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Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed 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: NCT00782756
Recruitment Status : Completed
First Posted : October 31, 2008
Results First Posted : February 6, 2018
Last Update Posted : February 6, 2018
Sponsor:
Collaborators:
Genentech, Inc.
National Institutes of Health (NIH)
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 Brain Cancer
Malignant Glioma
Intervention Other: radiotherapy (RT) in combination with temozolomide and bevacizumab
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title RT, With Temozolomide and Bevacizumab
Hide Arm/Group Description

This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.

Bevacizumab10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (Cycle defined as 28 days). Temozolomide 75mg/m2 daily beginning on day 1 through completion of radiotherapy. Hypofractionated dose painting IMRT will start on day 1 and will be delivered on a Monday, Wednesday, Friday schedule for a total of 6 fractions.

Period Title: Overall Study
Started 40
Completed 40
Not Completed 0
Arm/Group Title RT, With Temozolomide and Bevacizumab
Hide Arm/Group Description

This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.

Bevacizumab10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (Cycle defined as 28 days). Temozolomide 75mg/m2 daily beginning on day 1 through completion of radiotherapy. Hypofractionated dose painting IMRT will start on day 1 and will be delivered on a Monday, Wednesday, Friday schedule for a total of 6 fractions.

Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants
55
(18 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
14
  35.0%
Male
26
  65.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
40
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   2.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
36
  90.0%
More than one race
0
   0.0%
Unknown or Not Reported
3
   7.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 40 participants
40
 100.0%
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description Safety assessments and toxicity grading will follow CTCAE Version 4 Grade
Time Frame through study completion, an average of 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RT, With Temozolomide and Bevacizumab
Hide Arm/Group Description:

This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.

Bevacizumab10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (Cycle defined as 28 days). Temozolomide 75mg/m2 daily beginning on day 1 through completion of radiotherapy. Hypofractionated dose painting IMRT will start on day 1 and will be delivered on a Monday, Wednesday, Friday schedule for a total of 6 fractions.

Overall Number of Participants Analyzed 40
Measure Type: Count of Participants
Unit of Measure: Participants
40
 100.0%
2.Secondary Outcome
Title Progression Free Survival
Hide Description [Not Specified]
Time Frame through study completion, an average of 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RT, With Temozolomide and Bevacizumab
Hide Arm/Group Description:

This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.

Bevacizumab10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (Cycle defined as 28 days). Temozolomide 75mg/m2 daily beginning on day 1 through completion of radiotherapy. Hypofractionated dose painting IMRT will start on day 1 and will be delivered on a Monday, Wednesday, Friday schedule for a total of 6 fractions.

Overall Number of Participants Analyzed 40
Median (Full Range)
Unit of Measure: months
10
(8 to 11)
3.Secondary Outcome
Title Neurocognitive Outcome
Hide Description [Not Specified]
Time Frame through study completion, an average of 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
37 participants agreed to undergo neuropsychological evaluations.
Arm/Group Title RT, With Temozolomide and Bevacizumab
Hide Arm/Group Description:

This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.

Bevacizumab10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (Cycle defined as 28 days). Temozolomide 75mg/m2 daily beginning on day 1 through completion of radiotherapy. Hypofractionated dose painting IMRT will start on day 1 and will be delivered on a Monday, Wednesday, Friday schedule for a total of 6 fractions.

Overall Number of Participants Analyzed 40
Measure Type: Count of Participants
Unit of Measure: Participants
Neuropsychological evaluations
37
  92.5%
Did not agree to neuropsychological evaluations
3
   7.5%
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RT, With Temozolomide and Bevacizumab
Hide Arm/Group Description This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.
All-Cause Mortality
RT, With Temozolomide and Bevacizumab
Affected / at Risk (%)
Total   40/40 (100.00%) 
Hide Serious Adverse Events
RT, With Temozolomide and Bevacizumab
Affected / at Risk (%)
Total   19/40 (47.50%) 
Blood and lymphatic system disorders   
Hemoglobin   1/40 (2.50%) 
Leukocytes (total WBC)   1/40 (2.50%) 
Thrombotic microangiopathy   3/40 (7.50%) 
Eye disorders   
Ocular/Visual - Other (specify)   1/40 (2.50%) 
Gastrointestinal disorders   
Colitis   1/40 (2.50%) 
Nausea   3/40 (7.50%) 
Pain - Abdomen NOS   1/40 (2.50%) 
Vomiting   3/40 (7.50%) 
Infections and infestations   
Infection, other   2/40 (5.00%) 
Investigations   
Creatinine   2/40 (5.00%) 
Neutrophils/granulocytes (ANC/AGC)   2/40 (5.00%) 
Platelets   6/40 (15.00%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness - Left-sided   1/40 (2.50%) 
Pain - Back   1/40 (2.50%) 
Nervous system disorders   
Hemorrhage, CNS   1/40 (2.50%) 
Pain - Head/headache   2/40 (5.00%) 
Pyramidal tract dysfunction   2/40 (5.00%) 
Seizure   13/40 (32.50%) 
Speech impairment   2/40 (5.00%) 
Vasovagal episode   1/40 (2.50%) 
Psychiatric disorders   
Confusion   1/40 (2.50%) 
Personality/behavioral   1/40 (2.50%) 
Renal and urinary disorders   
Glomerular filtration rate   1/40 (2.50%) 
Vascular disorders   
Thrombosis/thrombus/embolism   3/40 (7.50%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RT, With Temozolomide and Bevacizumab
Affected / at Risk (%)
Total   40/40 (100.00%) 
Eye disorders   
Vision-blurred vision   2/40 (5.00%) 
Gastrointestinal disorders   
Constipation   18/40 (45.00%) 
Nausea   15/40 (37.50%) 
Diarrhea   6/40 (15.00%) 
Mucositis oral   12/40 (30.00%) 
Vomiting   4/40 (10.00%) 
Hemorrhage, Oral cavity   2/40 (5.00%) 
General disorders   
Fatigue   29/40 (72.50%) 
Injury, poisoning and procedural complications   
Hemorrhage/Bleeding - other   4/40 (10.00%) 
Wound complication, non-infectious   2/40 (5.00%) 
Investigations   
Leukocytes (total WBC)   3/40 (7.50%) 
Neutrophils/granulocytes (ANC/AGC)   2/40 (5.00%) 
Platelets   2/40 (5.00%) 
Metabolism and nutrition disorders   
Anorexia   7/40 (17.50%) 
Musculoskeletal and connective tissue disorders   
Pain - Joint   3/40 (7.50%) 
Pain - neck   2/40 (5.00%) 
Nervous system disorders   
Headache   10/40 (25.00%) 
Neuropathy - sensory   3/40 (7.50%) 
Dizziness   2/40 (5.00%) 
Memory Impairment   2/40 (5.00%) 
Seizure   2/40 (5.00%) 
Renal and urinary disorders   
Proteinuria   2/40 (5.00%) 
Urinary frequency/urgency   2/40 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea   3/40 (7.50%) 
Hemorrhage, Nose   2/40 (5.00%) 
Skin and subcutaneous tissue disorders   
Dermatology/Skin, other   3/40 (7.50%) 
Dry Skin   2/40 (5.00%) 
Rash/desquamation   2/40 (5.00%) 
Vascular disorders   
Hypertension   4/40 (10.00%) 
Thrombosis/thrombus/embolism   2/40 (5.00%) 
Indicates events were collected by systematic assessment
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. Philip Gutin
Organization: Memorial Sloan Kettering Cancer Center
Phone: 212-639-8556
EMail: gutinp@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00782756    
Other Study ID Numbers: 08-126
First Submitted: October 29, 2008
First Posted: October 31, 2008
Results First Submitted: December 13, 2017
Results First Posted: February 6, 2018
Last Update Posted: February 6, 2018