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Trial record 1 of 1 for:    NCT00404495
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Combination of Irinotecan and Temozolomide in Children With Brain Tumors.

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ClinicalTrials.gov Identifier: NCT00404495
Recruitment Status : Completed
First Posted : November 28, 2006
Results First Posted : February 17, 2012
Last Update Posted : April 18, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 27, 2006
First Posted Date  ICMJE November 28, 2006
Results First Submitted Date  ICMJE January 13, 2012
Results First Posted Date  ICMJE February 17, 2012
Last Update Posted Date April 18, 2012
Study Start Date  ICMJE April 2007
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2012)
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) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 27, 2006)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2012)
  • 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) ]
    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.
  • Duration of Response [ Time Frame: Baseline to Date of Tumor Response (Up to 1 Year) ]
    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.
  • Time to Treatment Failure (TTF) [ Time Frame: Baseline to Date of Treatment Failure (Up to 1 Year) ]
    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.
  • Time to Tumor Progression (TTP) [ Time Frame: Baseline to Date of Progression (Up to 1 Year) ]
    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.
  • Overall Survival (OS) [ Time Frame: Baseline to Date of Death (Up to 1 Year After Treatment) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2006)
The duration of tumor response Time to tumor progression (TTP) Time to treatment failure (TTF) Overall survival (OS) The safety and tolerability of the combination of irinotecan and temozolomide
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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