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
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as carmustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with carmustine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with carmustine works in treating patients with relapsed or progressive high-grade glioma.
|Condition or disease||Intervention/treatment||Phase|
|Glioma||Drug: bevacizumab Drug: carmustine||Phase 2|
- To determine the 6-month progression-free survival of patients with relapsed or progressive high-grade gliomas treated with bevacizumab and carmustine.
- To evaluate the radiographic response to this regimen as measured by MRI and PET scan with image fusion.
- To utilize novel brain imaging to differentiate between a radiographic response due to tumor shrinkage and a radiographic response due to decreased vasogenic edema.
- To evaluate the safety and toxicity of this regimen in these patients.
- To evaluate the overall survival of these patients.
OUTLINE: Patients receive bevacizumab IV on days -7, 8, 22, 36, and 50 of course 1 and on days 8, 22, 36, and 50 of all subsequent courses. Patients also receive carmustine IV over 4 hours on day 1. Treatment repeats every 56 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Bevacizumab (Avastin) and BCNU for Treatment of Relapsed, High Grade Gliomas|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
|Experimental: Bevacizumab and Carmustine||
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.
Other Name: Avastin
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.
Other Name: BCNU
- Progression-free Survival [ 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). ]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.
- Radiographic Response to Therapy [ Time Frame: One year ]Response measured using MRI and PET with image fusion
- Differentiate a Radiographic Response Due to Tumor Shrinkage From a Radiographic Response Due to Decreased Vasogenic Edema [ Time Frame: One year ]Measurements made by novel brain imaging
- Safety and Toxicity [ Time Frame: One year ]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.
- Overall Survival [ Time Frame: Time from first day of treatment to time of death due to any cause (up to 7 years). ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795665
|United States, California|
|University of California Davis Cancer Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Robert T. O'Donnell, MD, PhD||University of California, Davis|