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Sponsors and Collaborators: |
Duke University Eisai Inc. Genentech |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00735436 |
The primary objective of the study is to use 24 week survival to assess the efficacy of the combination of Gliadel followed by Avastin and irinotecan in the treatment of grade IV malignant glioma patients following surgical resection. The secondary objectives are to determine the progression-free survival following the combination of Gliadel followed by Avastin and irinotecan and to describe the toxicity of Gliadel followed by Avastin and irinotecan.
Condition | Intervention | Phase |
---|---|---|
Malignant Glioma Glioblastoma Multiforme Gliosarcoma |
Other: Taking EIAEDs (enzyme-inducing anticonvulsant medications) Other: NOT taking EIAEDs |
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 for Patients With Glioblastoma Multiforme (GBM) Treated With Gliadel Followed by Avastin Plus Irinotecan |
Estimated Enrollment: | 50 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1
Subjects taking enzyme-inducing anticonvulsant medications (EIAEDs) such as dilantin, tegretol, or phenobarbital.
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Other: Taking EIAEDs (enzyme-inducing anticonvulsant medications)
Those subjects who are taking EIAEDs (enzyme-inducing anticonvulsant medications) such as dilantin, tegretol, or phenobarbital.
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2
Subjects NOT taking enzyme-inducing anticonvulsant medications such as dilantin, tegretol, or phenobarbital.
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Other: NOT taking EIAEDs
Subjects NOT taking EIAEDs (enzyme-inducing anticonvulsant medications such as dilantin, tegretol, or phenobarbital.
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This is a phase II study of the combination of Gliadel followed by Avastin and irinotecan in grade IV malignant glioma patients. The study will have survival and toxicity endpoints. Subjects will be identified by the investigator as those patients who have histologically documented grade IV malignant glioma (glioblastoma multiforme or gliosarcoma) with recurrent or progressive disease who are able to undergo a GTR (gross total resection).
Gliadel wafer 1-8 wafers inserted at time of gross total resection (Phase I). Treatment cycle is 42 days in length. For patients with ≥ Grade 1 toxicity will allow 84 days prior to beginning therapy with Avastin and CPT-11.
Avastin Plus Irinotecan (Phase II, Cycles 1-12) consists of the following (cycle length is 6 weeks):
The primary objective of this phase II study is to determine whether the administration of Gliadel wafers followed by Avastin and irinotecan to patients with recurrent GBM is a treatment regimen worthy of further investigation in a randomized clinical trial. The basis for making this decision will be the proportion of patients who survive at least 24 weeks after initiation of protocol treatment.
In the initial Phase I and II clinical trials, four potential Avastin-associated safety signals were identified: hypertension, proteinuria, thromboembolic events, and hemorrhage. The two major toxicities associated with irinotecan are myelosuppression and diarrhea. Side effects associated with Gliadel are seizures, brain edema (swelling), healing abnormalities, wound infection and body pain.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: James J Vredenburgh, MD | 919-681-3824 | vrede001@mc.duke.edu |
Contact: Mary Lou Affronti, RN, MSN, ANP | 919-684-6239 | affro002@mc.duke.edu |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: James J Vredenburgh, MD 919-681-3824 vrede001@mc.duke.edu | |
Contact: Sarah Woodring, BS 919-684-2527 sarah.woodring@duke.edu | |
Principal Investigator: James J Vredenburgh, MD | |
Sub-Investigator: Mary Lou Affronti, RN, MSN, ANP |
Principal Investigator: | James J Vredenburgh, MD | Duke University |
Responsible Party: | Duke University Medical Center ( James Joseph Vredenburgh, MD ) |
Study ID Numbers: | 00006308 |
Study First Received: | August 13, 2008 |
Last Updated: | December 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00735436 |
Health Authority: | United States: Institutional Review Board |
Gliosarcoma Malignant glioma Glioblastoma multiforme GBM Gliadel Carmustine |
Irinotecan CPT-11 Camptosar Avastin Bevacizumab |
Excitatory Amino Acids Glioblastoma Phenobarbital Astrocytoma Carmustine Irinotecan Bevacizumab Phenytoin |
Neuroectodermal Tumors Glioblastoma multiforme Carbamazepine Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Gliosarcoma Neoplasms, Glandular and Epithelial |
Neurotransmitter Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances GABA Modulators Neoplasms, Nerve Tissue Physiological Effects of Drugs Central Nervous System Depressants Enzyme Inhibitors Excitatory Amino Acid Agents Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Therapeutic Uses Hypnotics and Sedatives GABA Agents Growth Inhibitors Angiogenesis Modulating Agents Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic Central Nervous System Agents Anticonvulsants Excitatory Amino Acid Antagonists |