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Bevacizumab and Sorafenib in Treating Patients With Recurrent Glioblastoma Multiforme

Phase 2
Completed
Conditions
Brain and Central Nervous System Tumors
Interventions
Biological: bevacizumab
Registration Number
NCT00621686
Lead Sponsor
Alliance for Clinical Trials in Oncology
Brief Summary

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. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving bevacizumab together with sorafenib may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving bevacizumab together with sorafenib works in treating patients with recurrent glioblastoma multiforme.

Detailed Description

OBJECTIVES:

Primary

* Identify the clinical efficacy of bevacizumab and sorafenib, as measured by 6-month progression-free survival, in patients with recurrent glioblastoma multiforme.

Secondary

* Assess time to progression of this patient population.

* Assess overall survival of this patient population.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib once daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood and plasma sample collection at baseline and then periodically during study treatment for translational research studies. Translational research studies include analysis of circulating endothelial cells and circulating endothelial progenitor cells by flow cytometry and measurement of angiogenic proteins in plasma by ELISA. DNA and buffy coat are extracted and collected from the blood samples for pharmacogenetic studies.

Quality of life is assessed at baseline, prior to every other treatment course, and at the end of treatment.

After completion of study treatment, patients are followed at 28-42 days, every 3 months for 5 years, and then annually for 10 years.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
54
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Sorafenib + Bevacizumab/Group Asorafenib tosylatePatients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days. Patients undergo blood and plasma sample collection at baseline and then periodically during study treatment for translational research studies. Translational research studies include analysis of circulating endothelial cells and circulating endothelial progenitor cells by flow cytometry and measurement of angiogenic proteins in plasma by ELISA. DNA and buffy coat are extracted and collected from the blood samples for pharmacogenetic studies. Quality of life is assessed at baseline, prior to every other treatment course, and at the end of treatment. After completion of study treatment, patients are followed at 28-42 days, every 3 months for 5 years, and then annually for 10 years.
Sorafenib + Bevacizumab /Group Bsorafenib tosylatePatients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days. Patients undergo blood and plasma sample collection at baseline and then periodically during study treatment for translational research studies. Translational research studies include analysis of circulating endothelial cells and circulating endothelial progenitor cells by flow cytometry and measurement of angiogenic proteins in plasma by ELISA. DNA and buffy coat are extracted and collected from the blood samples for pharmacogenetic studies. Quality of life is assessed at baseline, prior to every other treatment course, and at the end of treatment. After completion of study treatment, patients are followed at 28-42 days, every 3 months for 5 years, and then annually for 10 years.
Sorafenib + Bevacizumab/Group AbevacizumabPatients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days. Patients undergo blood and plasma sample collection at baseline and then periodically during study treatment for translational research studies. Translational research studies include analysis of circulating endothelial cells and circulating endothelial progenitor cells by flow cytometry and measurement of angiogenic proteins in plasma by ELISA. DNA and buffy coat are extracted and collected from the blood samples for pharmacogenetic studies. Quality of life is assessed at baseline, prior to every other treatment course, and at the end of treatment. After completion of study treatment, patients are followed at 28-42 days, every 3 months for 5 years, and then annually for 10 years.
Sorafenib + Bevacizumab /Group BbevacizumabPatients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days. Patients undergo blood and plasma sample collection at baseline and then periodically during study treatment for translational research studies. Translational research studies include analysis of circulating endothelial cells and circulating endothelial progenitor cells by flow cytometry and measurement of angiogenic proteins in plasma by ELISA. DNA and buffy coat are extracted and collected from the blood samples for pharmacogenetic studies. Quality of life is assessed at baseline, prior to every other treatment course, and at the end of treatment. After completion of study treatment, patients are followed at 28-42 days, every 3 months for 5 years, and then annually for 10 years.
Primary Outcome Measures
NameTimeMethod
6-month Progression-free Survivalat 6 months

Primary Endpoint: 6-month progression free survival (PFS6): The proportion of successes will be estimated using the binomial point estimator (number of successes divided by the total number of evaluable patients) and the binomial 95% confidence interval estimated. To be classified as a success, an evaluable patient must be alive and progression-free 6 months after registration to the study. Patients who die prior to 6 months after study registration will be considered to have failed. Progression is defined as a \>25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions compared to pretreatment MRI and/or CT scan.

Secondary Outcome Measures
NameTimeMethod
Overall SurvivalTime from date of registration to a) date of death due to any cause or b) last follow-up; Up to 15 years

Overall survival (OS) is defined as the length of time from date of registration to a) date of death due to any cause or b) last follow-up.

Time to ProgressionTime from study registration to a) date of disease progression, or b) last follow-up; Up to 15 years

Time to progression (TTP) is defined to be the length of time from study registration to a) date of disease progression as defined by section 11.0 of the protocol, or b) last follow-up. If a patient dies without documentation of disease progression, the patient will be considered to have had a tumor progression at the time of death unless there is sufficient documented evidence to conclude no progression occurred prior to death. Time to progression curves were compared via the log-rank test. Progression is defined as a \>25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions compared to pretreatment MRI and/or CT scan.

Trial Locations

Locations (202)

Mayo Clinic Scottsdale

🇺🇸

Scottsdale, Arizona, United States

Cancer Care Associates

🇺🇸

Fresno, California, United States

Front Range Cancer Specialists

🇺🇸

Fort Collins, Colorado, United States

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

🇺🇸

Hartford, Connecticut, United States

Baptist Cancer Institute - Jacksonville

🇺🇸

Jacksonville, Florida, United States

Mayo Clinic - Jacksonville

🇺🇸

Jacksonville, Florida, United States

Rush-Copley Cancer Care Center

🇺🇸

Aurora, Illinois, United States

Carle Cancer Center at Carle Foundation Hospital

🇺🇸

Urbana, Illinois, United States

CCOP - Carle Cancer Center

🇺🇸

Urbana, Illinois, United States

St. Francis Hospital and Health Centers - Beech Grove Campus

🇺🇸

Beech Grove, Indiana, United States

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Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States

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