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

Completed · Phase 2

Conditions studied: Recurrent Diffuse Pontine Gliomas

In brief

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.

Key facts

Study ID

NCT00600054

Run by

YM BioSciences

People needed

44

Starts

2007-10-01

Expected to finish

2010-12-01

Last updated by the study team

2011-07-06

Who can join

Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital/University of Colorado — Denver, Colorado, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• University of Florida Shands Cancer Center — Gainesville, Florida, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins — Baltimore, Maryland, United States
• NYU Medical Center, Hassenfeld Clinic — New York, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• University of Rochester Medical Center, Strong Memorial Hospital — Rochester, New York, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• The University of Texas/M.D. Anderson Cancer Center — Houston, Texas, United States
• Alberta Children's Hospital — Calgary, Alberta, Canada
• The Hospital For Sick Children — Toronto, Ontario, Canada
• The Chaim Sheba Medical Center — Tel Litwinsky, Tel-Hashomer, Israel

Full record on ClinicalTrials.gov

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