Interleukin-11 Plus Filgrastim Prior to Peripheral Stem Cell Transplantation in Patients With Non-Hodgkin's Lymphoma, Hodgkin's Disease, Breast Cancer, or Other Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00004157|
Recruitment Status : Completed
First Posted : February 12, 2004
Last Update Posted : April 2, 2010
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-Hodgkin's lymphoma, Hodgkin's disease, breast cancer, or other solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Gestational Trophoblastic Tumor Kidney Cancer Lymphoma Neuroblastoma Ovarian Cancer Sarcoma Testicular Germ Cell Tumor||Biological: filgrastim Biological: recombinant interleukin-11||Phase 2|
OBJECTIVES: I. Determine the tolerability of interleukin-11 (IL-11) with filgrastim (G-CSF) in patients with non-Hodgkin's lymphoma, Hodgkin's 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Combination of Interleukin 11 (Neumega) With G-CSF to Mobilize Autologous Peripheral Blood Stem Cells (PBSC)|
|Study Start Date :||August 2000|
|Actual Primary Completion Date :||April 2002|
|Actual Study Completion Date :||April 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004157
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109-1024|
|Study Chair:||Leona A. Holmberg, MD, PhD||Fred Hutchinson Cancer Research Center|