Ex Vivo Expanded Megakaryocytes for Supportive Care of Breast Cancer Patients: A Phase I/II Study
- Determine the toxicity of ex vivo expanded megakaryocytes (EVE MK) as a supplement to
peripheral blood stem cell (PBSC) transplantation in patients with breast cancer or
- Compare the effect of this treatment regimen on platelet recovery and platelet function
in these patients vs historical controls.
- Compare the frequency of malignant cells in the EVE MK vs the uncultured PBSC
collection in these patients.
- Determine the optimal time of MK harvest for the production of platelets in vivo.
- Determine the required number of MKs for clinical efficacy in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 durations of CD34+
culture times (6 days vs 9 days).
After an initial harvest of filgrastim (G-CSF)-mobilized autologous peripheral blood stem
cells (PBSC) for transplantation, patients receive one additional dose of G-CSF and undergo
one additional apheresis. The CD34+ cells are cultured in the presence of recombinant human
thrombopoietin, interleukin-3, and flt3 ligand to expand megakaryocytes. Patients then
undergo treatment with high-dose chemotherapy (and, in some cases, total body irradiation)
followed by reinfusion of the conventional PBSC harvest and the ex vivo expanded
Patients are followed until blood counts recover.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Jane N. Winter, MD
Robert H. Lurie Cancer Center
United States: Federal Government
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University||Chicago, Illinois 60611|