Lymphoma Clinical Trial
Official title:
Phase I Study of Intrathecal Spartaject-Busulfan in Children With Neoplastic Meningitis
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase I trial to study the safety of delivering intrathecal busulfan in children
and adolescents who have refractory CNS cancer and to estimate the maximum tolerated dose of
this treatment regimen.
OBJECTIVES:
- Determine the qualitative and quantitative toxicities of intrathecally administered
busulfan in children and adolescents with refractory CNS malignancies.
- Determine the maximum tolerated dose of this treatment regimen in these patients.
- Determine the cerebrospinal fluid and serum pharmacokinetics of this treatment regimen
in these patients.
- Determine the efficacy of this treatment regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive intrathecal busulfan twice a week, at least 3 days apart, for 2 weeks.
Patients with complete or partial response or stable disease may continue therapy once a
week for 2 weeks, once a week every other week for 2 treatments, and then once a month
thereafter in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of busulfan until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose limiting toxicities.
Patients are followed every 3 months for the first year, every 6 months for 4 years, and
then annually for 5 years.
PROJECTED ACCRUAL: Approximately 18-24 patients will be accrued for this study over 18-38
months.
;
Endpoint Classification: Safety Study, Primary Purpose: Treatment
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