Combination of Irinotecan and Temozolomide in Children With Brain Tumors.

Phase 2

Completed

• Conditions: Medulloblastoma; Glioma
• Interventions: Drug: Irinotecan; Drug: Temozolomide

• Registration Number: NCT00404495
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2006-11-27
• Study First Submitted QC: 2006-11-27
• Study First Posted: 2006-11-28
• Study Start: 2007-04
• Primary Completion: 2011-01
• Study Completion: 2011-12
• Results First Submitted: 2012-01-13
• Results First Submitted QC: 2012-01-13
• Results First Posted: 2012-02-17
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-16
• Last Update Posted: 2012-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Temozolomide + Irinotecan	Irinotecan	-
Temozolomide + Irinotecan	Temozolomide	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Objective Response of Complete Response or Partial Response	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.

Secondary Outcome Measures

Name	Time	Method
Time to Treatment Failure (TTF)	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)	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.
Percentage of Participants With Objective Response of Complete Response or Partial Response, Investigator's Assessment	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	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.
Overall Survival (OS)	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Sutton, United Kingdom