Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004853
Status:
COMPLETED
Last Update Posted:
2019-11-12
First Post:
2000-03-04
Brief Title:
Comparison of Filgrastim and Filgrastim SD01in Boosting White Cell Counts After Intensive Chemotherapy
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Randomized Trial of Filgrastim-SD01 vs Filgrastim in Newly Diagnosed Children and Young Adults With Sarcoma Treated With Dose-Intensive Chemotherapy
Status:
COMPLETED
Status Verified Date:
2016-01-27
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:
Filgrastim granulocyte colony-stimulating factor which is administered by daily subcutaneous injection after cytotoxic chemotherapy shortens the duration of chemotherapy-induced neutropenia and lowers the risk of infection In children treated with dose-intensive chemotherapy filgrastim reduces the duration of severe neutropenia and as a result has become a standard component of the treatment regimen Filgrastim-SD01 AMGEN which is produced by PEGylation of the amino-terminus of filgrastim is a sustained duration form of granulocyte colony-stimulating factor In phase I and phase II trials in adults a single dose of Filgrastim-SD01 appears to be equivalent to daily dosing of filgrastim in enhancing neutrophil recovery and has a comparable adverse event profile
Dose-intensive vincristinecyclophosphamidedoxorubicin VDoxC alternating with ifosfamideetoposide IE has become standard therapy for children and adolescents with Ewings sarcoma and other sarcomas treated at the POBNCI and other cancer centers within the US Supportive care measures used in children who are treated with this regimen include mesna to prevent oxazaphosphorine urotoxicity dexrazoxane to reduce doxorubicin cardiotoxicity and filgrastim to shorten the duration of neutropenia The purpose of this randomized open label trial is to compare the tolerance toxicity and therapeutic effects of Filgrastim-SD01 given as a single injection after chemotherapy to daily subcutaneous filgrastim in patients with newly diagnosed sarcoma The pharmacokinetics of Filgrastim-SD01 will also be compared to the pharmacokinetics of filgrastim This trial will also be a platform for performing biological studies of these tumors and for detailed cardiac studies High-risk patients who are treated on this front line trial and respond will also be candidates for a planned transplant protocol A total of 34 patients 17 patients per treatment arm will be entered onto the trial
Dose-intensive vincristinecyclophosphamidedoxorubicin VDoxC alternating with ifosfamideetoposide IE has become standard therapy for children and adolescents with Ewings sarcoma and other sarcomas treated at the POBNCI and other cancer centers within the US Supportive care measures used in children who are treated with this regimen include mesna to prevent oxazaphosphorine urotoxicity dexrazoxane to reduce doxorubicin cardiotoxicity and filgrastim to shorten the duration of neutropenia The purpose of this randomized open label trial is to compare the tolerance toxicity and therapeutic effects of Filgrastim-SD01 given as a single injection after chemotherapy to daily subcutaneous filgrastim in patients with newly diagnosed sarcoma The pharmacokinetics of Filgrastim-SD01 will also be compared to the pharmacokinetics of filgrastim This trial will also be a platform for performing biological studies of these tumors and for detailed cardiac studies High-risk patients who are treated on this front line trial and respond will also be candidates for a planned transplant protocol A total of 34 patients 17 patients per treatment arm will be entered onto the trial
Detailed Description:
Background
Filgrastim granulocyte colony-stimulating factor which is administered by daily subcutaneous injection after cytotoxic chemotherapy shortens the duration of chemotherapy-induced neutropenia and lowers the risk of infection
In children treated with dose-intensive chemotherapy Filgrastim reduces the duration of severe neutropenia and as a result has become a standard component of the treatment regimen
Filgrastim-SD01 AMGEN which is produced by PEGylation of the amino-terminus of Filgrastim is a sustained duration form of granulocyte colony-stimulating factor
In phase I and phase II trials in adults a single dose of Filgrastim-SD01 appears to be equivalent to daily dosing of Filgrastim in enhancing neutrophil recovery and has a comparable adverse event profile
Dose-intensive vincristinecyclophosphamidedoxorubicin VDoxC alternating with ifosfamideetoposide IE has become standard therapy for children and adolescents with Ewings sarcoma and other sarcomas treated at the POBNCI and other cancer centers within the US
Objectives
Compare the tolerance toxicity and therapeutic effects of Filgrastim-SD01 given as a single injection after chemotherapy to daily subcutaneous Filgrastim in patients with newly diagnosed sarcoma receiving multi-agent dose intensive chemotherapy
The pharmacokinetics of Filgrastim-SD01 will also be compared to the pharmacokinetics of Filgrastim
This trial will also be a platform for performing biological studies of these tumors study neutrophil function and CD34 mobilization and for detailed cardiac studies
Eligibility
Children and young adults less than or equal to 25 years with previously untreated high-risk sarcomas Ewing sarcoma rhabdomyosarcoma MPNST and synovial sarcoma
No evidence of tumor infiltration of the bone marrow
Design
Participants will be randomized 11 to receive a single dose of Filgrastim-SD01 or daily filgrastim as a SQ injection after each cycle of chemotherapy
Standard 5 drug dose-intensive chemotherapy with vincristine doxorubicin cyclophosphamide alternating with ifosfamide and etoposide will be administered
Surgery or radiation for the primary tumor will occur after cycle 5
A total of 34 patients 17 patients per treatment arm will be entered onto the trial
Filgrastim granulocyte colony-stimulating factor which is administered by daily subcutaneous injection after cytotoxic chemotherapy shortens the duration of chemotherapy-induced neutropenia and lowers the risk of infection
In children treated with dose-intensive chemotherapy Filgrastim reduces the duration of severe neutropenia and as a result has become a standard component of the treatment regimen
Filgrastim-SD01 AMGEN which is produced by PEGylation of the amino-terminus of Filgrastim is a sustained duration form of granulocyte colony-stimulating factor
In phase I and phase II trials in adults a single dose of Filgrastim-SD01 appears to be equivalent to daily dosing of Filgrastim in enhancing neutrophil recovery and has a comparable adverse event profile
Dose-intensive vincristinecyclophosphamidedoxorubicin VDoxC alternating with ifosfamideetoposide IE has become standard therapy for children and adolescents with Ewings sarcoma and other sarcomas treated at the POBNCI and other cancer centers within the US
Objectives
Compare the tolerance toxicity and therapeutic effects of Filgrastim-SD01 given as a single injection after chemotherapy to daily subcutaneous Filgrastim in patients with newly diagnosed sarcoma receiving multi-agent dose intensive chemotherapy
The pharmacokinetics of Filgrastim-SD01 will also be compared to the pharmacokinetics of Filgrastim
This trial will also be a platform for performing biological studies of these tumors study neutrophil function and CD34 mobilization and for detailed cardiac studies
Eligibility
Children and young adults less than or equal to 25 years with previously untreated high-risk sarcomas Ewing sarcoma rhabdomyosarcoma MPNST and synovial sarcoma
No evidence of tumor infiltration of the bone marrow
Design
Participants will be randomized 11 to receive a single dose of Filgrastim-SD01 or daily filgrastim as a SQ injection after each cycle of chemotherapy
Standard 5 drug dose-intensive chemotherapy with vincristine doxorubicin cyclophosphamide alternating with ifosfamide and etoposide will be administered
Surgery or radiation for the primary tumor will occur after cycle 5
A total of 34 patients 17 patients per treatment arm will be entered onto the trial
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 |
|---|---|---|---|
| 00-C-0092 | None | None | None |