Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004157
Status:
COMPLETED
Last Update Posted:
2010-04-02
First Post:
1999-12-10
Brief Title:
Interleukin-11 Plus Filgrastim Prior to Peripheral Stem Cell Transplantation in Patients With Non-Hodgkins Lymphoma Hodgkins Disease Breast Cancer or Other Solid Tumors
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Combination of Interleukin 11 Neumega With G-CSF to Mobilize Autologous Peripheral Blood Stem Cells PBSC
Status:
COMPLETED
Status Verified Date:
2010-03
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 Interleukin-11 and filgrastim stimulate the production of blood cells Giving these drugs to stimulate peripheral stem cells that can be collected for peripheral stem cell transplantation may result in fewer side effects after transplant
PURPOSE Phase II trial to study the effectiveness of interleukin-11 plus filgrastim prior to peripheral stem cell transplantation in patients who have non-Hodgkins lymphoma Hodgkins disease breast cancer or other solid tumors
PURPOSE Phase II trial to study the effectiveness of interleukin-11 plus filgrastim prior to peripheral stem cell transplantation in patients who have non-Hodgkins lymphoma Hodgkins disease breast cancer or other solid tumors
Detailed Description:
OBJECTIVES I Determine the tolerability of interleukin-11 IL-11 with filgrastim G-CSF in patients with non-Hodgkins lymphoma Hodgkins disease breast cancer or other solid tumors II Evaluate the ability to collect CD34 cells and the number of apheresis collections required to reach the target number of CD34 cells in this patient population III Evaluate the time to recovery of platelets and neutrophils and the number of platelet and red blood cell transfusions required following IL-11 and G-CSF mobilized peripheral blood stem cell infusion in these patients
OUTLINE Patients receive interleukin-11 IL-11 subcutaneously SQ on days 1-10 and filgrastim G-CSF SQ on days 4-10 Patients undergo peripheral blood stem cell PBSC collection on days 7-10 until the target number of cells is achieved or for a maximum of 4 collections Patients are followed until transplantation
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 2 years
OUTLINE Patients receive interleukin-11 IL-11 subcutaneously SQ on days 1-10 and filgrastim G-CSF SQ on days 4-10 Patients undergo peripheral blood stem cell PBSC collection on days 7-10 until the target number of cells is achieved or for a maximum of 4 collections Patients are followed until transplantation
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 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 |
|---|---|---|---|
| CDR0000067395 | REGISTRY | PDQ | None |
| FHCRC-136500 | None | None | None |
| NCI-G99-1622 | None | None | None |