Vandetanib and Radiation Therapy in Treating Young Patients With Newly Diagnosed Diffuse Brainstem Glioma

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial is studying the side effects and best dose of vandetanib when given together with radiation therapy in treating young patients with newly diagnosed diffuse brain stem glioma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital

Criteria

• Diagnosis of 1 of the following:

• Diffuse brainstem glioma

• High-grade glioma originating from brainstem

• Age must be greater than or equal to 2 years and less than 21 years

• Newly diagnosed disease

• Lansky OR Karnofsky performance status 40-100%

• ANC ≥ 1,000/mm³

• Platelet count ≥ 100,000/mm³ (transfusion independent)

• Hemoglobin ≥ 8 g/dL (transfusion allowed)

• Bilirubin < 1.5 times upper limit of normal (ULN) for age

• ALT < 5 times ULN

• Albumin ≥ 2 g/dL

• Creatinine < 2 times ULN for age OR glomerular filtration rate > 70 mL/min

• QTc interval < 450 msec by EKG

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception