Medpedia

• Recurrent Diffuse Pontine Gliomas

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

• Biological: nimotuzumab (anti EGFR humanized monoclonal antibody)
  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.

• To determine the objective response rate
  To determine response rate on week 18
  Safety Issue: No
• To evaluate the safety profile of single agent nimotuzumab in this population
  safety will be evaluated after each study drug administration
  Safety Issue: Yes

• Leonardo Viana, MD
  Study Director, YM BioSciences Inc.
• Eric Bouffet, MD
  Principal Investigator, The Hospital for Sick Children
• Ute Bartels, MD
  Principal Investigator, The Hospital for Sick Children
• Sylvain Baruchel, MD
  Principal Investigator, The Hospital for Sick Children

• The Chaim Sheba Medical Center
  Tel-Hashomer, 52621, Israel
  Active, not recruiting
• The Hospital For Sick Children
  Toronto, Ontario, M5G 1X8, Canada
  Active, not recruiting
• Alberta Children's Hospital
  Calgary, Alberta, T3B 6A8, Canada
  Active, not recruiting
• The University of Texas/M.D. Anderson Cancer Center
  Houston, Texas, 77030, United States
  Active, not recruiting
• Vanderbilt University Medical Center
  Nashville, Tennessee, 37232-6310, United States
  Active, not recruiting
• University of Rochester Medical Center, Strong Memorial Hospital
  Rochester, New York, 10016, United States
  Active, not recruiting
• Memorial Sloan-Kettering Cancer Center
  New York, New York, 10065, United States
  Active, not recruiting
• NYU Medical Center, Hassenfeld Clinic
  New York, New York, 10016, United States
  Active, not recruiting
• The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins
  Baltimore, Maryland, 21287, United States
  Active, not recruiting
• Children's Memorial Hospital
  Chicago, Illinois, 60614-3394, United States
  Active, not recruiting
• University of Florida Shands Cancer Center
  Gainesville, Florida, 32611, United States
  Active, not recruiting
• Children's National Medical Center
  Washington, District of Columbia, 20010, United States
  Active, not recruiting

• YM BioSciences
  Lead Sponsor
• Canada: Health Canada
• United States: Food and Drug Administration