Combination of Irinotecan and Temozolomide in Children With Brain Tumors.

Glioma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00404495
• Other study ID #: A5961166
• Status: Completed
• Phase: Phase 2
• First received: November 27, 2006
• Last updated: April 16, 2012
• Start date: April 2007
• Est. completion date: December 2011

Study information

• Verified date: April 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioma
• Medulloblastoma

Intervention

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

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Herston	Queensland
Australia	Pfizer Investigational Site	Parkville	Victoria
Australia	Pfizer Investigational Site	Westmead	New South Wales
Belgium	Pfizer Investigational Site	Gent
Belgium	Pfizer Investigational Site	Leuven
Denmark	Pfizer Investigational Site	Aarhus N
Denmark	Pfizer Investigational Site	Koebenhavn OE
France	Pfizer Investigational Site	Angers
France	Pfizer Investigational Site	Bordeaux
France	Pfizer Investigational Site	Lille
France	Pfizer Investigational Site	Lyon Cedex 08
France	Pfizer Investigational Site	Marseille
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Villejuif
Italy	Pfizer Investigational Site	Padova
Poland	Pfizer Investigational Site	Warszawa
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	El Palmar	Murcia
Spain	Pfizer Investigational Site	Esplugues de Llobregat	Barcelona
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Sevilla
Spain	Pfizer Investigational Site	Valencia
United Kingdom	Pfizer Investigational Site	Birmingham
United Kingdom	Pfizer Investigational Site	Leeds
United Kingdom	Pfizer Investigational Site	Manchester
United Kingdom	Pfizer Investigational Site	Newcastle Upon Tyne
United Kingdom	Pfizer Investigational Site	Nottingham
United Kingdom	Pfizer Investigational Site	Soouthampton	Hampshire
United Kingdom	Pfizer Investigational Site	Sutton

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Objective Response of Complete Response or Partial Response	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.	Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)	No
Secondary	Percentage of Participants With Objective Response of Complete Response or Partial Response, Investigator's Assessment	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.	Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)	No
Secondary	Duration of Response	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.	Baseline to Date of Tumor Response (Up to 1 Year)	No
Secondary	Time to Treatment Failure (TTF)	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.	Baseline to Date of Treatment Failure (Up to 1 Year)	No
Secondary	Time to Tumor Progression (TTP)	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.	Baseline to Date of Progression (Up to 1 Year)	No
Secondary	Overall Survival (OS)	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.	Baseline to Date of Death (Up to 1 Year After Treatment)	No

External Links

•   To obtain contact information for a study center near you, click here.