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Phase 2 Study of Nimotuzumab in Pediatric Recurrent Diffuse Intrinsic Pontine Glioma
This study is currently recruiting participants.
Study NCT00600054   Information provided by YM BioSciences
First Received: January 11, 2008   Last Updated: February 5, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

January 11, 2008
February 5, 2009
October 2007
To determine the objective response rate [ Time Frame: To determine response rate on week 18 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00600054 on ClinicalTrials.gov Archive Site
To evaluate the safety profile of single agent nimotuzumab in this population [ Time Frame: safety will be evaluated after each study drug administration ] [ Designated as safety issue: Yes ]
Same as current
 
Phase 2 Study of Nimotuzumab in Pediatric Recurrent Diffuse Intrinsic Pontine Glioma
Phase 2 Study of Safety and Efficacy of Nimotuzumab (TheraCIM®) in Pediatric Patients With Recurrent Diffuse Intrinsic Pontine Glioma

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.

 
Phase II
Interventional
Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Recurrent Diffuse Pontine Gliomas
Biological: nimotuzumab (anti EGFR humanized monoclonal antibody)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
40
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed written informed consent
  • Patients with recurrent, diffuse intrinsic pontine gliomas
  • Patients should have had 2 of the following 3 neurological symptoms: cranial nerve deficit, long tract signs, ataxia and a onset prior to initial diagnosis < 6 months.
  • Evidence of disease progression
  • Have a Lansky or Karnofsky Performance Status of > 40
  • Be between the age >3 years to < 18 years of age
  • Have a tumor that is measurable radiologically
  • For female patients of childbearing age: presence of a negative pregnancy test within 7 days prior to day 0.
  • Use of effective contraception
  • Adequate hematological, renal, and hepatic function

Exclusion Criteria:

  • A history of prior use of EGFR-targeting agents (monoclonal antibodies, tyrosine kinase inhibitors)
  • More than one line of treatment
  • Patients with disseminated disease are not eligible
  • Had radiation therapy completed within 12 weeks of enrollment
  • Previous chemotherapy completed < 2 weeks prior to enrollment
  • If female, is pregnant or lactating
  • Has other existing serious medical conditions
  • Has any condition, therapy, or medical condition, which, in the opinion of the attending physician could represent a risk for the patient or adversely affect the study objectives
  • Is currently taking or planning to take other investigational drugs during the study
  • Known contraindications against antibodies
Both
3 Years to 18 Years
No
Contact: Leonardo Viana, MD 905 629-9761 ext 240 lviana@ymbiosciences.com
Contact: Jose Cevallos, MD 905 629-9761 ext 233 jcevallos@ymbiosciences.com
United States,   Canada,   Israel
 
 
NCT00600054
Dr. Leonardo Viana, YM BioSciences Inc.
 
YM BioSciences
 
Study Director: Leonardo Viana, MD YM BioSciences Inc.
Principal Investigator: Eric Bouffet, MD The Hospital for Sick Children
Principal Investigator: Ute Bartels, MD The Hospital for Sick Children
Principal Investigator: Sylvain Baruchel, MD The Hospital for Sick Children
YM BioSciences
February 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.