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

Study Overview
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Brief Summary
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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.

Official Title
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Phase 2 Study of Safety and Efficacy of Nimotuzumab (TheraCIM®) in Pediatric Patients With Recurrent Diffuse Intrinsic Pontine Glioma

Conditions
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Recurrent Diffuse Pontine Gliomas

Intervention / Treatment
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* Biological: nimotuzumab (anti EGFR humanized monoclonal antibody)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br> | Biological: nimotuzumab (anti EGFR humanized monoclonal antibody)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the objective response rate |  | To determine response rate on week 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety profile of single agent nimotuzumab in this population |  | safety will be evaluated after each study drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diffuse intrinsic pontine glioma, Common Terminology Criteria, Epidermal Growth factor receptor, Human antihuman antibody, pharmacokinetics, monoclonal antibody, Informed Consent Form