Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006246
Status:
COMPLETED
Last Update Posted:
2009-10-07
First Post:
2000-09-11
Brief Title:
Busulfan in Treating Children and Adolescents With Refractory CNS Cancer
Sponsor:
Pediatric Brain Tumor Consortium
Organization:
Pediatric Brain Tumor Consortium
Study Overview
Official Title:
Phase I Study of Intrathecal Spartaject-Busulfan in Children With Neoplastic Meningitis
Status:
COMPLETED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PBTC-004 | None | None | None |