Phase I/II Study of Escalating Dose Melphalan With Autologous Pluripotent Hematopoietic Stem Cell Support and Amifostine Cytoprotection in Cancer Patients
OBJECTIVES: I. Determine the maximum tolerated dose of high dose melphalan with autologous
peripheral blood stem cell support and amifostine cytoprotection in patients with cancer.
II. Determine the complete response rate, event free survival, overall survival, and
nonrelapse mortality in this patient population.
OUTLINE: This is a dose escalation study of melphalan. Prior to high dose melphalan and
amifostine cytoprotection, patients may receive cyclophosphamide IV. Filgrastim (G-CSF) is
given until cytapheresis is completed. Patients receive high dose melphalan according to an
escalating dose schedule. High dose melphalan is administered IV on day -1. Amifostine is
also administered on days -2 and -1. Peripheral blood stem cell transplantation is performed
on day 0. Dose escalation of high dose melphalan continues until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 8 patients
experience dose limiting toxicity. After the MTD of high dose melphalan is determined,
additional patients are treated at this dose level. Patients are followed at days 30, 100,
365, and yearly thereafter.
PROJECTED ACCRUAL: After the determination of MTD, a total of 14-25 patients will be accrued
for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Donna E. Reece, MD
Lucille P. Markey Cancer Center at University of Kentucky
United States: Food and Drug Administration
|Albert B. Chandler Medical Center, University of Kentucky||Lexington, Kentucky 40536-0084|
|Kimmel Cancer Center of Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|
|Marlene & Stewart Greenebaum Cancer Center, University of Maryland||Baltimore, Maryland 21201|
|Medical College of Wisconsin||Milwaukee, Wisconsin 53226|