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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.
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.
Secondary ID [1] 0 0
A5961166
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioma 0 0
Medulloblastoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Children's - Brain

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Objective Response of Complete Response or Partial Response
Timepoint [1] 0 0
Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)
Secondary outcome [1] 0 0
Percentage of Participants With Objective Response of Complete Response or Partial Response, Investigator's Assessment
Timepoint [1] 0 0
Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)
Secondary outcome [2] 0 0
Duration of Response
Timepoint [2] 0 0
Baseline to Date of Tumor Response (Up to 1 Year)
Secondary outcome [3] 0 0
Time to Treatment Failure (TTF)
Timepoint [3] 0 0
Baseline to Date of Treatment Failure (Up to 1 Year)
Secondary outcome [4] 0 0
Time to Tumor Progression (TTP)
Timepoint [4] 0 0
Baseline to Date of Progression (Up to 1 Year)
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
Baseline to Date of Death (Up to 1 Year After Treatment)

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
Minimum age
6 Months
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diagnosis of brainstem glioma
* Concurrent administration of any other anti-tumor therapy
* Pre-existing uncontrolled diarrhea

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2011
Sample size
Target
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Westmead
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Herston
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Parkville
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Gent
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
Denmark
State/province [3] 0 0
Aarhus N
Country [4] 0 0
Denmark
State/province [4] 0 0
Koebenhavn OE
Country [5] 0 0
France
State/province [5] 0 0
Angers
Country [6] 0 0
France
State/province [6] 0 0
Bordeaux
Country [7] 0 0
France
State/province [7] 0 0
Lille
Country [8] 0 0
France
State/province [8] 0 0
Lyon Cedex 08
Country [9] 0 0
France
State/province [9] 0 0
Marseille
Country [10] 0 0
France
State/province [10] 0 0
Paris
Country [11] 0 0
France
State/province [11] 0 0
Villejuif
Country [12] 0 0
Italy
State/province [12] 0 0
Padova
Country [13] 0 0
Poland
State/province [13] 0 0
Warszawa
Country [14] 0 0
Spain
State/province [14] 0 0
Barcelona
Country [15] 0 0
Spain
State/province [15] 0 0
Murcia
Country [16] 0 0
Spain
State/province [16] 0 0
Madrid
Country [17] 0 0
Spain
State/province [17] 0 0
Sevilla
Country [18] 0 0
Spain
State/province [18] 0 0
Valencia
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Hampshire
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Birmingham
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Leeds
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Manchester
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Newcastle Upon Tyne
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Nottingham
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00404495
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00404495