Combination of Irinotecan and Temozolomide in Children With Brain Tumors.

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Irinotecan

Temozolomide

About this trial

This is an interventional treatment trial for Glioma

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Temozolomide + Irinotecan

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT00404495

First Posted

November 27, 2006

Last Updated

April 16, 2012

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00404495

Brief Title

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

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioma, Medulloblastoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

83 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Temozolomide + Irinotecan

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Irinotecan

Intervention Description

Irinotecan 10 mg/m^2 per day on days 1-5 and days 8-12 in repeated 3 week cycles

Intervention Type

Drug

Intervention Name(s)

Temozolomide

Intervention Description

Temozolomide 100-125 mg/m^2 daily on days 1-5 in repeated 3 week cycles

Primary Outcome Measure Information:

Title

Percentage of Participants With Objective Response of Complete Response or Partial Response

Description

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.

Time Frame

Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)

Secondary Outcome Measure Information:

Title

Percentage of Participants With Objective Response of Complete Response or Partial Response, Investigator's Assessment

Description

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.

Time Frame

Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)

Title

Duration of Response

Description

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.

Time Frame

Baseline to Date of Tumor Response (Up to 1 Year)

Title

Time to Treatment Failure (TTF)

Description

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 Frame

Baseline to Date of Treatment Failure (Up to 1 Year)

Title

Time to Tumor Progression (TTP)

Description

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.

Time Frame

Baseline to Date of Progression (Up to 1 Year)

Title

Overall Survival (OS)

Description

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.

Time Frame

Baseline to Date of Death (Up to 1 Year After Treatment)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Pfizer Investigational Site

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Pfizer Investigational Site

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3052

Country

Australia

Facility Name

Pfizer Investigational Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Pfizer Investigational Site

City

Koebenhavn OE

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Pfizer Investigational Site

City

Angers

ZIP/Postal Code

49000

Country

France

Facility Name

Pfizer Investigational Site

City

Bordeaux

ZIP/Postal Code

33000

Country

France

Facility Name

Pfizer Investigational Site

City

Lille

ZIP/Postal Code

59020

Country

France

Facility Name

Pfizer Investigational Site

City

Lyon Cedex 08

ZIP/Postal Code

69373

Country

France

Facility Name

Pfizer Investigational Site

City

Marseille

ZIP/Postal Code

13385

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

ZIP/Postal Code

75005

Country

France

Facility Name

Pfizer Investigational Site

City

Villejuif

ZIP/Postal Code

94805

Country

France

Facility Name

Pfizer Investigational Site

City

Padova

ZIP/Postal Code

35100

Country

Italy

Facility Name

Pfizer Investigational Site

City

Warszawa

ZIP/Postal Code

04-730

Country

Poland

Facility Name

Pfizer Investigational Site

City

Esplugues de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08950

Country

Spain

Facility Name

Pfizer Investigational Site

City

El Palmar

State/Province

Murcia

ZIP/Postal Code

30120

Country

Spain

Facility Name

Pfizer Investigational Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Pfizer Investigational Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Pfizer Investigational Site

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Pfizer Investigational Site

City

Soouthampton

State/Province

Hampshire

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Birmingham

ZIP/Postal Code

B4 6NH

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Manchester

ZIP/Postal Code

M27 4HA

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Newcastle Upon Tyne

ZIP/Postal Code

NE1 4LP

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Nottingham

ZIP/Postal Code

NG7 2UH

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Sutton

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5961166&StudyName=Combination%20of%20Irinotecan%20and%20Temozolomide%20in%20Children%20with%20Brain%20Tumors.

Description

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

Glioma, Medulloblastoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial