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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
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.
Children's Hospital/University of Colorado
Denver, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Florida Shands Cancer Center
To determine the objective response rate
Time frame: To determine response rate on week 18
To evaluate the safety profile of single agent nimotuzumab in this population
Time frame: safety will be evaluated after each study drug administration
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Gainesville, Florida, United States
Children's Memorial Hospital
Chicago, Illinois, United States
The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins
Baltimore, Maryland, United States
NYU Medical Center, Hassenfeld Clinic
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
University of Rochester Medical Center, Strong Memorial Hospital
Rochester, New York, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
The University of Texas/M.D. Anderson Cancer Center
Houston, Texas, United States
...and 3 more locations