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Bevacizumab and Carmustine in Treating Patients With Relapsed or Progressive High-Grade Glioma

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ClinicalTrials.gov Identifier: NCT00795665
Recruitment Status : Completed
First Posted : November 21, 2008
Results First Posted : May 12, 2020
Last Update Posted : May 12, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Genentech, Inc.
Information provided by (Responsible Party):
University of California, Davis

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Glioma
Interventions Drug: bevacizumab
Drug: carmustine
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bevacizumab and Carmustine
Hide Arm/Group Description

bevacizumab: Bevacizumab (10 mg/kg) will be given intravenously every other week starting one week before the first dose of BCNU. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.

carmustine: BCNU (200 mg/m2), will be given over 4 hours as a continuous intravenous infusion every 8 weeks. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.

Period Title: Overall Study
Started 7
Completed 7
Not Completed 0
Arm/Group Title Bevacizumab and Carmustine
Hide Arm/Group Description

bevacizumab: Bevacizumab (10 mg/kg) will be given intravenously every other week starting one week before the first dose of BCNU. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.

carmustine: BCNU (200 mg/m2), will be given over 4 hours as a continuous intravenous infusion every 8 weeks. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.

Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
  71.4%
>=65 years
2
  28.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
56  (17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
4
  57.1%
Male
3
  42.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
 100.0%
1.Primary Outcome
Title Progression-free Survival
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 Time from first day of treatment to the first observation of disease progression or death due to any cause (up to 7 years).
Hide Outcome Measure Data
Hide Analysis Population Description
Procedure for fusing PET and MRI images could not be performed; as such the volumetrics of areas of tumor versus cerebral edema could not be analyzed or interpreted, therefore, no data can be reported.
Arm/Group Title Bevacizumab and Carmustine
Hide Arm/Group Description:

bevacizumab: Bevacizumab (10 mg/kg) will be given intravenously every other week starting one week before the first dose of BCNU. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.

carmustine: BCNU (200 mg/m2), will be given over 4 hours as a continuous intravenous infusion every 8 weeks. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Radiographic Response to Therapy
Hide Description Response measured using MRI and PET with image fusion
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
Procedure for fusing PET and MRI images could not be performed; as such the volumetrics of areas of tumor versus cerebral edema could not be analyzed or interpreted, therefore, no data can be reported.
Arm/Group Title Bevacizumab and Carmustine
Hide Arm/Group Description:

bevacizumab: Bevacizumab (10 mg/kg) will be given intravenously every other week starting one week before the first dose of BCNU. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.

carmustine: BCNU (200 mg/m2), will be given over 4 hours as a continuous intravenous infusion every 8 weeks. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Differentiate a Radiographic Response Due to Tumor Shrinkage From a Radiographic Response Due to Decreased Vasogenic Edema
Hide Description Measurements made by novel brain imaging
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
Procedure for fusing PET and MRI images could not be performed; as such the volumetrics of areas of tumor versus cerebral edema could not be analyzed or interpreted, therefore, no data can be reported.
Arm/Group Title Bevacizumab and Carmustine
Hide Arm/Group Description:

bevacizumab: Bevacizumab (10 mg/kg) will be given intravenously every other week starting one week before the first dose of BCNU. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.

carmustine: BCNU (200 mg/m2), will be given over 4 hours as a continuous intravenous infusion every 8 weeks. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Safety and Toxicity
Hide Description Subjects will be assessed clinically for toxicity prior to, during, and after each infusion. NCI CTCAE 3.0 Common Terminology Criteria (CTC) for Adverse Events for toxicity and Adverse Event Reporting will be utilized.
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
Procedure for fusing PET and MRI images could not be performed; as such the volumetrics of areas of tumor versus cerebral edema could not be analyzed or interpreted, therefore, no data can be reported.
Arm/Group Title Bevacizumab and Carmustine
Hide Arm/Group Description:

bevacizumab: Bevacizumab (10 mg/kg) will be given intravenously every other week starting one week before the first dose of BCNU. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.

carmustine: BCNU (200 mg/m2), will be given over 4 hours as a continuous intravenous infusion every 8 weeks. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame Time from first day of treatment to time of death due to any cause (up to 7 years).
Hide Outcome Measure Data
Hide Analysis Population Description
Procedure for fusing PET and MRI images could not be performed; as such the volumetrics of areas of tumor versus cerebral edema could not be analyzed or interpreted, therefore, no data can be reported.
Arm/Group Title Bevacizumab and Carmustine
Hide Arm/Group Description:

bevacizumab: Bevacizumab (10 mg/kg) will be given intravenously every other week starting one week before the first dose of BCNU. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.

carmustine: BCNU (200 mg/m2), will be given over 4 hours as a continuous intravenous infusion every 8 weeks. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 36 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bevacizumab and Carmustine
Hide Arm/Group Description

bevacizumab: Bevacizumab (10 mg/kg) will be given intravenously every other week starting one week before the first dose of BCNU. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.

carmustine: BCNU (200 mg/m2), will be given over 4 hours as a continuous intravenous infusion every 8 weeks. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.

All-Cause Mortality
Bevacizumab and Carmustine
Affected / at Risk (%)
Total   0/7 (0.00%) 
Hide Serious Adverse Events
Bevacizumab and Carmustine
Affected / at Risk (%)
Total   0/7 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bevacizumab and Carmustine
Affected / at Risk (%)
Total   7/7 (100.00%) 
Blood and lymphatic system disorders   
Edema limbs  1  2/7 (28.57%) 
Hemoglobin  1  4/7 (57.14%) 
Hemoglobin decreased  1  1/7 (14.29%) 
Hemorrhage - subconjunctival  1  1/7 (14.29%) 
Hemorrhage nasal  1  1/7 (14.29%) 
Leukocytes  1  4/7 (57.14%) 
Leukopenia  1  1/7 (14.29%) 
Lymphopenia  1  4/7 (57.14%) 
Neutrophils  1  4/7 (57.14%) 
Platelet count decreased  1  1/7 (14.29%) 
Platelets  1  5/7 (71.43%) 
Cardiac disorders   
Hypertension  1  2/7 (28.57%) 
Gastrointestinal disorders   
Nausea  1  1/7 (14.29%) 
General disorders   
Fatigue  1  3/7 (42.86%) 
Flu-like syndrome  1  1/7 (14.29%) 
Infections and infestations   
Pneumonia  1  1/7 (14.29%) 
Urinary tract infection  1  2/7 (28.57%) 
Metabolism and nutrition disorders   
Alanine aminotransferase increased  1  3/7 (42.86%) 
Alkaline phosphatase increased  1  2/7 (28.57%) 
Aspartate aminotransferase increased  1  2/7 (28.57%) 
Hyperbilirubinemia  1  1/7 (14.29%) 
Hypokalemia  1  1/7 (14.29%) 
Infection - Other (Ear Abscess)  1  1/7 (14.29%) 
Infection - Other (Urinary Tract, NOS)  1  1/7 (14.29%) 
Proteinuria  1  1/7 (14.29%) 
Musculoskeletal and connective tissue disorders   
Joint pain  1  1/7 (14.29%) 
Pain in extremity  1  1/7 (14.29%) 
Pain in extremity (arm)  1  1/7 (14.29%) 
Nervous system disorders   
Ischemia cerebrovascular  1  1/7 (14.29%) 
Renal and urinary disorders   
Cystitis  1  2/7 (28.57%) 
Skin and subcutaneous tissue disorders   
Hyperpigmentation  1  1/7 (14.29%) 
Vascular disorders   
Thrombosis/thrombus/embolism  1  1/7 (14.29%) 
1
Term from vocabulary, CTCAE (Unspecified)
Indicates events were collected by systematic assessment
The PI has indicated that data were uninterpretable for the outcome measures in this study.
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: Analyst
Organization: University of California Davis
Phone: 916-734-8053
EMail: nlogihara@ucdavis.eduu
Layout table for additonal information
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00795665    
Other Study ID Numbers: 224865
UCDCC#208 ( Other Identifier: UC Davis )
P30CA093373 ( U.S. NIH Grant/Contract )
First Submitted: November 20, 2008
First Posted: November 21, 2008
Results First Submitted: July 3, 2018
Results First Posted: May 12, 2020
Last Update Posted: May 12, 2020