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Combination of Irinotecan and Temozolomide in Children With Brain Tumors.
This study is ongoing, but not recruiting participants.

First Received on November 27, 2006.   Last Updated on November 30, 2011   History of Changes
Sponsor: Pfizer
Information provided by (Responsible Party): Pfizer
ClinicalTrials.gov Identifier: NCT00404495
  Purpose

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.


Condition Intervention Phase
Glioma
Medulloblastoma
 Drug: Irinotecan
Drug: Temozolomide
 Phase II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Temozolomide Irinotecan U 101440E Irinotecan hydrochloride
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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. [ Time Frame: within 2 to 4 cycles depending on cohort ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to tumor progression (TTP) [ Time Frame: until progression ] [ Designated as safety issue: No ]
  • Time to treatment failure (TTF) [ Time Frame: until treatment failure ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: until death ] [ Designated as safety issue: No ]
  • The safety and tolerability of the combination of irinotecan and temozolomide [ Time Frame: 28 days after the last dose ] [ Designated as safety issue: Yes ]
  • The duration of tumor response [ Time Frame: until progression ] [ Designated as safety issue: No ]

Enrollment: 83
Study Start Date: April 2007
Estimated Study Completion Date: December 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Irinotecan
Irinotecan 10 mg/m2 per day on days 1-5 and days 8-12 in repeated 3 week cycles
Drug: Temozolomide
Temozolomide 100-125 mg/m2 daily on days 1-5 in repeated 3 week cycles

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 (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     
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00404495

Locations
Australia, New South Wales
Pfizer Investigational Site
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Pfizer Investigational Site
Herston, Queensland, Australia, 4029
Australia, Victoria
Pfizer Investigational Site
Parkville, Victoria, Australia, 3052
Belgium
Pfizer Investigational Site
Gent, Belgium, 9000
Pfizer Investigational Site
Leuven, Belgium, 3000
Denmark
Pfizer Investigational Site
Aarhus N, Denmark, 8200
Pfizer Investigational Site
Koebenhavn OE, Denmark, 2100
France
Pfizer Investigational Site
Angers, France, 49000
Pfizer Investigational Site
Bordeaux, France, 33000
Pfizer Investigational Site
Lille, France, 59020
Pfizer Investigational Site
Lyon Cedex 08, France, 69373
Pfizer Investigational Site
Marseille, France, 13385
Pfizer Investigational Site
Paris, France, 75005
Pfizer Investigational Site
Villejuif, France, 94805
Italy
Pfizer Investigational Site
Padova, Italy, 35100
Poland
Pfizer Investigational Site
Warszawa, Poland, 04-730
Spain
Pfizer Investigational Site
Esplugues de Llobregat, Barcelona, Spain, 08950
Pfizer Investigational Site
El Palmar, Murcia, Spain, 30120
Pfizer Investigational Site
Barcelona, Spain, 08035
Pfizer Investigational Site
Madrid, Spain, 28009
Pfizer Investigational Site
Sevilla, Spain, 41013
Pfizer Investigational Site
Valencia, Spain, 46026
United Kingdom
Pfizer Investigational Site
Soouthampton, Hampshire, United Kingdom, SO16 6YD
Pfizer Investigational Site
Birmingham, United Kingdom, B4 6NH
Pfizer Investigational Site
Leeds, United Kingdom, LS9 7TF
Pfizer Investigational Site
Manchester, United Kingdom, M27 4HA
Pfizer Investigational Site
Newcastle Upon Tyne, United Kingdom, NE1 4LP
Pfizer Investigational Site
Nottingham, United Kingdom, NG7 2UH
Pfizer Investigational Site
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00404495     History of Changes
Other Study ID Numbers: A5961166
Study First Received: November 27, 2006
Last Updated: November 30, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Glioma
Medulloblastoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors, Primitive
Temozolomide
Dacarbazine
Irinotecan
 Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012



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