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Sponsors and Collaborators: |
Duke University Genentech |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00612430 |
Primary Objective to estimate 6-month progression free survival probability of pts w recurrent malignant glioma treated w Etoposide + bevacizumab.
Secondary Objectives To evaluate safety & tolerability of Etoposide + bevacizumab among pts w recurrent malignant glioma.
To evaluate radiographic response, progression free survival & overall survival of pts w recurrent malignant glioma treated w Etoposide + bevacizumab.
Condition | Intervention | Phase |
---|---|---|
Glioblastoma Gliosarcoma |
Drug: Bevacizumab and Etoposide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Trial of Bevacizumab Plus Etoposide for Patients With Recurrent Malignant Glioma |
Estimated Enrollment: | 59 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Exploratory, single-arm, ph II study designed to assess anti-tumor activity of combinatorial regimen consisting of Etoposide + bevacizumab among pts w RMG. Primary endpoint of study is probability of progression-free survival at 6 mths. Important secondary objective is to further assess safety of Etoposide & bevacizumab for pts w RMG.
If study demonstrates that combinatorial regimen of Etoposide + bevacizumab is associated w encouraging anti-tumor activity among pts w RMG, further assessment of regimen in additional ph II & possibly ph III studies, will be considered.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David A. Reardon, MD | (919) 668-1409 | david.reardon@duke.edu |
Contact: Julie Norfleet | (919) 684-8491 | julie.norfleet@duke.edu |
United States, North Carolina | |
Duke University Health System | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: David A. Reardon, MD 919-668-1409 david.reardon@duke.edu | |
Contact: Julie Norfleet (919) 684-8491 julie.norfleet@duke.edu |
Principal Investigator: | David A. Reardon, MD | Duke University Health System |
Responsible Party: | Duke University Health System ( David A. Reardon, MD ) |
Study ID Numbers: | 00000379 |
Study First Received: | January 29, 2008 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00612430 |
Health Authority: | United States: Institutional Review Board |
Gliosarcoma Glioblastoma GBM MG Brain tumor Bevacizumab Avastin Etoposide |
VP-16 Etopophos Toposar VePesid Glioblastoma multiforme Recurrent GBM Anaplastic astrocytoma Malignant glioma |
Glioblastoma Astrocytoma Bevacizumab Etoposide phosphate Recurrence Brain Neoplasms Neuroectodermal Tumors |
Glioblastoma multiforme Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Gliosarcoma Etoposide Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Physiological Effects of Drugs Angiogenesis Inhibitors Pharmacologic Actions |
Neoplasms Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic |