Combination of Irinotecan and Temozolomide in Children With Brain Tumors.

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NCT00404495

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Study Location
Pfizer Investigational Site
Westmead, New South Wales, 2145, Australia
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Glioma, Medulloblastoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-18 months
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Diagnosis of brainstem glioma


- Concurrent administration of any other anti-tumor therapy


- Pre-existing uncontrolled diarrhea

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Glioma, MedulloblastomaCombination of Irinotecan and Temozolomide in Children With Brain Tumors. NCT00404495
  1. Westmead, New South Wales
  2. Herston, Queensland
  3. Parkville, Victoria
  4. Gent,
  5. Leuven,
  6. Aarhus N,
  7. Koebenhavn OE,
  8. Angers,
  9. Bordeaux,
  10. Lille,
  11. Lyon Cedex 08,
  12. Marseille,
  13. Paris,
  14. Villejuif,
  15. Padova,
  16. Warszawa,
  17. Esplugues de Llobregat, Barcelona
  18. El Palmar, Murcia
  19. Barcelona,
  20. Madrid,
  21. Sevilla,
  22. Valencia,
  23. Soouthampton, Hampshire
  24. Birmingham,
  25. Leeds,
  26. Manchester,
  27. Newcastle Upon Tyne,
  28. Nottingham,
  29. Sutton,
ALL GENDERS
6 Months+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Combination of Irinotecan and Temozolomide in Children With Brain Tumors.
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Glioma
  • Medulloblastoma
Intervention  ICMJE
  • Drug: Irinotecan
    Irinotecan 10 mg/m^2 per day on days 1-5 and days 8-12 in repeated 3 week cycles
  • Drug: Temozolomide
    Temozolomide 100-125 mg/m^2 daily on days 1-5 in repeated 3 week cycles
Study Arms  ICMJE Experimental: Temozolomide + Irinotecan
Interventions:
  • Drug: Irinotecan
  • Drug: Temozolomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2011)		83
Original Enrollment  ICMJE
 (submitted: November 27, 2006)		75
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Months to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Denmark,   France,   Italy,   Poland,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00404495
Other Study ID Numbers  ICMJE A5961166
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP