Recurrent Diffuse Pontine Gliomas
Conditions
Keywords
Diffuse intrinsic pontine glioma, Common Terminology Criteria, Epidermal Growth factor receptor, Human antihuman antibody, pharmacokinetics, monoclonal antibody, Informed Consent Form
Brief summary
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.
Interventions
BIOLOGICALnimotuzumab (anti EGFR humanized monoclonal antibody)
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.
Sponsors
YM BioSciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the objective response rate | To determine response rate on week 18 |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety profile of single agent nimotuzumab in this population | safety will be evaluated after each study drug administration |
Countries
Canada, Israel, United States
Outcome results
None listed