A Randomized Phase II Trial of Bevacizumab to Control Brain Radiation Damage
I. Determine to what extent bevacizumab can reduce active radiation toxicity to the CNS in
patients who have undergone cranial irradiation for primary brain neoplasm, meningioma, or
head and neck cancer.
I. Determine to what extent this drug can reduce dexamethasone dependence in these patients.
II. Determine to what extent this drug can improve neurologic function in these patients.
III. Determine to what extent this drug can improve quality of life of these patients.
OUTLINE: This is a randomized, placebo-controlled, crossover, double-blind study. Patients
are randomized to 1 of 2 treatment arms.
ARM I: Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every
3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo IV over 30-90 minutes on day 1. Treatment repeats every 3
weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Patients in arm II who have failed to respond to treatment at 6 or 12 weeks may cross over
to arm I and receive 2 courses of bevacizumab as in arm I. Patients in arm I (including
crossover patients) who have responded to treatment may receive 2 additional courses of
Patients undergo MRI after courses 2 and 4.
Quality of life and neurologic function are assessed at baseline, periodically during study
treatment, and at 12 and 24 weeks after completion of study treatment.
After completion of study treatment, patients are followed at 12 and 24 weeks.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
Number of Participants With Response ( > 25% Reduction in T2 Flair) From Baseline to Evaluation at 6 Weeks Post Treatment
Change in magnetic resonance imaging (MRI) from baseline to evaluation at 6 weeks for participants where MRI changes are based on the size of edema (T2 FLAIR) and Gd-contrast enhancement (lesion diameter and perfusion/dynamic). A 25% reduction in T2 flair volume constitutes a response for study.
Baseline to 12 weeks
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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