Protocol

SJBG09: Phase I Study of the Combination of Vandetanib and Dasatinib Administered During and After Radiation Therapy in Children with Diffuse Intrinsic Pontine Glioma

Diseases

Brain Tumor : Diffuse intrinsic pontine glioma

Description

This is a Phase I clinical trial which will test the combination of the new experimental drugs vandetanib and dasatinib during and after radiation therapy in children. Vandetanib nor dasatinib have been approved by the Food and Drug Administration (FDA). Studies with vandetanib have shown that it is capable of blocking cell receptors called vascular endothelial growth factor receptor (VEGFR) and epidermal growth factor receptor (EGFR). These receptors send signals to tumor and blood vessel cells to divide and grow. Studies with dasatinib have shown that it reduces the activity of one or more proteins responsible for the uncontrolled growth of the leukemia cells which allows the bone marrow to resume production of normal red cells, white cells, and platelets. Vandetanib when combined with dasatanib may or may not have any effect on the growth of a particular brain tumor. Vandetanib and dasatanib have been tested in adults with cancer and there is evidence that vandetanib can cause some adult tumors to shrink, or at least stop growing and that dasatanib can enhance the bone marrow’s production of normal cells and platelets. This is the first time that this drug combination will be tested in children.


Objectives

  • To determine the largest dose of vandetanib combined with dasatanib that can be safely given during and after irradiation in the treatment of patients with diffuse intrinsic pontine glioma
  • To determine the good and bad effects of vandetanib when combined with dasatanib
  • To study how the body takes up and gets rid of vandetanib and dasatanib

Eligibility

  • Participants with newly diagnosed diffuse intrinsic pontine glioma
  • Participant is at least 18 months of age and less than 21 years of age
  • Participant is able to perform ordinary tasks and daily activities as defined in the study guidelines
  • Participant meets established guidelines for adequate function of the kidney, liver, and bone marrow
  • Participant is not receiving any other anticancer or experimental treatment

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) 595-2544.


Contact

Alberto Broniscer, 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: 901-595-6211
Email: tabatha.doyle@stjude.org

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

Initial version dated 6/26/09, IRB approved 10.13.09


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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