A Multi-Center Study of Paclitaxel/Cyclophosphamide and High Dose Melphalan/Etoposide With Autologous Progenitor Cell Transplantation for the Treatment of Inflammatory Breast Cancer
Efforts to cure high-risk breast cancer have increasingly focused on the application of dose
intensive chemotherapy. To date, the use of dose intensive and high-dose chemotherapy has
not significantly changed the survival for the majority of high risk and metastatic
patients. The optimal schedule and combination of agents to improve the results of
high-dose chemotherapy is not known. This study will pilot a combination of chemotherapy
agents for the treatment of Inflammatory Breast Cancer.
To define, in a statistically relevant manner, the clinical efficacy of this chemotherapy
regimen combination in the treatment of Inflammatory Breast Cancer (stage IIIB
To examine the effects of this high-dose chemotherapy on T-cells (T-cell number, phenotype,
cytokine profiles) and study the process of post-chemotherapy T-cell regeneration.
Newly diagnosed patient with non metastatic Inflammatory Breast Cancer (stage III B).
The patients treated in this study will also be eligible for entrance into other protocols
of the experimental Transplantation & Immunology Branch that are examining strategies of
manipulating T-cell regeneration in adults after intensive chemotherapy.
Patients will receive multiple cycles of a dose intensive combination of Paclitaxel and
Cyclophosphamide both for the mobilization of peripheral blood progenitor cells and with
therapeutic intent. A second induction regimen will consist of four cycles of the
combination of Doxorubicin / cyclophosphamide. Patients will subsequently receive high-dose
Melphalan and Etoposide followed by the infusion of peripheral blood progenitor cells and
granulocytes colony-stimulating-factor (G-CSF).
Primary Purpose: Treatment
Ronald E Gress, M.D.
National Cancer Institute (NCI)
United States: Federal Government
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