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Sponsored by: |
University of California, San Francisco |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00525525 |
This is a phase II study of Bevacizumab plus Temodar and Tarceva in patients with non-progressive glioblastoma or gliosarcoma. Patients must have stable disease immediately following a standard course of up-front radiotherapy and Temodar. All patients will receive Bevacizumab, Temodar and Tarceva. A total of 60 patients will be enrolled. Our hypothesis is that the combination of Bevacizumab plus Temodar and Tarceva will increase survival over that seen in historical controls who have newly diagnosed, non-progressive glioblastoma or gliosarcoma following radiotherapy plus Temodar and use Temodar alone.
Condition | Intervention | Phase |
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Glioblastoma Gliosarcoma |
Drug: Avastin Drug: Tarceva Drug: Temodar |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | A Phase II Study of Bevacizumab Plus Temodar and Tarceva After Radiation Therapy and Temodar in Patients With Newly Diagnosed Glioblastoma or Gliosarcoma Who Are Stable Following Radiation |
Estimated Enrollment: | 60 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients must not have proteinuria at screening as demonstrated by either
Contact: Teresa Urquhart, BA | 415-353-2653 | urquhartt@neurosurg.ucsf.edu |
United States, California | |
University of California San Francisco | Recruiting |
San Francisco, California, United States, 94143 |
Principal Investigator: | Michael D. Prados, MD | University of California, San Francisco |
Responsible Party: | UCSF ( Michael Prados, MD ) |
Study ID Numbers: | 07105, unknown |
Study First Received: | September 4, 2007 |
Last Updated: | May 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00525525 |
Health Authority: | United States: Food and Drug Administration |
Glioblastoma Gliosarcoma Bevacizumab Avastin |
Erlotinib Tarceva Temozolomide Temodar |
Erlotinib Neuroectodermal Tumors Glioblastoma Astrocytoma Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Bevacizumab Glioma Gliosarcoma Temozolomide Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Neoplasms, Nerve Tissue Enzyme Inhibitors Protein Kinase Inhibitors Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Therapeutic Uses Growth Inhibitors Antineoplastic Agents, Alkylating Angiogenesis Modulating Agents Neoplasms, Neuroepithelial Alkylating Agents |