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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00404495 |
This study will assess the rate of objective confirmed tumor response of irinotecan in combination with temozolomide in children with recurrent or refractory medulloblastoma and in children with newly diagnosed high-grade glioma.
Condition | Intervention | Phase |
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Glioma Medulloblastoma |
Drug: Irinotecan Drug: Temozolomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase 2 Single-Arm, Open Label Study Of Irinotecan In Combination With Temozolomide In Children With Recurrent Or Refractory Medulloblastoma And In Children With Newly Diagnosed High-Grade Glioma. |
Estimated Enrollment: | 75 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Irinotecan
Irinotecan 10 mg/m2 per day on days 1-5 and days 8-12 in repeated 3 week cycles
Drug: Temozolomide
Temozolomide 100-125 mg/m2 daily on days 1-5 in repeated 3 week cycles
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Ages Eligible for Study: | 6 Months to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer Oncology Clinical Trial Information Service | 1-877-369-9753 | PfizerCancerTrials@emergingmed.com |
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A5961166 |
Study First Received: | November 27, 2006 |
Last Updated: | December 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00404495 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Neuroectodermal Tumors Brain Neoplasms Neuroectodermal Tumors, Primitive Neoplasms, Germ Cell and Embryonal Irinotecan Medulloblastoma |
Neuroepithelioma Glioma Temozolomide Recurrence 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 Antineoplastic Agents, Phytogenic Alkylating Agents Pharmacologic Actions |