60
Participants
Start Date
September 19, 2002
Primary Completion Date
May 1, 2009
Study Completion Date
December 14, 2011
F-18 Fluorodeoxyglucose
therapeutic allogeneic lymphocytes
Lymphocyte cells are collected from a healthy donor by apheresis and infused into the patient with a central venous catheter.
cyclophosphamide
"Induction - 750 mg/m\^2 intravenous (IV) infusion over 30 minutes x 1 dose. Day 5.~Transplant - 1200 mg/m\^2 per day IV infusion over 2 hours daily for 4 days; days -6, -5, -4, -3."
cyclosporine
6 mg/kg per dose orally every other day (no day 9 dose).
doxorubicin hydrochloride
Induction - 10 mg/m\^2 per day continuous intravenous (IV) infusion over 24 hours daily for 4 days. Days 1, 2, 3, 4.
etoposide
50 mg/m\^2 per day continuous intravenous (IV) infusion over 24 hours daily for 4 days. Days 1, 2, 3, 4.
fludarabine phosphate
"Induction - 25 mg/m\^2 per day intravenous (IV) infusion over 30 minutes daily for 3 days. Days 1, 2, 3.~Transplant - 30 mg/m\^2 per day IV infusion over 30 minutes daily for 4 days; days -6, -5, -4, -3."
melphalan
Transplant - 100 mg/m\^2 per day intravenous (IV) infusion over 15 minutes for 1 day; day -2.
prednisone
Induction - 60 mg/m\^2 per day in 2-4 divided doses by mouth daily for 5 days; days 1, 2, 3, 4, 5.
sirolimus
Initiated on day +3. Patients \>40kg, the initial dose will be 2 mg every 24 hours orally. Patients \<40 kg, the initial dose will be 1 mg/m\^2.
tacrolimus
Day -1 at least 24 hours before the stem cell infusion at a dose of 0.03 mg/kg/day as a continuous infusion. Twelve hours later oral dose initiated at a dose of 0.1-0.15 mg/kg/day in two divided doses every 12 hours.
vincristine sulfate
Induction - 0.4 mg/m\^2 per day continuous intravenous (IV) infusion over 24 hours daily for 4 days; 1, 2, 3, 4.
peripheral blood stem cell transplantation
Stem cells from a healthy donor are collected and transplanted into the patient using a central venous catheter.
Filgrastim
Peripheral Blood Stem Cell donation
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda
National Cancer Institute (NCI)
NIH