A Phase II Trial of ICE Chemotherapy Followed by High Dose BEAM Chemotherapy With Autologous Peripheral Blood Progenitor Cell Transplantation in Patients >= 60 Years Old With Refractory or Relapsed Intermediate Grade Non-Hodgkin's Lymphoma
- Assess the efficacy and toxic effects of carmustine/etoposide/melphalan (ICE)
chemotherapy followed by peripheral blood progenitor cell transplantation in patients
with refractory or relapsed intermediate grade non-Hodgkin's lymphoma.
- Assess the ability of the ICE chemotherapy regimen, in conjunction with filgrastim, to
mobilize peripheral blood stem cells.
OUTLINE: This is a descriptive pilot study.
Patients receive 3 cycles of induction chemotherapy with ifosfamide, carboplatin, and
etoposide (ICE). Each cycle is given at least 14 days apart. Patients receive etoposide IV
on days 1 through 3. Carboplatin and ifosfamide with mercaptoethane sulfonate is given IV
over 24 hours on day 2.
During cycles 1 and 2, patients receive filgrastim (G-CSF) SC every 6 hours beginning on day
1 and continuing until the desired absolute neutrophil count (ANC) is attained.
Patients receive at least 24 hours of rest before PBPC infusion on day 0.
Following cycle 3, G-CSF is given SC beginning on day 6 and continuing until completion of
PBPC collection. However, bone marrow will be harvested if an insufficient number of stem
cells are collected after 5 leukaphereses.
Patients with residual disease limited to 2 sites receive radiation therapy twice a day
within 2 weeks prior to high dose BEAM chemotherapy with carmustine, etoposide, cytarabine,
Patients receive carmustine IV on day -7. Etoposide and cytarabine are given IV every 12
hours on days -6 through -3. Melphalan is given IV on day -2.
G-CSF is administered every 12 hours beginning on day 1 and continuing until the desired ANC
is attained. If ANC is attenuated on day 21, patients undergo a repeat bone marrow biopsy
and receive filgrastim SC.
Patients are followed for 2 years posttransplant, then for 3 to 5 years at 4 month intervals
and every 6 months following the fifth posttransplant.
PROJECTED ACCRUAL: This study will accrue 30 patients for the duration of 2 years.
Primary Purpose: Treatment
Craig Moskowitz, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|