Trials / Completed
CompletedNCT00006246
Busulfan in Treating Children and Adolescents With Refractory CNS Cancer
Phase I Study of Intrathecal Spartaject-Busulfan in Children With Neoplastic Meningitis
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Pediatric Brain Tumor Consortium · Network
- Sex
- All
- Age
- 3 Years – 21 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Brain and Central Nervous System Tumors
- Childhood Germ Cell Tumor
- Leukemia
- Lymphoma
- Metastatic Cancer
- Retinoblastoma
- Sarcoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | busulfan |
Timeline
- Start date
- 2000-11-01
- Primary completion
- 2003-05-01
- First posted
- 2003-01-27
- Last updated
- 2009-10-07
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00006246. Inclusion in this directory is not an endorsement.