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

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