Combination of Irinotecan and Temozolomide in Children With Brain Tumors. - Full Text View

Sponsored by:	Pfizer
Information provided by:	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:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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 ]

Estimated Enrollment:	75
Study Start Date:	April 2007
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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

Contacts

Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Show 32 Study Locations

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 Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5961166
Study First Received:	November 27, 2006
Last Updated:	August 13, 2009
ClinicalTrials.gov Identifier:	NCT00404495 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Neuroectodermal Tumors, Primitive
Irinotecan
Temozolomide
Recurrence
Brain Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal

Medulloblastoma
Neuroepithelioma
Glioma
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Alkylating Agents
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Irinotecan
Enzyme Inhibitors
Temozolomide
Pharmacologic Actions
Neuroectodermal Tumors

Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Medulloblastoma
Glioma
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Antineoplastic Agents, Phytogenic
Alkylating Agents
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 03, 2009