Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006263
Status:
WITHDRAWN
Last Update Posted:
2015-08-05
First Post:
2000-09-11
Brief Title:
Carboplatin Temozolomide and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Phase II Trial of Temozolomide Carboplatin and Neupogen in High-Grade Gliomas Both Newly-Diagnosed and Recurrent
Status:
WITHDRAWN
Status Verified Date:
2015-08
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 Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy
PURPOSE Phase II trial to study the effectiveness of combining carboplatin temozolomide and filgrastim in treating patients who have newly diagnosed or recurrent high-grade glioma
PURPOSE Phase II trial to study the effectiveness of combining carboplatin temozolomide and filgrastim in treating patients who have newly diagnosed or recurrent high-grade glioma
Detailed Description:
OBJECTIVES
Determine the response rate in patients with newly diagnosed high-grade glioma treated with temozolomide carboplatin and filgrastim G-CSF
Determine the toxicity of this treatment regimen in these patients
Determine the rate of tumor progression in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to disease category glioblastoma multiforme vs anaplastic astrocytoma vs several other high-grade mixed gliomas
Patients receive carboplatin IV over 4 hours on days 1-2 oral temozolomide every 12 hours on days 1-5 and filgrastim G-CSF subcutaneously or IV daily starting no earlier than day 7 and continuing until blood counts recover Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 102-222 17-37 per each of 6 strata will be accrued for this study within 4 years
Determine the response rate in patients with newly diagnosed high-grade glioma treated with temozolomide carboplatin and filgrastim G-CSF
Determine the toxicity of this treatment regimen in these patients
Determine the rate of tumor progression in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to disease category glioblastoma multiforme vs anaplastic astrocytoma vs several other high-grade mixed gliomas
Patients receive carboplatin IV over 4 hours on days 1-2 oral temozolomide every 12 hours on days 1-5 and filgrastim G-CSF subcutaneously or IV daily starting no earlier than day 7 and continuing until blood counts recover Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 102-222 17-37 per each of 6 strata will be accrued for this study within 4 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NYU-0004H | None | None | None |
| NYU-0029H | None | None | None |
| NCI-G00-1856 | None | None | None |