Phase I Study of Intrathecal Spartaject-Busulfan in Patients With Neoplastic Meningitis
- Determine the maximum tolerated dose of intrathecal busulfan by a limited escalation
dosage schedule in patients with recurrent or refractory leptomeningeal tumors.
- Determine the cerebrospinal fluid and serum pharmacokinetics of busulfan administered
via intralumbar or intraventricular routes in these patients.
OUTLINE: This is dose-escalation study.
Patients receive intrathecal busulfan via intralumbar or intraventricular routes twice a
week for 2 weeks (4 treatments). Any patient with objective or significant clinical response
may continue treatment by receiving the same dose once a week for 2 consecutive weeks, once
a week every other week for 3 weeks (2 treatments), and then once a month thereafter until
disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of intrathecal busulfan 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 12 weeks for 1 year or until disease progression.
PROJECTED ACCRUAL: A total of 5-20 patients will be accrued for this study within 1-2 years.
Primary Purpose: Treatment
Henry S. Friedman, MD
Duke Cancer Institute
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|