Phase I Study of Intrathecal Spartaject-Busulfan in Children With Neoplastic Meningitis
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.
Interventional
Endpoint Classification: Safety Study, Primary Purpose: Treatment
Toxicities of IT administered busulfan in children and adolescents with refractory CNS malignancies
Yes
Sri Gururangan, MD
Study Chair
Duke University
United States: Food and Drug Administration
CDR0000068178
NCT00006246
November 2000
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Children's National Medical Center | Washington, District of Columbia 20010-2970 |
Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |