Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070525
Status:
COMPLETED
Last Update Posted:
2013-10-08
First Post:
2003-10-03
Brief Title:
Tipifarnib in Treating Young Patients With Recurrent or Progressive High-Grade Glioma Medulloblastoma Primitive Neuroectodermal Tumor or Brain Stem Glioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of R115777 Zarnestra NSC 702818 IND 58359 in Children With Recurrent or Progressive High Grade Glioma MedulloblastomaPNET or Brainstem Glioma
Status:
COMPLETED
Status Verified Date:
2013-10
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:
This phase II trial is studying how well tipifarnib works in treating young patients with recurrent or progressive high-grade glioma medulloblastoma primitive neuroectodermal tumor or brain stem glioma Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
Detailed Description:
OBJECTIVES
I Determine the response rate in pediatric patients with recurrent or progressive high-grade glioma medulloblastomaprimitive neuroectodermal tumor PNET or brain stem glioma treated with tipifarnib
II Determine the distribution of time to progression time to treatment failure and time to death in patients treated with this drug
OUTLINE This is an open-label multicenter study Patients are stratified according to disease high-grade glioma vs recurrent or progressive medulloblastomaprimitive neuroectodermal tumor PNET vs progressive diffuse intrinsic brain stem glioma
Patients receive oral tipifarnib twice daily on days 1-21 Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity
I Determine the response rate in pediatric patients with recurrent or progressive high-grade glioma medulloblastomaprimitive neuroectodermal tumor PNET or brain stem glioma treated with tipifarnib
II Determine the distribution of time to progression time to treatment failure and time to death in patients treated with this drug
OUTLINE This is an open-label multicenter study Patients are stratified according to disease high-grade glioma vs recurrent or progressive medulloblastomaprimitive neuroectodermal tumor PNET vs progressive diffuse intrinsic brain stem glioma
Patients receive oral tipifarnib twice daily on days 1-21 Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| U10CA098543 | NIH | CTEP | httpsreporternihgovquickSearchU10CA098543 |
| NCI-2012-01806 | REGISTRY | None | None |
| CDR0000334862 | None | None | None |
| COG-ACNS0226 | None | None | None |
| ACNS0226 | OTHER | None | None |
| ACNS0226 | OTHER | None | None |