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Phase 2 Study of Nimotuzumab in Pediatric Recurrent Diffuse Intrinsic Pontine Glioma

This study is currently recruiting participants.
Verified by YM BioSciences, January 2008

Sponsored by: YM BioSciences
Information provided by: YM BioSciences
ClinicalTrials.gov Identifier: NCT00600054
  Purpose

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.


Condition Intervention Phase
Pontine Gliomas
Biological: nimotuzumab (anti EGFR humanized monoclonal antibody)
Phase II

Drug Information available for:   Epidermal Growth Factor   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Phase 2 Study of Safety and Efficacy of Nimotuzumab (TheraCIM®) in Pediatric Patients With Recurrent Diffuse Intrinsic Pontine Glioma

Further study details as provided by YM BioSciences:

Primary Outcome Measures:
  • To determine the objective response rate [ Time Frame: To determine response rate on week 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment:   40
Study Start Date:   October 2007
Estimated Study Completion Date:   December 2009
Estimated Primary Completion Date:   December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Single arm: Experimental Biological: nimotuzumab (anti EGFR humanized monoclonal antibody)
150 mg/m2 I.V. (1mg/ml, over 30 to 60 minutes). 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.

  Eligibility
Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600054

Contacts
Contact: Igor Sherman, PhD     905 629-9761 ext 228     isherman@ymbiosciences.com    
Contact: Jose Cevallos, MD     905 629-9761 ext 233     jcevallos@ymbiosciences.com    

Locations
United States, Colorado
Children's Hospital/University of Colorado     Recruiting
      Denver, Colorado, United States, 80045
      Contact: Lia Gore, MD     720-777-4159     lia.gore@uchsc.edu    
      Contact: Pamela Bowry, RN     720 777-4159     bowry.pamela@tchden.org    
      Principal Investigator: Lia Gore, MD            
      Sub-Investigator: Nicholas Foreman, MD            
United States, New York
NYU Medical Center, Hassenfeld Clinic     Recruiting
      New York, New York, United States, 10016
      Contact: Jeffrey Allen, MD     212-263-8400     jeffrey.allen@NYUMC.org    
      Contact: Erin Harnett, RN     212 263-9935     Erin.Harnett@nyumc.org    
      Principal Investigator: Jeffrey Allen, MD            
United States, Tennessee
Vanderbilt University Medical Center     Recruiting
      Nashville, Tennessee, United States, 37232-6310
      Contact: John F. Kuttesch, MD, Ph.D.     615-322-0333     John.Kuttesch@Vanderbilt.Edu    
      Contact: Kathleen M VonWahlde, RN     615 322-0333     kate.vonwahlde@Vanderbilt.Edu    
      Principal Investigator: John F. Kuttesch, MD, Ph.D.            
United States, Texas
The University of Texas/M.D. Anderson Cancer Center     Recruiting
      Houston, Texas, United States, 77030
      Contact: Johannes Wolff, MD     713-794-4963     jwolff@mdanderson.org    
      Contact: Margaret Nagel, RN     713 745-3131     MNagel@mdanderson.org    
      Principal Investigator: Johannes Wolff, MD            
Canada, Alberta
Alberta Children's Hospital     Recruiting
      Calgary, Alberta, Canada, T3B 6A8
      Contact: Aru Narendran, MD     403 955-7641     anarendr@ucalgary.ca    
      Contact: Janice Hamilton, RN     403 955-7641     Janice.Hamilton@calgaryhealthregion.ca    
      Principal Investigator: Aru Narendran, MD            
Canada, Ontario
The Hospital For Sick Children     Recruiting
      Toronto, Ontario, Canada, M5G 1X8
      Contact: Ute Bartels, MD     416 813-5249     ute.bartels@sickkids.ca    
      Contact: Janet Gammon, RN     416 813-5249     janet.gammon@sickkids.ca    
      Principal Investigator: Dr. Eric Bouffet, MD            
      Sub-Investigator: Ute Bartels, MD            
      Principal Investigator: Sylvain Baruchel, MD            

Sponsors and Collaborators
YM BioSciences

Investigators
Study Director:     Igor Sherman, PhD     YM BioSciences Inc.    
Study Director:     Paul Keane, 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    
  More Information


Responsible Party:   YM BioSciences Inc. ( Dr. Igor Sherman )
Study ID Numbers:   YMB1000-013
First Received:   January 11, 2008
Last Updated:   April 22, 2008
ClinicalTrials.gov Identifier:   NCT00600054
Health Authority:   United States: Food and Drug Administration;   Canada: Health Canada

Keywords provided by YM BioSciences:
Diffuse intrinsic pontine glioma  
Common Terminology Criteria  
Epidermal Growth factor receptor  
Human antihuman antibody  
pharmacokinetics
monoclonal antibody
Informed Consent Form

Study placed in the following topic categories:
Antibodies, Monoclonal
Neuroectodermal Tumors
Antibodies
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 28, 2008




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