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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00621686 |
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.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Biological: bevacizumab Drug: sorafenib tosylate Other: flow cytometry Other: immunoenzyme technique Other: laboratory biomarker analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Bevacizumab in Combination With Sorafenib in Recurrent Glioblastoma Multiforme |
Estimated Enrollment: | 53 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib twice daily on days 1-5 and 8-12 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 and stored for future pharmacogenetic research 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed glioblastoma multiforme as determined by pre-registration central pathology review
PATIENT CHARACTERISTICS:
No concurrent uncontrolled illness including, but not limited to, the following:
No inadequately controlled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 100 mm Hg while on antihypertensive medications)
No other active malignancy within the past 3 years, except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
More than 7 days since prior core biopsy or other minor surgical procedures
No concurrent therapeutic anticoagulation with warfarin
Study Chair: | Evanthia Galanis, MD | Mayo Clinic |
Responsible Party: | North Central Cancer Treatment Group ( Jan C. Buckner ) |
Study ID Numbers: | CDR0000587614, NCCTG-N0776 |
Study First Received: | February 21, 2008 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00621686 History of Changes |
Health Authority: | United States: Federal Government |
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma recurrent adult brain tumor |
Glioblastoma Astrocytoma Bevacizumab Central Nervous System Neoplasms Protein Kinase Inhibitors Angiogenesis Inhibitors Recurrence Brain Neoplasms Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Glioblastoma Multiforme Gliosarcoma Sorafenib Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Glioblastoma Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Central Nervous System Neoplasms Bevacizumab Protein Kinase Inhibitors Neoplasms by Site Neoplasms, Germ Cell and Embryonal Therapeutic Uses Glioma Angiogenesis Modulating Agents Growth Inhibitors |
Nervous System Neoplasms Neoplasms by Histologic Type Astrocytoma Growth Substances Nervous System Diseases Enzyme Inhibitors Angiogenesis Inhibitors Pharmacologic Actions Neuroectodermal Tumors Neoplasms Neoplasms, Neuroepithelial Sorafenib Neoplasms, Glandular and Epithelial |