Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase I Study of SU5416 in Pediatric Patients With Recurrent or Progressive Poor Prognosis Brain Tumors
RATIONALE: SU5416 may stop the growth of brain cancer cells by stopping blood flow to the
tumor.
PURPOSE: Phase I trial to study the safety of delivering SU5416 in children who have
recurrent or progressive brain tumors.
OBJECTIVES: I. Determine the qualitative and quantitative toxicity of SU5416 in pediatric
patients with recurrent or progressive brain tumors. II. Determine the acute and chronic
dose-limiting toxicity and cumulative toxicity of this regimen in these patients. III.
Determine the maximum tolerated dose and pharmacokinetics of this regimen in this patient
population. IV. Determine the effects of hepatic enzyme-inducing drugs, such as
anticonvulsant agents, on the pharmacokinetics of this regimen in these patients. V.
Determine the efficacy, in a preliminary manner, of this regimen in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to
concurrent use of enzyme-inducing anticonvulsant drugs (yes vs no drugs or modest-induction
drugs). Patients receive SU5416 IV over 1 hour twice a week for 6 weeks. Treatment repeats
every 6 weeks for 17 courses (approximately 2 years) in the absence of unacceptable toxicity
or disease progression. Cohorts of 3-6 patients in each stratum receive escalating doses of
SU5416 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then
annually for 5 years.
PROJECTED ACCRUAL: A total of 50 patients (25 per stratum) will be accrued for this study.
;
Endpoint Classification: Safety Study, Primary Purpose: Treatment
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