Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Duke University Millennium Pharmaceuticals, Inc. Genentech |
---|---|
Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00611325 |
Primary Objective To estimate 6-month progression free survival probability of pts w recurrent glioblastoma multiforme treated w bortezomib + Avastin. This efficacy assessment will be made separately among pts on enzyme-inducing anti-epileptic drugs and non enzyme-inducing anti-epileptic drugs.
Secondary Objectives To evaluate safety & tolerability of bortezomib + Avastin among pts w RMG. To evaluate radiographic response, progression free survival & overall survival of pts w RMG treated w bortezomib + Avastin
Condition | Intervention | Phase |
---|---|---|
Glioblastoma Gliosarcoma |
Drug: Avastin and Bortezomib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Trial of Avastin Plus Bortezomib for Patients With Recurrent Malignant Glioma |
Estimated Enrollment: | 64 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1
Pts taking EIAEDs
|
Drug: Avastin and Bortezomib
Avastin will be administered intravenously at the dose 15 mg/kg every 3 weeks. Bortezomib will be administered on day 1, 4, 8, 11, 22, 25, 29, & 32 of a 42 day cycle. Bortezomib will be 1.7 mg/m2 for pts on non-EIAED & 2.5 mg/m2 for pts on EIAED. If pt tolerates 1st Avastin & bortezomib doses, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Duke investigators will review all lab data & order treatment. Treatment will continue until either evidence of progressive disease, unacceptable toxicity (if bortezomib has to be discontinued due to severe, persistent toxicity, pts will continue on Avastin as single agent), non-compliance with study follow-up, or withdrawal of consent.
|
2
Pts not taking EIAEDs
|
Drug: Avastin and Bortezomib
Avastin will be administered intravenously at the dose 15 mg/kg every 3 weeks. Bortezomib will be administered on day 1, 4, 8, 11, 22, 25, 29, & 32 of a 42 day cycle. Bortezomib will be 1.7 mg/m2 for pts on non-EIAED & 2.5 mg/m2 for pts on EIAED. If pt tolerates 1st Avastin & bortezomib doses, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Duke investigators will review all lab data & order treatment. Treatment will continue until either evidence of progressive disease, unacceptable toxicity (if bortezomib has to be discontinued due to severe, persistent toxicity, pts will continue on Avastin as single agent), non-compliance with study follow-up, or withdrawal of consent.
|
This is dual-center, open-label, 2-arm ph II study assessing safety & efficacy of bortezomib in combo w Avastin for pts w recurrent glioblastoma multiforme (gbm). 64 total pts at both sites w recurrent WHO gr IV malignant gliomas will be enrolled in study. Avastin administered intravenously at dose 15 mg/kg every 3wks. Bortezomib administered on day 1,4, 8, 11, 22, 25, 29, & 32 of 42-day cycle. Dose of bortezomib will be 1.7 mg/m2 for non-EIAED pts & 2.5 mg/m2 for EIAED pts. Treatment will continue until either evidence of progressive disease, unacceptable toxicity, non-compliance w study follow-up / withdrawal of consent. Brain MRIs will be obtained after every cycle.
Bortezomib administration is associated w mild toxicity in most pts, such as fatigue, diarrhea & nausea, constipation & peripheral neuropathy. Less common, bortezomib administration leads to more significant hematologic toxicities & peripheral neuropathies. Most significant toxicities associated w Avastin in recently completed ph II clinical trial at Duke were thrombotic complications & gr2 proteinuria. "Unacceptable" toxicities rates of 15 percent/< are considered desirable, while rates of 40 percent/>are considered as undesirable. Statistical hypothesis that needs testing differentiates between 15 percent & 40 percent rate of unacceptable toxicity.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Pts have histologically confirmed diagnosis of recurrent/progressive WHO grade IV MG
Exclusion Criteria:
Co-medication that may interfere w study result
•>3 prior recurrences
Requires therapeutic anti-coagulation
•>4 wks from Day 0 of prior monthly chemo. >1 wk from last dose of daily chemo / targeted therapies administered daily
Contact: James J Vredenburgh, MD | (919) 681-3824 | james.vredenburgh@duke.edu |
Contact: Julie Norfleet | (919) 668-0673 | julie.norfleet@duke.edu |
United States, North Carolina | |
Duke University Health System | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: James J Vredenburgh, MD 919-681-3824 james.vredenburgh@duke.edu | |
Contact: Julie Norfleet (919) 668-0673 julie.norfleet@duke.edu | |
Principal Investigator: James J Vredenburgh, MD |
Principal Investigator: | James J Vredenburgh, MD | Duke University Health System |
Responsible Party: | Duke University Health System ( James J Vredenburgh ) |
Study ID Numbers: | 00003596 |
Study First Received: | January 28, 2008 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00611325 |
Health Authority: | United States: Institutional Review Board |
Gliosarcoma Glioblastoma Glioblastoma multiforme Recurrent malignant glioma GBM Recurrent GBM |
Malignant glioma Brain tumor Avastin Bevacizumab Bortezomib Velcade |
Glioblastoma Astrocytoma Bortezomib Bevacizumab Recurrence Brain Neoplasms Neuroectodermal Tumors |
Glioblastoma multiforme Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Gliosarcoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Physiological Effects of Drugs Enzyme Inhibitors Angiogenesis Inhibitors |
Pharmacologic Actions Protease Inhibitors Neoplasms Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Neoplasms, Neuroepithelial |