Combination of Irinotecan and Temozolomide in Children With Brain Tumors.

Sponsor
Pfizer
Study ID
NCT00404495
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Months - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    Irinotecan 10 mg/m\^2 per day on days 1-5 and days 8-12 in repeated 3 week cycles
  • Temozolomide — DRUG
    Temozolomide 100-125 mg/m\^2 daily on days 1-5 in repeated 3 week cycles

Study Details

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.

Key Dates

Start date
Apr 30, 2007
Status verified
Apr 2012
Primary completion
Jan 31, 2011
Completion
Dec 31, 2011

Study Design

Enrollment
83 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Temozolomide + Irinotecan

Primary Outcome Measure

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) ]

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