Phase I Trial of Vandetanib (ZD6474, ZACTIMA) With Concurrent Radiation in Treatment of Newly Diagnosed Brainstem Glioma
Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for
cell growth. Specialized radiation therapy that delivers a high dose of radiation directly
to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving
vandetanib together with radiation therapy may kill more tumor cells.
Patients undergo conformal radiotherapy once daily, 5 days a week, for 6 weeks. Patients
also receive oral vandetanib once daily beginning on the same day as radiotherapy and
continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of vandetanib until the maximum tolerated
dose (MTD) is determined.
Blood samples are collected periodically for pharmacokinetic studies, polymorphism analysis
(e.g., CYP3A4/5), and immunological laboratory methods (e.g., western blot assay). Imaging
studies are also conducted periodically.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To estimate the maximum tolerated dose (MTD) and to determine the dose-limiting toxicity (DLT) of vandetanib administered concurrently with radiation therapy (RT) in pediatric patients with newly diagnosed diffuse brainstem glioma.
Alberto Broniscer, MD
St. Jude Children's Research Hospital
United States: Food and Drug Administration
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