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Sponsored by: |
AOI Pharma, Inc. |
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Information provided by: | AOI Pharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00389090 |
This is an open-label, multicenter, phase II trial, assessing the antitumor activity, and safety of temozolomide in combination with O6-BG in patients with temozolomide-resistant anaplastic glioma.
Condition | Intervention | Phase |
---|---|---|
Glioma Astrocytoma Oligodendroglioma Oligoastrocytoma |
Drug: Temozolomide and O6-Benzylguanine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Temozolomide and O6-Benzylguanine (O6-BG) in Patients With Temozolomide-Resistant Anaplastic Glioma |
Estimated Enrollment: | 116 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
This open-label, multicenter, phase II trial will assess the antitumor activity and safety of temozolomide in combination with O6-BG in patients with temozolomide-resistant anaplastic glioma.
Forty-one to 104 evaluable patients with temozolomide-resistant anaplastic glioma will be enrolled in this study. Total accrual on this study will not exceed 116 patients. The patients will receive daily temozolomide on 5 consecutive days (days 1-5) along with bolus infusions of O6-BG on days 1, 3, and 5 and a continuous infusion of O6-BG beginning immediately after the first bolus infusion and continuing until immediately prior to the last bolus injection. Patients will be evaluated for AEs during the course of therapy. Patients may receive treatment at the same dose level until appearance of significant treatment-related toxicities, disease progression or withdrawal of consent.
Tumor response will be evaluated at the end of cycle 1, cycle 2 and then every two cycles for the duration of therapy, using physical and neurological examinations and diagnostic imaging.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The following laboratory results:
Exclusion Criteria:
United States, California | |
AOI Pharmaceuticals Investigative Site | |
Los Angeles, California, United States, 90033 | |
United States, Florida | |
AOI Pharmaceuticals Investigative Site | |
Orlando, Florida, United States, 32804 | |
United States, Illinois | |
AOI Pharmaceuticals Investigative Site | |
Evanston, Illinois, United States, 60201 | |
AOI Pharmaceuticals Investigative Site | |
Chicago, Illinois, United States, 60611 | |
United States, Kentucky | |
AOI Pharmaceuticals Investigative Site | |
Lexington, Kentucky, United States, 40536 | |
AOI Pharmaceuticals Investigative Site | |
Louisville, Kentucky, United States, 40202 | |
United States, Minnesota | |
AOI Pharmaceuticals Investigative Site | |
Minneapolis, Minnesota, United States, 54407 | |
United States, North Carolina | |
AOI Pharmaceuticals Investigative Site | |
Durham, North Carolina, United States, 27710 | |
United States, South Carolina | |
AOI Pharmaceuticals Investigative Site | |
Greenville, South Carolina, United States, 29605 | |
United States, Texas | |
AOI Pharmaceuticals Investigative Site | |
Dallas, Texas, United States, 75246 | |
AOI Pharmaceuticals Investigative Site | |
Houston, Texas, United States, 77024 | |
United States, Utah | |
AOI Pharmaceuticals Investigative Site | |
Salt Lake City, Utah, United States, 84132 |
Study Chair: | Jennifer Quinn, MD | Preston Robert Tisch Brain Tumor Center at Duke |
Study ID Numbers: | O6BG 202 |
Study First Received: | October 16, 2006 |
Last Updated: | April 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00389090 |
Health Authority: | United States: Food and Drug Administration |
temozolomide resistant anaplastic glioma anaplastic astrocytoma anaplastic oligodendroglioma anaplastic oligoastrocytoma |
Neuroectodermal Tumors Astrocytoma Neoplasms, Germ Cell and Embryonal Neuroepithelioma O(6)-benzylguanine |
Oligodendroglioma Glioma Temozolomide Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Neoplasms, Nerve Tissue |
Enzyme Inhibitors Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents Pharmacologic Actions |