neurology - Other (specify)  1  1/47 (2.13%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Temozolomide
Affected / at Risk (%) # Events
Total   14/47 (29.79%)    
Blood and lymphatic system disorders   
Leukocytes (total WBC)  1  6/47 (12.77%)  6
Lymphopenia  1  7/47 (14.89%)  7
Platelets  1  3/47 (6.38%)  3
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  3/47 (6.38%)  3
Metabolism and nutrition disorders   
Glucose, high (hyperglycemia)  1  7/47 (14.89%)  7
Nervous system disorders   
Neuropathy: sensory  1  3/47 (6.38%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Antonio Omuro
Organization: Memorial Sloan Kettering Cancer Center
Phone: 212 639 7523
EMail: omuroa@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00498927    
Other Study ID Numbers: 07-064
P30CA008748 ( U.S. NIH Grant/Contract )
MSKCC-07064
SPRI-PO5096
First Submitted: July 10, 2007
First Posted: July 11, 2007
Results First Submitted: October 5, 2015
Results First Posted: February 29, 2016
Last Update Posted: February 29, 2016