Phase 2 Study of Safety and Efficacy of Nimotuzumab (TheraCIM®) in Pediatric Patients With 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