Breast Cancer Clinical Trial
Official title:
Combination of Interleukin 11 (Neumega) With G-CSF to Mobilize Autologous Peripheral Blood Stem Cells (PBSC)
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.
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.
;
Primary Purpose: Treatment
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