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

YM BioSciences

Status and phase: Completed; Phase 2

Conditions: Recurrent Diffuse Pontine Gliomas

Treatments: Biological: nimotuzumab (anti EGFR humanized monoclonal antibody)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00600054

YMB1000-013

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Single arm

Experimental group

Treatment:

Biological: nimotuzumab (anti EGFR humanized monoclonal antibody)