Clinical trial NCT00404495: Combination of Irinotecan and Temozolomide in Children With Brain Tumors.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glioma
Medulloblastoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-11-28
Enrollment: 83
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Objective Response of Complete Response or Partial Response
timeFrame: Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)
Secondary outcomes:
measure: Percentage of Participants With Objective Response of Complete Response or Partial Response, Investigator's Assessment
timeFrame: Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)
measure: Duration of Response
timeFrame: Baseline to Date of Tumor Response (Up to 1 Year)
measure: Time to Treatment Failure (TTF)
timeFrame: Baseline to Date of Treatment Failure (Up to 1 Year)
measure: Time to Tumor Progression (TTP)
timeFrame: Baseline to Date of Progression (Up to 1 Year)
measure: Overall Survival (OS)
timeFrame: Baseline to Date of Death (Up to 1 Year After Treatment)
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Herston
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Parkville
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Aarhus N
country: Denmark
facility: Pfizer Investigational Site
city: Koebenhavn OE
country: Denmark
facility: Pfizer Investigational Site
city: Angers
country: France
facility: Pfizer Investigational Site
city: Bordeaux
country: France
facility: Pfizer Investigational Site
city: Lille
country: France
facility: Pfizer Investigational Site
city: Lyon Cedex 08
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Villejuif
country: France
facility: Pfizer Investigational Site
city: Padova
country: Italy
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Esplugues de Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: El Palmar
country: Spain
facility: Pfizer Investigational Site
state: Murcia
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Soouthampton
country: United Kingdom
facility: Pfizer Investigational Site
state: Hampshire
city: Birmingham
country: United Kingdom
facility: Pfizer Investigational Site
city: Leeds
country: United Kingdom
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Pfizer Investigational Site
city: Nottingham
country: United Kingdom
facility: Pfizer Investigational Site
city: Sutton
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: