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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 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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: | May 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00404495 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Neuroectodermal Tumors, Primitive Irinotecan Temozolomide Recurrence Brain Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Medulloblastoma Neuroepithelioma Glioma Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Alkylating Agents Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neuroectodermal Tumors, Primitive Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Irinotecan Enzyme Inhibitors Temozolomide Pharmacologic Actions Neuroectodermal Tumors |
Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Medulloblastoma Glioma Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic Alkylating Agents Neoplasms, Glandular and Epithelial |