Combination of Irinotecan and Temozolomide in Children With Brain Tumors.
NCT ID: NCT00404495
Last Updated: 2012-04-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
83 participants
INTERVENTIONAL
2007-04-30
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Temozolomide + Irinotecan
Irinotecan
Irinotecan 10 mg/m\^2 per day on days 1-5 and days 8-12 in repeated 3 week cycles
Temozolomide
Temozolomide 100-125 mg/m\^2 daily on days 1-5 in repeated 3 week cycles
Interventions
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Irinotecan
Irinotecan 10 mg/m\^2 per day on days 1-5 and days 8-12 in repeated 3 week cycles
Temozolomide
Temozolomide 100-125 mg/m\^2 daily on days 1-5 in repeated 3 week cycles
Eligibility Criteria
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Inclusion Criteria
* Cohort 2: Newly-diagnosed high-grade glioma (World Health Organization \[WHO\] grade 3 or 4)
* Life expectancy ≥ 3 months
Exclusion Criteria
* Concurrent administration of any other anti-tumor therapy
* Pre-existing uncontrolled diarrhea
6 Months
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Westmead, New South Wales, Australia
Pfizer Investigational Site
Herston, Queensland, Australia
Pfizer Investigational Site
Parkville, Victoria, Australia
Pfizer Investigational Site
Ghent, , Belgium
Pfizer Investigational Site
Leuven, , Belgium
Pfizer Investigational Site
Aarhus N, , Denmark
Pfizer Investigational Site
Koebenhavn OE, , Denmark
Pfizer Investigational Site
Angers, , France
Pfizer Investigational Site
Bordeaux, , France
Pfizer Investigational Site
Lille, , France
Pfizer Investigational Site
Lyon, , France
Pfizer Investigational Site
Marseille, , France
Pfizer Investigational Site
Paris, , France
Pfizer Investigational Site
Villejuif, , France
Pfizer Investigational Site
Padua, , Italy
Pfizer Investigational Site
Warsaw, , Poland
Pfizer Investigational Site
Barcelona, Barcelona, Spain
Pfizer Investigational Site
Esplugues de Llobregat, Barcelona, Spain
Pfizer Investigational Site
Madrid, Madrid, Spain
Pfizer Investigational Site
El Palmar, Murcia, Spain
Pfizer Investigational Site
Seville, Sevilla, Spain
Pfizer Investigational Site
Valencia, Valencia, Spain
Pfizer Investigational Site
Soouthampton, Hampshire, United Kingdom
Pfizer Investigational Site
Birmingham, , United Kingdom
Pfizer Investigational Site
Leeds, , United Kingdom
Pfizer Investigational Site
Manchester, , United Kingdom
Pfizer Investigational Site
Newcastle upon Tyne, , United Kingdom
Pfizer Investigational Site
Nottingham, , United Kingdom
Pfizer Investigational Site
Sutton, , United Kingdom
Countries
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Related Links
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Other Identifiers
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A5961166
Identifier Type: -
Identifier Source: org_study_id
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