CERN 08-01: A Phase II Study of Bevacizumab and Lapatinib in Children With Recurrent or Refractory Ependymoma
What is the purpose of this study?
To estimate the sustained objective response rates [complete response (CR) plus partial response (PR)] to lapatinib 900 mg/m2/dose twice a day, bevacizumab 10 mg/kg IV every 2 weeks in children with recurrent or refractory ependymoma.
Who can participate?
Age: Patient must be < or = 21 years of age.
- Tumor: Patients must have recurrent or refractory intracranial ependymoma, ependymoblastoma or subependymoma (including myxopapillary and clear cell and anaplastic ependymoma) with a histological diagnosis from either the initial presentation or the time of recurrence. Scrolls or paraffin embedded block from available prior brain tumor specimens must be submitted within 60 days of enrollment for central analysis.
- Patients must have measurable disease, defined as at least one measurable lesion that can be accurately measured in 2 planes. Diffuse leptomeningeal involvement will not be considered measurable disease.
- Patients may have a maximum of two prior salvage chemotherapy regimens after radiotherapy.
- Neurological Deficits: Patients with neurological deficits should have deficits that are stable or improving for a minimum of 1 week prior to registration.
- Cancer - Brain and Spinal Tumors
Who should I contact for more information?
Cincinnati Children’s Hospital Medical Center
Cancer and Blood Diseases Institute
3333 Burnet Ave., Cincinnati, OH 45229-3039
Where can I find additional information?