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Sponsors and Collaborators: |
Schering-Plough Schering Canada, Inc. |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00392171 |
The purpose of this non-randomized, open-label, multicenter, Phase II, 2-stage design, RESCUE study is to test the hypothesis that continuous 28-day oral dosing (28/28) with dose-intense temozolomide (50 mg/m2) for up to 12 months may overcome resistance and be effective in the management of adult patients with malignant glioma who have failed following at least 2 cycles (2 months) of conventional 5-day (5/28) cycles of high-dose temozolomide (150-200 mg/m2).
Condition | Intervention | Phase |
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Glioma Astrocytoma Oligodendroglioma Glioblastoma |
Drug: Temozolomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | The Temozolomide RESCUE Study: A Phase II Trial of Continuous (28/28) Dose-Intense Temozolomide (CDIT) Chemotherapy After Progression on Conventional 5/28 Day Temozolomide in Patients With Recurrent Malignant Glioma |
Estimated Enrollment: | 90 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Temozolomide: Experimental
Temozolomide will be administered at a dose of 50mg/m2 for cycles of 28 days for 12 months or until progression.
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Drug: Temozolomide
Subjects will receive temozolomide 50 mg/m2 for cycles of 28 days for 12 months or until progression
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Ages Eligible for Study: | 19 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Nabil Abadir, MD - Medical Director, Canada Country Operations ) |
Study ID Numbers: | P04601 |
Study First Received: | October 24, 2006 |
Last Updated: | March 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00392171 History of Changes |
Health Authority: | Canada: Health Canada |
Glioblastoma Astrocytoma Disease Progression Temozolomide Recurrence Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Oligodendroglioma Glioma Antineoplastic Agents, Alkylating Alkylating Agents Neoplasms, Glandular and Epithelial |
Glioblastoma Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Astrocytoma Antineoplastic Agents Neoplasms, Nerve Tissue Temozolomide Pharmacologic Actions Neuroectodermal Tumors |
Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Oligodendroglioma Glioma Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents Neoplasms, Glandular and Epithelial |