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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center Genentech |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00782756 |
The purpose of this study is to test the safety of a new plan for treating glioblastoma. The usual first treatment for glioblastoma is to give focused radiation over 6 weeks in combination with a chemotherapy called temozolomide. In this study the radiation will be given over 2 weeks in combination with temozolomide and another drug, bevacizumab, will also be given. Our idea is that this treatment plan may attack both the tumor and the blood vessels feeding the tumor more effectively. This study will look at what effects, good or bad, this approach has on the patient and the tumor.
Condition | Intervention | Phase |
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Brain Cancer Malignant Glioma |
Other: radiotherapy (RT) in combination with temozolomide and bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma |
Estimated Enrollment: | 25 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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RT, with temozolomide and bevacizumab: Experimental
This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.
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Other: radiotherapy (RT) in combination with temozolomide and bevacizumab
Bevacizumab10 mg/kg IV once every two weeks on days 1 and 14 of every cycle (Cycle defined as 28 days). Temozolomide 75mg/m2 daily beginning on day 1 through completion of radiotherapy. Hypofractionated dose painting IMRT will start on day 1 and will be delivered on a Monday, Wednesday, Friday schedule for a total of 6 fractions. Post RT therapy: Bevacizumab 10mg/kg IV every two weeks. Temozolomide 150-200mg/m2 daily for 5 consecutive days will be given on 28 day cycles. Follow up: CBC weekly, comprehensive metabolic panel, urinalysis and blood pressure every other week. Neurological/physical examination monthly. Gd-enhanced MRI with perfusion every 2 cycles. Neurocognitive assessment at approximately 4-5 months post-surgery and then every 6 months. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lauren Abrey, MD | abreyl@mskcc.org | |
Contact: Kathryn Beal, MD | bealk@mskcc.org |
United States, New Jersey | |
Memoral Sloan Kettering Cancer Center | Recruiting |
Basking Ridge, New Jersey, United States | |
Contact: Lauren Abrey, MD abreyl@mskcc.org | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Lauren Abrey, MD abreyl@mskcc.org | |
Contact: Kathryn Beal, MD bealk@mskcc.org | |
Principal Investigator: Lauren Abrey, MD | |
Memorial Sloan-Kettering Cancer Center at Commack | Recruiting |
Commack, New York, United States, 11725 | |
Contact: Lauren Abrey, MD abreyl@mskcc.org |
Principal Investigator: | Lauren Abrey, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Lauren Abrey, MD ) |
Study ID Numbers: | 08-126 |
Study First Received: | October 29, 2008 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00782756 History of Changes |
Health Authority: | United States: Institutional Review Board |
Radiation BEVACIZUMAB (AVASTIN) TEMOZOLOMIDE |
Central Nervous System Diseases Central Nervous System Neoplasms Bevacizumab Brain Diseases Angiogenesis Inhibitors Temozolomide Brain Neoplasms Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Antineoplastic Agents, Alkylating Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Central Nervous System Neoplasms Bevacizumab Brain Diseases Neoplasms by Site Neoplasms, Germ Cell and Embryonal Therapeutic Uses Growth Inhibitors Glioma Angiogenesis Modulating Agents Alkylating Agents |
Nervous System Neoplasms Neoplasms by Histologic Type Growth Substances Nervous System Diseases Central Nervous System Diseases Temozolomide Angiogenesis Inhibitors Pharmacologic Actions Neuroectodermal Tumors Brain Neoplasms Neoplasms Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial |