A Phase II Trial of Multiple Cycles of Sequential High Dose Chemotherapy for Patients With Chemotherapy Sensitive Relapsed Non-Hodgkin's Lymphoma
OBJECTIVES: I. Determine how many patients with chemotherapy sensitive relapsed
non-Hodgkin's lymphoma receiving sequential high dose chemotherapy achieve a collection of a
minimum 5 million CD34+ cells/kg in one large volume apheresis. II. Determine the
feasibility and safety of this regimen in these patients. III. Determine disease free and
overall survival of patients receiving this regimen.
OUTLINE: Patients receive cyclophosphamide IV over 1 hour followed by paclitaxel IV over 24
hours on day 1. Filgrastim (G-CSF) and stem cell factor (SCF) are administered
subcutaneously beginning on day 3 for approximately 7-14 days (until the completion of
leukapheresis). Peripheral blood stem cells (PBSC) are collected over 3-5 days. Three weeks
after leukapheresis is completed, patients receive cytarabine IV over 2 hours twice a day on
days -6 to -3. Mitoxantrone IV is administered over 1 hour on day -6. CD34+ PBSC are
reinfused on day 0. Four weeks later, patients receive etoposide IV over 11 hours on day -2
and melphalan IV over 30 minutes twice on day -1. CD34+ PBSC are reinfused on day 0.
Concurrent G-CSF is administered subcutaneously and continues until blood counts recover.
Patients are followed at 4 weeks, every 3 months for the first 2 years, and then every 6
months for the next 2 years.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
Primary Purpose: Treatment
Russell J. Schilder, MD
Fox Chase Cancer Center
United States: Federal Government
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|