Clinical Trial: Clinical Trial Evaluating the Combination of Vandetanib and Dasatinib During and After Radiation Therapy (RT) in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase I Study of the Combination of Vandetanib and Dasatinib Administered During and After Radiation Therapy in Children With Diffuse Intrinsic Pontine Glioma
Brief Summary: This is a Phase I clinical trial evaluating the combination of vandetanib and dasatinib during and after radiation therapy (RT) in children with newly diagnosed diffuse intrinsic pontine glioma (DIPG).
Detailed Summary: This trial will estimate the maximum safe dose of vandetanib and dasatinib which can be administered during the 6 weeks of local RT in children with newly diagnosed DIPG.
Sponsor: St. Jude Children's Research Hospital
Current Primary Outcome: To estimate the maximum tolerated dose (MTD) of the combination of vandetanib and dasatinib administered concurrently with RT in pediatric research participants with newly diagnosed DIPG [ Time Frame: April 2012 ]
Original Primary Outcome: To estimate the maximum tolerated dose (MTD) of the combination of vandetanib and dasatinib administered concurrently with RT in pediatric research participants with newly diagnosed DIPG [ Time Frame: July 2012 ]
Current Secondary Outcome:
- To determine the toxicities associated with the chronic use of vandetanib and dasatinib [ Time Frame: July 2012 ]
- To characterize the pharmacokinetics of vandetanib and dasatinib in pediatric research participants [ Time Frame: July 2012 ]
- To evaluate the influence of specific polymorphisms (e.g., CYP3A4/5) on the pharmacokinetics of vandetanib and dasatinib administered in combination [ Time Frame: July 2012 ]
- To explore the association between plasma angiogenic factors and response to current therapy [ Time Frame: July 2012 ]
- To evaluate the pharmacodynamics of dasatinib in target receptors and pathways in peripheral mononuclear cells [ Time Frame: July 2012 ]
- To describe the research participants' and parents' perspective of the quality of life of children with newly diagnosed DIPG enrolled on this phase I trial [ Time Frame: July 2012 ]
- To describe the quality of life of parents of pediatric research participants with newly diagnosed DIPG enrolled on this phase I trial [ Time Frame: July 2012 ]
Original Secondary Outcome: Same as current
Information By: St. Jude Children's Research Hospital
Dates:
Date Received: October 15, 2009
Date Started: October 2009
Date Completion:
Last Updated: April 3, 2015
Last Verified: April 2015