Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003739
Status:
COMPLETED
Last Update Posted:
2014-02-14
First Post:
1999-11-01
Brief Title:
Antibiotic Therapy With or Without G-CSF in Treating Children With Neutropenia and Fever Caused by Chemotherapy
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Randomized Comparison Between Antibiotics Alone and Antibiotics Plus Granulocyte-Colony Stimulating Factor in Pediatric Patients With Chemotherapy Induced Febrile Neutropenia
Status:
COMPLETED
Status Verified Date:
2014-02
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:
RATIONALE Antibiotics may decrease the side effects of neutropenia and fever caused by chemotherapy Colony-stimulating factors such as G-CSF 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 It is not yet known whether antibiotic therapy plus G-CSF is more effective than antibiotic therapy alone for treating side effects caused by chemotherapy
PURPOSE Randomized phase III trial to compare the effectiveness of antibiotic therapy with or without G-CSF in treating children who have neutropenia and fever that are caused by chemotherapy
PURPOSE Randomized phase III trial to compare the effectiveness of antibiotic therapy with or without G-CSF in treating children who have neutropenia and fever that are caused by chemotherapy
Detailed Description:
OBJECTIVES
Determine whether filgrastim G-CSF used in addition to standard antibiotic therapy accelerates time to resolution of febrile neutropenia in children receiving chemotherapy
OUTLINE This is a randomized study Patients are randomized to one of two treatment arms
Arm I Patients receive standard antibiotic therapy
Arm II Patients receive treatment as in arm I Patients also receive filgrastim G-CSF subcutaneously or IV once a day until at least 2 consecutive afebrile days have passed and absolute neutrophil count is at least 500mm3
Patients are followed for 3 days
PROJECTED ACCRUAL A total of 200 patients 100 per treatment arm will be accrued for this study
Determine whether filgrastim G-CSF used in addition to standard antibiotic therapy accelerates time to resolution of febrile neutropenia in children receiving chemotherapy
OUTLINE This is a randomized study Patients are randomized to one of two treatment arms
Arm I Patients receive standard antibiotic therapy
Arm II Patients receive treatment as in arm I Patients also receive filgrastim G-CSF subcutaneously or IV once a day until at least 2 consecutive afebrile days have passed and absolute neutrophil count is at least 500mm3
Patients are followed for 3 days
PROJECTED ACCRUAL A total of 200 patients 100 per treatment arm 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 |
|---|---|---|---|
| CDR0000066854 | OTHER | Clinical Trialsgov | None |
| COG-AS973 | OTHER | None | None |
| COG-S9703 | OTHER | None | None |
| CCG-S9703 | OTHER | None | None |
| COG-973 | OTHER | None | None |
| NCI-P99-0140 | None | None | None |