Sponsor study identifier
interventional
44
3 countries
13
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2010
Actual (reported)Study Completion
December 2010
Actual (reported)This is a phase 2, single-arm, multi-center study, with a safety review component, designed to evaluate the efficacy and safety of nimotuzumab in approximately 44 patients with recurrent diffuse intrinsic pontine glioma (DIPG) following one previous regimen for their disease. Patients must be diagnosed with radiologically verified recurrent diffuse intrinsic pontine glioma that is measurable in at least two dimensions. Patients are eligible without histologic confirmation. Treatment regimen will consist of two phases-induction and consolidation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
January 11, 2008
Actual (reported)January 24, 2008
Actual (reported)March 2010
Actual (reported)December 2010
Actual (reported)To determine the objective response rate
To determine response rate on week 18
To evaluate the safety profile of single agent nimotuzumab in this population
safety will be evaluated after each study drug administration
150 mg/m2 I.V. Induction phase: infusions once a week for 8 weeks. Consolidation phase: infusions once every 2 weeks for 10 weeks. Patients may then continue on the consolidation regimen of nimotuzumab, until disease progression or the occurrence of unacceptable toxicity.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Children's Hospital/University of Colorado
Denver, Colorado, 80045, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
University of Florida Shands Cancer Center
Gainesville, Florida, 32611, United States
Children's Memorial Hospital
Chicago, Illinois, 60614-3394, United States
The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins
Baltimore, Maryland, 21287, United States
NYU Medical Center, Hassenfeld Clinic
New York, New York, 10016, United States
Memorial Sloan-Kettering Cancer Center
Eric Bouffet, MD
The Hospital for Sick Children
Ute Bartels, MD
The Hospital for Sick Children
Sylvain Baruchel, MD
The Hospital for Sick Children
44 participants (actual enrollment reported by the registry).
First Submitted
January 11, 2008
First Posted
January 24, 2008
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
New York, New York, 10065, United States
University of Rochester Medical Center, Strong Memorial Hospital
Rochester, New York, 10016, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-6310, United States
The University of Texas/M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8, Canada
The Hospital For Sick Children
Toronto, Ontario, M5G 1X8, Canada
The Chaim Sheba Medical Center
Tel Litwinsky, Tel-Hashomer, 52621, Israel
Primary Completion
March 2010
Actual (reported)Study Completion
December 2010
Actual (reported)Last Updated
July 6, 2011
Record last verified: 2011-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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