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Combination of Irinotecan and Temozolomide in Children With Brain Tumors.

NCT00404495 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2012-04-18

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2011-01-31
Completion
2011-12-31

Countries

  • Australia
  • Belgium
  • Denmark
  • France
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00404495 on ClinicalTrials.gov