Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase I Study of Intrathecal Spartaject-Busulfan in Patients With Neoplastic Meningitis
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Giving drugs into the thin space between the lining of the
spinal cord and brain may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of intrathecal busulfan in treating
patients with recurrent, refractory, or metastatic leptomeningeal tumors.
OBJECTIVES:
- 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
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