Protocol

PBTC22: Phase II study of Bevacizumab plus Irinotecan (Camptosar) in Children with Recurrent, Progressive, or Refractory Malignant Gliomas, Diffuse/Intrinsic Brain Stem Gliomas, Medulloblastomas, Ependymomas and Low Grade Gliomas

Diseases

Brain Tumor : Gliomas

Description

In this research study, the experimental drug, bevacizumab (also known as avastin),  along with an approved chemotherapy drug, irinotecan (also known as CPT-11 or  camptosar) will be used to study the effectiveness in children with brain tumors.
 
This study will study how well very malignant brain or spinal cord tumors will respond to bevacizumab plus irinotecan (CPT-11). Tumor growth depends on support from blood vessels that grow rapidly in and around the tumor. Bevacizumab is a drug (a monoclonal antibody) that can slow down one of the substances that promotes tumor blood vessel growth. Research studies have shown that bevacizumab is safe when used in children with recurrent solid tumors. The use of  bevacizumab in children with brain tumors is considered investigational.  Research studies in adults with malignant gliomas show that bevacizumab and irinotecan are safe and useful in controlling tumor growth.


Objectives

  • To find out how well bevacizumab and irinotecan work together in the treatment of malignant glioma or diffuse brain stem glioma
  • To learn what side effects may occur when bevacizumab and irinotecan are given together
  • To learn how your body handles bevacizumab (pharmacokinetics)
  • To learn how the tumor responds to bevacizumab by using special brain scans and blood tests

Eligibility

  • Patient is less than or equal to 21 years of age at registration
  • Adequate liver, kidney, and bone marrow function
  • No active infection or unstable medical condition prior to enrollment
  • Participant meets other requirements defined in the eligibility portion of the study
  • Participant is able to perform ordinary tasks and daily activities as defined in the study guidelines

For the current eligibility status of this clinical study, patient’s family, relatives and referring physicians may contact St. Jude Children’s Research Hospital at (901) 595-5007 or (901) 595-2544.


Contact

Robert Sanders, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN  38105  USA
TEL:  901-595-2544 or 901-595-4599
FAX:  901-595-5353

or

Tabatha E. Doyle, RN
Coordinator, Brain Tumor Program
Phone: 901-595-2544
Fax: 901-595-5353
Email: tabatha.doyle@stjude.org 

Contact us by email anytime, 24 hours a day, 7 days a week.

Amendment 10.0 dated 9.8.08, IRB approved 9.23.08


The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

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