Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005811
Status:
COMPLETED
Last Update Posted:
2013-02-21
First Post:
2000-06-02
Brief Title:
Topotecan Hydrochloride in Treating Children With Meningeal Cancer That Has Not Responded to Previous Treatment
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Intrathecal Topotecan NSC 609699 in Patients With Refractory Meningeal Malignancies
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die This phase II trial is studying how well topotecan hydrochloride works in treating children with meningeal cancer that has not responded to previous treatment
Detailed Description:
PRIMARY OBJECTIVES
I Determine the therapeutic activity of intrathecal topotecan in terms of response rate and time to central nervous system CNS progression in pediatric patients with recurrent or refractory neoplastic meningitis
II Determine the safety and toxicity of this regimen in these patients III Evaluate the concentration of matrix metalloproteinases MMPs in the cerebrospinal fluid CSF of these patients
OUTLINE Patients are stratified according to disease type acute lymphoblastic leukemia vs other leukemialymphoma vs medulloblastoma vs other solid tumors Recurrent CNS acute lymphoblastic leukemia stratum only open to accrual as of 113004
INDUCTION Patients receive topotecan hydrochloride intrathecally IT over 5 minutes twice weekly for 6 weeks
CONSOLIDATION Beginning 1 week after completion of induction patients receive topotecan hydrochloride IT over 5 minutes weekly for 4 weeks in the absence of disease progression or unacceptable toxicity
MAINTENANCE Beginning 2 weeks after completion of consolidation patients receive topotecan hydrochloride IT over 5 minutes twice monthly for 4 months and then monthly through year 1
After completion of study treatment patients are followed up monthly for 3 months every 3 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 14-77 patients will be accrued for this study
I Determine the therapeutic activity of intrathecal topotecan in terms of response rate and time to central nervous system CNS progression in pediatric patients with recurrent or refractory neoplastic meningitis
II Determine the safety and toxicity of this regimen in these patients III Evaluate the concentration of matrix metalloproteinases MMPs in the cerebrospinal fluid CSF of these patients
OUTLINE Patients are stratified according to disease type acute lymphoblastic leukemia vs other leukemialymphoma vs medulloblastoma vs other solid tumors Recurrent CNS acute lymphoblastic leukemia stratum only open to accrual as of 113004
INDUCTION Patients receive topotecan hydrochloride intrathecally IT over 5 minutes twice weekly for 6 weeks
CONSOLIDATION Beginning 1 week after completion of induction patients receive topotecan hydrochloride IT over 5 minutes weekly for 4 weeks in the absence of disease progression or unacceptable toxicity
MAINTENANCE Beginning 2 weeks after completion of consolidation patients receive topotecan hydrochloride IT over 5 minutes twice monthly for 4 months and then monthly through year 1
After completion of study treatment patients are followed up monthly for 3 months every 3 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 14-77 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000067813 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA098543 |
| P9962 | None | None | None |
| U10CA098543 | NIH | None | None |