Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003241
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-11-01
Brief Title:
Phenylacetate in Treating Children With Recurrent or Progressive Brain Tumors
Sponsor:
Texas Childrens Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Phenylacetate in Pediatric Patients With Central Nervous System Tumors
Status:
COMPLETED
Status Verified Date:
2000-04
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 phenylacetate in treating children with recurrent or progressive brain tumors
PURPOSE Phase II trial to study the effectiveness of phenylacetate in treating children with recurrent or progressive brain tumors
Detailed Description:
OBJECTIVES I Determine the efficacy of phenylacetate in terms of response rate and time to progression in children with recurrent or progressive brain tumors or with previously untreated poor prognosis brain tumors II Assess the toxicity of phenylacetate in these patients treated at the maximum tolerated dose III Determine the correlation between serum steady state phenylacetate levels and toxicity or response in these patients
OUTLINE Patients are stratified by histologic type anaplastic astrocytoma and glioblastoma multiforme vs brain stem glioma vs medulloblastoma and primitive neuroectodermal tumors vs ependymoma vs low grade glioma vs others Patients receive phenylacetate as a continuous intravenous infusion on days 1-28 Courses of treatment are given continuously without rest Treatment continues in the absence of disease progression or unacceptable toxicity Patients are followed weekly
PROJECTED ACCRUAL A total of 9-30 patients per stratum will be accrued for this study in 2 years
OUTLINE Patients are stratified by histologic type anaplastic astrocytoma and glioblastoma multiforme vs brain stem glioma vs medulloblastoma and primitive neuroectodermal tumors vs ependymoma vs low grade glioma vs others Patients receive phenylacetate as a continuous intravenous infusion on days 1-28 Courses of treatment are given continuously without rest Treatment continues in the absence of disease progression or unacceptable toxicity Patients are followed weekly
PROJECTED ACCRUAL A total of 9-30 patients per stratum will be accrued for this study in 2 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 |
|---|---|---|---|
| NCI-T96-0070 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066116 | REGISTRY | None | None |
| NCI-98-C-0107D | None | None | None |