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Sponsors and Collaborators: |
Duke University AOI Pharma, Inc. National Institutes of Health (NIH) |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00613093 |
Objectives:
To define role of O6-Benzylguanine (BG) in restoring Temodar sensitivity in pts w Temodar-resistant malignant glioma.
To further define toxicity of combo therapy using Temodar + BG.
Condition | Intervention | Phase |
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Glioblastoma Gliosarcoma |
Drug: Temodar and O6-Benzylguanine |
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 Temodar Plus O6-Benzylguanine (O6-BG) (NSC 637037) in the Treatment of Patients With Temodar-Resistant Malignant Glioma |
Enrollment: | 64 |
Study Start Date: | October 2002 |
Estimated Study Completion Date: | December 2008 |
Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Pts w GBM
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Drug: Temodar and O6-Benzylguanine
Objectives of study are to define role of O6-BG in restoring Temo sensitivity in pts w Temo -resistant MG & to further define toxicity of comb0 therapy using Temo + BG. 2 separate strata accrued independently of each other: Stratum 1-pts w GBM. Stratum 2-pts w anaplastic astrocytoma. O6-BG at 120mg/m2 administered intravenously over 1hr followed immediately by 48hr infusion at 30mg/m2/24 hrs. Temo 472mg/m2 administered orally, in fasting state, within 60mins of end of 1hr administration of O6-BG infusion. Treatment cycles may be repeated every 28 days following dose of Temo from previous cycle. |
2: Experimental
Pts w AA
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Drug: Temodar and O6-Benzylguanine
Objectives of study are to define role of O6-BG in restoring Temo sensitivity in pts w Temo -resistant MG & to further define toxicity of comb0 therapy using Temo + BG. 2 separate strata accrued independently of each other: Stratum 1-pts w GBM. Stratum 2-pts w anaplastic astrocytoma. O6-BG at 120mg/m2 administered intravenously over 1hr followed immediately by 48hr infusion at 30mg/m2/24 hrs. Temo 472mg/m2 administered orally, in fasting state, within 60mins of end of 1hr administration of O6-BG infusion. Treatment cycles may be repeated every 28 days following dose of Temo from previous cycle. |
2 separate strata accrued independently of each other: Stratum 1-pts w GM. Stratum 2-pts w AA.
O6-BG at 120mg/m2 administered intravenously over 1hr followed immediately by 48hr infusion at 30mg/m2/ 24hrs. Temo 472mg/m2 administered orally, in fasting state, within 60mins of end of 1hr administration of O6-BG infusion. Treatment cycles may be repeated every 28 days following dose of Temo from previous cycle.
Temo has been well tolerated by both adults & children w most common toxicity being mild myelosuppression. Other, less likely, potential toxicities include nausea & vomiting, constipation, headache, alopecia, rash, burning sensation of skin, esophagitis, pain, diarrhea, lethargy, hepatotoxicity, anorexia, fatigue and hyperglycemia. Hypersensitivity reactions have not yet been noted with Temo. As in the case w many anti-cancer drugs, Temo may be carcinogenic. O6-BG toxicities include agitation, lethargy, nausea, vomiting, rapid heart rate, elevated liver functions, & leukemia; but, not with O6-BG as single agent. Transient lymphopenia has been seen w O6-BG as single agent.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
United States, North Carolina | |
Duke University Health System | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Jennifer Quinn, MD | Duke University Health System |
Responsible Party: | Duke University Health System ( Jennifer A. Quinn, MD ) |
Study ID Numbers: | 4260 |
Study First Received: | January 29, 2008 |
Last Updated: | May 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00613093 |
Health Authority: | United States: Food and Drug Administration |
Temodar Temozolomide O6-BG O6-Benzylguanine NSC 637037 Temodar-Resistant Malignant Glioma |
Brain tumor CNS tumor Cerebral glioblastoma Anaplastic astrocytomas Glioma |
Neuroectodermal Tumors Brain Neoplasms Glioblastoma Astrocytoma Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
O(6)-benzylguanine Glioma Central Nervous System Neoplasms Gliosarcoma 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 |