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.

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