Study of Irinotecan and Bevacizumab With Temozolomide in Refractory/Relapsed Central Nervous System (CNS) Tumors
Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
Participant gender:
Summary
Bevacizumab, irinotecan, and temozolomide are three agents shown to have promising activity
in a variety of central nervous system tumors. No prospective studies have been published or
are currently in progress within the major consortiums with this combination of drugs. Brain
tumors are the second most common cause of cancer in pediatrics and the leading cause of
cancer death in children. For children with High Grade Gliomas or with relapsed/refractory
brain tumors, new agents in new combinations are needed. Historical data shows that newly
diagnosed high grade gliomas 5 year progression free survival is 28-42%. Recurrent malignant
gliomas median survival is 3-9 months. Recurrent medulloblastoma's 2 years survival is 9%.
This study is a phase I study designed to provide an objective observation of toxicity and
establish a maximum tolerated dose of this combination. In addition, this study will observe
the response of children with relapsed or refractory central nervous system tumors.
Phase:
Phase 1
Details
Lead Sponsor:
Johns Hopkins All Children's Hospital
Collaborators:
Brain Tumor Alliance The V Foundation V Foundation