Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047177
Status:
COMPLETED
Last Update Posted:
2009-10-15
First Post:
2002-10-03
Brief Title:
Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma Supratentorial Primitive Neuroectodermal Tumor or Atypical Teratoid Rhabdoid Tumor
Sponsor:
Pediatric Brain Tumor Consortium
Organization:
Pediatric Brain Tumor Consortium
Study Overview
Official Title:
A Phase II Study of Oxaliplatin in Children With Recurrent or Refractory Medulloblastoma Supratentorial Primitive Neuroectodermal Tumors and Atypical Teratoid Rhabdoid Tumors
Status:
COMPLETED
Status Verified Date:
2009-10
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of oxaliplatin in treating children who have recurrent or refractory medulloblastoma supratentorial primitive neuroectodermal or atypical teratoid rhabdoid tumor
PURPOSE Phase II trial to study the effectiveness of oxaliplatin in treating children who have recurrent or refractory medulloblastoma supratentorial primitive neuroectodermal or atypical teratoid rhabdoid tumor
Detailed Description:
OBJECTIVES
Estimate the objective response rate to oxaliplatin in pediatric patients with recurrent or refractory medulloblastoma at first progression
Estimate the objective response rate to oxaliplatin in pediatric patients with recurrent or refractory medulloblastoma at second or later relapse
Estimate the objective response rate to oxaliplatin in pediatric patients with recurrent or refractory supratentorial primitive neuroectodermal tumor or atypical teratoid rhabdoid tumor
Describe the pharmacokinetics of this drug in these patients
OUTLINE This is a multicenter study Patients are stratified according to tumor type medulloblastoma measurable disease at first relapse vs positive cerebrospinal fluid or linear leptomeningeal disease vs measurable disease at second or later progression vs supratentorial primitive neuroectodermal tumor vs atypical teratoid rhabdoid tumor
Patients receive oxaliplatin IV over 2 hours on day 1 Treatment repeats every 21 days for up to 17 courses 1 year in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 65 patients will be accrued for this study within 15-28 years
Estimate the objective response rate to oxaliplatin in pediatric patients with recurrent or refractory medulloblastoma at first progression
Estimate the objective response rate to oxaliplatin in pediatric patients with recurrent or refractory medulloblastoma at second or later relapse
Estimate the objective response rate to oxaliplatin in pediatric patients with recurrent or refractory supratentorial primitive neuroectodermal tumor or atypical teratoid rhabdoid tumor
Describe the pharmacokinetics of this drug in these patients
OUTLINE This is a multicenter study Patients are stratified according to tumor type medulloblastoma measurable disease at first relapse vs positive cerebrospinal fluid or linear leptomeningeal disease vs measurable disease at second or later progression vs supratentorial primitive neuroectodermal tumor vs atypical teratoid rhabdoid tumor
Patients receive oxaliplatin IV over 2 hours on day 1 Treatment repeats every 21 days for up to 17 courses 1 year in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 65 patients will be accrued for this study within 15-28 years
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-010 | None | None | None |