A Phase I Trial of Arsenic Trioxide in the Treatment of Infiltrating Gliomas of Childhood
- Determine the maximum tolerated dose of arsenic trioxide when administered with
radiotherapy in pediatric patients with newly diagnosed anaplastic astrocytoma,
glioblastoma multiforme, gliosarcoma, or intrinsic pontine glioma.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of arsenic trioxide (ATO).
Patients undergo radiotherapy once daily, 5 days a week, for approximately 6 weeks. Patients
concurrently receive ATO IV over 1 hour, 1-5 times weekly, for approximately 6 weeks in the
absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of ATO 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 2 months.
PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 3-36
Primary Purpose: Treatment
Maximum tolerated dose as assessed by NCI CTCAE v. 3.0 following study completion
Kenneth J. Cohen, MD, MBA
Sidney Kimmel Comprehensive Cancer Center
United States: Institutional Review Board
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|