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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00404495 |
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Date of registration:
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27/11/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Combination of Irinotecan and Temozolomide in Children With Brain Tumors.
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Scientific title:
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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. |
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Date of first enrolment:
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April 2007 |
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Target sample size:
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83 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00404495 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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Belgium
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Denmark
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France
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Italy
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Poland
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Spain
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United Kingdom
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Cohort 1: Recurrent or refractory medulloblastoma in which current standard treatment
approaches have failed; biopsy is not required for recurrent disease.
- Cohort 2: Newly-diagnosed high-grade glioma (World Health Organization [WHO] grade 3
or 4)
- Life expectancy = 3 months
Exclusion Criteria:
- Diagnosis of brainstem glioma
- Concurrent administration of any other anti-tumor therapy
- Pre-existing uncontrolled diarrhea
Age minimum:
6 Months
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Medulloblastoma
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Glioma
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Intervention(s)
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Drug: Irinotecan
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Drug: Temozolomide
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Primary Outcome(s)
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Percentage of Participants With Objective Response of Complete Response or Partial Response
[Time Frame: Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)]
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Secondary Outcome(s)
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Duration of Response
[Time Frame: Baseline to Date of Tumor Response (Up to 1 Year)]
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Overall Survival (OS)
[Time Frame: Baseline to Date of Death (Up to 1 Year After Treatment)]
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Time to Treatment Failure (TTF)
[Time Frame: Baseline to Date of Treatment Failure (Up to 1 Year)]
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Percentage of Participants With Objective Response of Complete Response or Partial Response, Investigator's Assessment
[Time Frame: Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)]
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Time to Tumor Progression (TTP)
[Time Frame: Baseline to Date of Progression (Up to 1 Year)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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