Phase 2 Study of Nimotuzumab in Pediatric Recurrent Diffuse Intrinsic Pontine Glioma
- Conditions
- Recurrent Diffuse Pontine Gliomas
- Interventions
- Biological: nimotuzumab (anti EGFR humanized monoclonal antibody)
- Registration Number
- NCT00600054
- Lead Sponsor
- YM BioSciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm nimotuzumab (anti EGFR humanized monoclonal antibody) -
- Primary Outcome Measures
Name Time Method To determine the objective response rate To determine response rate on week 18
- Secondary Outcome Measures
Name Time Method To evaluate the safety profile of single agent nimotuzumab in this population safety will be evaluated after each study drug administration
Trial Locations
- Locations (13)
Children's Hospital/University of Colorado
🇺🇸Denver, Colorado, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
University of Florida Shands Cancer Center
🇺🇸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
The University of Texas/M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
The Hospital For Sick Children
🇨🇦Toronto, Ontario, Canada
The Chaim Sheba Medical Center
🇮🇱Tel-Hashomer, Israel
University of Rochester Medical Center, Strong Memorial Hospital
🇺🇸Rochester, New York, United States