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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00404495
Registration number
NCT00404495
Ethics application status
Date submitted
27/11/2006
Date registered
28/11/2006
Date last updated
18/04/2012
Titles & IDs
Public title
Combination of Irinotecan and Temozolomide in Children With Brain Tumors.
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Scientific 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.
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Secondary ID [1]
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A5961166
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Glioma
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Medulloblastoma
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Condition category
Condition code
Cancer
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Brain
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Cancer
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Children's - Brain
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Irinotecan
Treatment: Drugs - Temozolomide
Experimental: Temozolomide + Irinotecan -
Treatment: Drugs: Irinotecan
Irinotecan 10 mg/m\^2 per day on days 1-5 and days 8-12 in repeated 3 week cycles
Treatment: Drugs: Temozolomide
Temozolomide 100-125 mg/m\^2 daily on days 1-5 in repeated 3 week cycles
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Objective Response of Complete Response or Partial Response
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Assessment method [1]
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Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR persisted on repeat imaging study at least (=) 4 weeks after initial documentation of response. PR, for bidimensionally measurable disease, was a decrease by =50% of the sum of the products of the largest perpendicular diameters of all measurable lesions as determined by 2 observations not less than 4 weeks apart. Best overall response recorded any time while the participant was receiving treatment. External Response Review Committee (ERRC) assessment.
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Timepoint [1]
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Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)
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Secondary outcome [1]
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Percentage of Participants With Objective Response of Complete Response or Partial Response, Investigator's Assessment
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Assessment method [1]
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Percentage of participants with objective response based assessment of confirmed CR or confirmed PR. CR persisted on repeat imaging study =4 weeks after initial documentation of response. PR, in case of bidimensionally measurable disease, was a decrease by =50% of the sum of the products of the largest perpendicular diameters of all measurable lesions as determined by 2 observations not less than 4 weeks apart. Best overall response could be recorded any time while the participant was receiving treatment. Investigator's assessment.
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Timepoint [1]
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Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)
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Secondary outcome [2]
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Duration of Response
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Assessment method [2]
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Median duration (50%) of tumor response for participants with objective disease response: who have not progressed or died due to any cause; with a response and subsequent progression or death due to any cause for duration of response (DR). DR was defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurred first. DR (calculated in Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7. Investigator's assessment.
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Timepoint [2]
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Baseline to Date of Tumor Response (Up to 1 Year)
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Secondary outcome [3]
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Time to Treatment Failure (TTF)
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Assessment method [3]
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TTF was defined as the time from the date of first dose of study treatment to the date of the first documentation of progressive disease (PD), the date of treatment discontinuation except completion of treatment, or date of death due to cancer. Investigator's assessment.
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Timepoint [3]
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Baseline to Date of Treatment Failure (Up to 1 Year)
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Secondary outcome [4]
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Time to Tumor Progression (TTP)
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Assessment method [4]
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TTP was defined as the time in months from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever came first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7 multiplied by 4.33. Tumor progression was determined from oncologic assessment data (where data met the criteria for PD). Investigator's assessment.
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Timepoint [4]
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Baseline to Date of Progression (Up to 1 Year)
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Secondary outcome [5]
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Overall Survival (OS)
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Assessment method [5]
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Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7 multiplied by 4.33. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). Investigator's assessment.
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Timepoint [5]
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Baseline to Date of Death (Up to 1 Year After Treatment)
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Eligibility
Key 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
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Minimum age
6
Months
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Diagnosis of brainstem glioma
* Concurrent administration of any other anti-tumor therapy
* Pre-existing uncontrolled diarrhea
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2011
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Sample size
Target
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Accrual to date
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Final
83
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Pfizer Investigational Site - Westmead
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Recruitment hospital [2]
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Pfizer Investigational Site - Herston
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Recruitment hospital [3]
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Pfizer Investigational Site - Parkville
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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3052 - Parkville
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Gent
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Country [2]
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Belgium
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State/province [2]
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Leuven
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Country [3]
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Denmark
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State/province [3]
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Aarhus N
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Country [4]
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Denmark
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State/province [4]
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Koebenhavn OE
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Country [5]
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France
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State/province [5]
0
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Angers
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Country [6]
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France
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State/province [6]
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Bordeaux
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Country [7]
0
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France
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State/province [7]
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Lille
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Country [8]
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France
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State/province [8]
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Lyon Cedex 08
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Country [9]
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France
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State/province [9]
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Marseille
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Country [10]
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France
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State/province [10]
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Paris
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Country [11]
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France
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State/province [11]
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Villejuif
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Country [12]
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Italy
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State/province [12]
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Padova
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Country [13]
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Poland
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State/province [13]
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Warszawa
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Country [14]
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Spain
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State/province [14]
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Barcelona
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Country [15]
0
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Spain
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State/province [15]
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Murcia
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Country [16]
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Spain
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State/province [16]
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Madrid
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Country [17]
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Spain
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State/province [17]
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Sevilla
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Country [18]
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Spain
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State/province [18]
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Valencia
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Country [19]
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United Kingdom
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State/province [19]
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Hampshire
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Country [20]
0
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United Kingdom
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State/province [20]
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Birmingham
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Country [21]
0
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United Kingdom
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State/province [21]
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Leeds
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Country [22]
0
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United Kingdom
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State/province [22]
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Manchester
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Country [23]
0
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United Kingdom
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State/province [23]
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Newcastle Upon Tyne
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Country [24]
0
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United Kingdom
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State/province [24]
0
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Nottingham
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Country [25]
0
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United Kingdom
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State/province [25]
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00404495
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00404495
Download to PDF