High-Dose Consolidation With Escalating Doses of Melphalan and Thiotepa for Stage IV Breast Cancer
OBJECTIVES: I. Determine the maximum tolerated dose of melphalan and thiopeta in patients
with recurrent or refractory solid tumors. II. Evaluate the overall survival and response
rate in these patients.
OUTLINE: This is a dose escalation study. Patients receive cyclophosphamide IV over 1 hour
on day 1 and paclitaxel IV over 4 or 24 hours on day 2, followed by daily filgrastim (G-CSF)
subcutaneously beginning on day 3 and continuing through day 7 or until WBCs are greater
than 100,000 cells/mm3. Peripheral blood stem cells (PBSC) or autologous bone marrow is
collected on days 5-7. At 30-50 days following mobilization, patients receive melphalan IV
over 15-60 minutes on days -5 and -4 and thiotepa IV over 2 hours on days -3 and -2,
followed by autologous bone marrow transplantation or PBSC infusion on day 0. Sequential
dose escalation of melphalan is followed by sequential dose escalation of thiotepa. Dose
escalation in cohorts of 5 patients each continues until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose preceding that at which 2 of 4, 3 of 7, 4 of 11,
or 5 of 15 patients experience dose limiting toxicity. Patients are followed at 60 days and
at 12 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.
Primary Purpose: Treatment
William I. Bensinger, MD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|