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Combination of Irinotecan and Temozolomide in Children With Brain Tumors.

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NCT00404495

Last updated on May 11, 2018
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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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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

NCT00404495
Pfizer
Completed
Combination of Irinotecan and Temozolomide in Children With Brain Tumors.

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Combination of Irinotecan and Temozolomide in Children With Brain Tumors.
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.
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Glioma
  • Medulloblastoma
  • 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
Experimental: Temozolomide + Irinotecan
Interventions:
  • Drug: Irinotecan
  • Drug: Temozolomide
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
December 2011
January 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Months to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Denmark,   France,   Italy,   Poland,   Spain,   United Kingdom
 
 
NCT00404495
A5961166
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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