Combination of Irinotecan and Temozolomide in Children With Brain Tumors.

NCT00404495 | Completed Phase 2 Results

• 1 other identifier: A5961166
• Study Type: interventional
• Target: 83
• Locations: 8 countries
• Sites: 29

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.

Conditions

Glioma; Medulloblastoma

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (5)

• 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)

• Duration of Response

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

• Time to Treatment Failure (TTF)

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

• Time to Tumor Progression (TTP)

  Baseline to Date of Progression (Up to 1 Year)

• Overall Survival (OS)

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

Study Arms (1)

Temozolomide + Irinotecan

EXPERIMENTAL

Drug: Irinotecan; Drug: Temozolomide

Interventions

Irinotecan DRUG

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

Temozolomide + Irinotecan

Temozolomide DRUG

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

Temozolomide + Irinotecan

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of brainstem glioma
• Concurrent administration of any other anti-tumor therapy
• Pre-existing uncontrolled diarrhea

Sponsors & Collaborators

• Pfizer: lead

Study Sites (29)

Pfizer Investigational Site

Westmead, New South Wales, 2145, Australia

Location

Pfizer Investigational Site

Herston, Queensland, 4029, Australia

Location

Pfizer Investigational Site

Parkville, Victoria, 3052, Australia

Location

Pfizer Investigational Site

Ghent, 9000, Belgium

Location

Pfizer Investigational Site

Leuven, 3000, Belgium

Location

Pfizer Investigational Site

Aarhus N, 8200, Denmark

Location

Pfizer Investigational Site

Koebenhavn OE, 2100, Denmark

Location

Pfizer Investigational Site

Angers, 49000, France

Location

Pfizer Investigational Site

Bordeaux, 33000, France

Location

Pfizer Investigational Site

Lille, 59020, France

Location

Pfizer Investigational Site

Lyon, 69373, France

Location

Pfizer Investigational Site

Marseille, 13385, France

Location

Pfizer Investigational Site

Paris, 75005, France

Location

Pfizer Investigational Site

Villejuif, 94805, France

Location

Pfizer Investigational Site

Padua, 35100, Italy

Location

Pfizer Investigational Site

Warsaw, 04-730, Poland

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08035, Spain

Location

Pfizer Investigational Site

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28009, Spain

Location

Pfizer Investigational Site

El Palmar, Murcia, 30120, Spain

Location

Pfizer Investigational Site

Seville, Sevilla, 41013, Spain

Location

Pfizer Investigational Site

Valencia, Valencia, 46026, Spain

Location

Pfizer Investigational Site

Soouthampton, Hampshire, SO16 6YD, United Kingdom

Location

Pfizer Investigational Site

Birmingham, B4 6NH, United Kingdom

Location

Pfizer Investigational Site

Leeds, LS9 7TF, United Kingdom

Location

Pfizer Investigational Site

Manchester, M27 4HA, United Kingdom

Location

Pfizer Investigational Site

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Pfizer Investigational Site

Nottingham, NG7 2UH, United Kingdom

Location

Pfizer Investigational Site

Sutton, SM2 5PT, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Glioma; Medulloblastoma

Interventions

Irinotecan; Temozolomide

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

This study had one treatment arm but two distinct cohorts with different diagnostics and treatment durations.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2006
• First Posted: November 28, 2006
• Study Start: April 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 18, 2012
• Results First Posted: February 17, 2012

Record last verified: 2012-04

Locations

GB (7); PL (1); DK (2); FR (7); BE (2); IT (1); ES (6); AU (3)