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RT, Temozolomide, and Bevacizumab Followed by Bevacizumab/Everolimus in First-line Treatment of GBM

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: NCT00805961
Recruitment Status : Completed
First Posted : December 10, 2008
Results First Posted : September 21, 2012
Last Update Posted : August 28, 2013
Sponsor:
Collaborators:
Genentech, Inc.
Novartis
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Glioblastoma Multiforme
Interventions Radiation: Radiation therapy
Drug: Temozolomide
Drug: Bevacizumab
Drug: Everolimus
Enrollment 68
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Overall Study
Hide Arm/Group Description Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
Period Title: Modality Therapy
Started 68
Completed 64
Not Completed 4
Reason Not Completed
Withdrawal by Subject             1
Adverse Event             1
Disease Progression             2
Period Title: Treatment-Free Interval
Started 64
Completed 57
Not Completed 7
Reason Not Completed
Adverse Event             3
Intercurrent Illness             2
Physician Decision             1
Lack of Efficacy             1
Period Title: Maintenance Treatment
Started 57
Completed 23
Not Completed 34
Reason Not Completed
Lack of Efficacy             13
Intercurrent Illness             7
Adverse Event             6
Withdrawal by Subject             5
Symptomatic Deterioration             2
Withdrawn Consent             1
Arm/Group Title Overall Study
Hide Arm/Group Description Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
Overall Number of Baseline Participants 68
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 68 participants
59
(24 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
Female
29
  42.6%
Male
39
  57.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 68 participants
68
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description [Not Specified]
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study
Hide Arm/Group Description:
Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
Overall Number of Participants Analyzed 51
Median (95% Confidence Interval)
Unit of Measure: Months
11.3
(9.3 to 13.1)
2.Secondary Outcome
Title To Assess the Toxicity of This Novel Multimodality Regimen
Hide Description [Not Specified]
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Information provided in the AEs section
Arm/Group Title Overall Study
Hide Arm/Group Description:
Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title To Assess the Overall Survival of Patients With Glioblastoma Multiforme Following Treatment With This Novel Multimodality Regimen
Hide Description [Not Specified]
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study
Hide Arm/Group Description:
Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
Overall Number of Participants Analyzed 68
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Months
13.9 [1] 
(12.4 to NA)
[1]
At time of data analysis of 18 months, some patients were still alive making complete data collection to generate complete confidence interval.
4.Secondary Outcome
Title To Assess the Complete Response Rate of Patients With Glioblastoma Multiforme Following Treatment With This Novel Multimodality Regimen
Hide Description [Not Specified]
Time Frame 18 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Overall Study
Hide Arm/Group Description Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
All-Cause Mortality
Overall Study
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Overall Study
Affected / at Risk (%) # Events
Total   32/68 (47.06%)    
Blood and lymphatic system disorders   
Thrombotic Microangiopathy  1 [1]  1/68 (1.47%)  1
CNS Hemorrhage  1  1/68 (1.47%)  1
Severe Epistaxis with Hematesis  1  1/68 (1.47%)  1
Cardiac disorders   
Myocardial Infarction  1  1/68 (1.47%)  1
Gastrointestinal disorders   
Dehydration  1  1/68 (1.47%)  1
General disorders   
Fatigue  1  2/68 (2.94%)  2
Fever in absence of neutropenia  1  1/68 (1.47%)  2
Death  1  2/68 (2.94%)  2
Pain  1  2/68 (2.94%)  3
Hepatobiliary disorders   
Cholecystitis  1  1/68 (1.47%)  1
Infections and infestations   
Pneumonia  1  3/68 (4.41%)  4
Infection with Unknown ANC  1  1/68 (1.47%)  1
Infection with Normal ANC  1  2/68 (2.94%)  2
Febrile Neutropenia  1  1/68 (1.47%)  1
Infection - Cellulitis  1 [2]  1/68 (1.47%)  1
Infection - Urinary Tract Infection  1  1/68 (1.47%)  1
Metabolism and nutrition disorders   
Hyperglycemia  1  1/68 (1.47%)  1
Musculoskeletal and connective tissue disorders   
Necrotizing Fasciitis  1  1/68 (1.47%)  1
Rhabdomyolysis  1  1/68 (1.47%)  1
Nervous system disorders   
Seizure  1  6/68 (8.82%)  7
Cognitive Disturbance  1  1/68 (1.47%)  1
Neuropathy - Motor  1  1/68 (1.47%)  1
Somnolence  1  1/68 (1.47%)  1
CNS Ischemia  1  2/68 (2.94%)  2
Syncope  1  1/68 (1.47%)  1
Dizziness  1  1/68 (1.47%)  1
Mental Status  1  1/68 (1.47%)  1
Confusion  1  1/68 (1.47%)  1
Neurology - Other  1 [3]  1/68 (1.47%)  1
Renal and urinary disorders   
Renal Failure  1  1/68 (1.47%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  2/68 (2.94%)  2
Pneumonitis  1  3/68 (4.41%)  3
Surgical and medical procedures   
Pneumothorax  1  1/68 (1.47%)  1
Vascular disorders   
Thrombosis/Thrombus/Embolism  1  10/68 (14.71%)  11
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Thrombotic Thrombocytopenic Purpura (TTP)
[2]
Herpes Orbital Cellulitis
[3]
Progressive Glioblastoma Multiforme
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Overall Study
Affected / at Risk (%) # Events
Total   53/68 (77.94%)    
Blood and lymphatic system disorders   
Neutropenia  1 [1]  4/57 (7.02%)  4
Thrombocytopenia  1 [2]  11/68 (16.18%)  11
Thrombocytopenia  1 [1]  10/57 (17.54%)  10
Cardiac disorders   
Hypertension  1 [2]  4/68 (5.88%)  4
Hypertension  1 [1]  22/57 (38.60%)  22
Gastrointestinal disorders   
Nausea/Vomiting  1 [2]  8/68 (11.76%)  8
Stomatitis/Mucositis  1 [2]  7/68 (10.29%)  7
Stomatitis/Mucositis  1 [1]  7/57 (12.28%)  7
Diarrhea  1 [1]  4/57 (7.02%)  4
Nausea/Vomiting  1 [1]  3/57 (5.26%)  3
General disorders   
Fatigue  1 [2]  19/68 (27.94%)  19
Fatigue  1 [1]  27/57 (47.37%)  27
Hyperlipidemia  1 [1]  5/57 (8.77%)  5
Renal and urinary disorders   
Proteinuria  1 [1]  11/57 (19.30%)  11
Respiratory, thoracic and mediastinal disorders   
Pneumonitis  1 [1]  5/57 (8.77%)  5
Skin and subcutaneous tissue disorders   
Rash  1 [2]  4/68 (5.88%)  4
Rash  1 [1]  9/57 (15.79%)  9
Vascular disorders   
Thrombosis/Embolism  1 [1]  8/57 (14.04%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Maintenance Treatment
[2]
Modality Treatment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John D. Hainsworth, MD.
Organization: Sarah Cannon Research Institute
Phone: 877-691-7274
EMail: ASKSARAH@scresearch.net
Layout table for additonal information
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00805961    
Other Study ID Numbers: SCRI CNS 10
First Submitted: December 9, 2008
First Posted: December 10, 2008
Results First Submitted: August 22, 2012
Results First Posted: September 21, 2012
Last Update Posted: August 28, 2013