22
Participants
Start Date
April 30, 2004
Primary Completion Date
July 31, 2015
Study Completion Date
July 31, 2015
Rituximab
Rituximab 375 mg/m2 IV, Days 1 of all cycles
Cyclophosphamide
Cyclophosphamide 800 mg/m2 IV, Day 1, Cyclophosphamide 200 mg/m2 IV Days 2 - 5, Cycles 1 and 3. Cyclophosphamide will be given in 100 cc NS IV over 30 minutes.
Cytarabine
Cytarabine 2 grams/m2 IV every 12 hours x 4 doses, Days 1 and 2, Cycles 2 and 4.
Doxorubicin
Doxorubicin 45 mg/m2 IV bolus, Day 1, Cycles 1 and 3
Etoposide
Etoposide 60 mg/m2 IV daily x 5 days, Cycles 2 and 4
Ifosfamide
Ifosfamide 1.5 grams/m2 IV once a day (QD) x 5 days, Cycles 2 and 4
Leucovorin
Leucovorin 180 mg/m2 IV beginning 36 hours after start of methotrexate infusion and then 12 mg/m2 IV every 6 hours until methotrexate level is below 0.01 nM. Day 10, Cycles 1 and 3.
Methotrexate
Methotrexate 1,200 mg/m2 in 250 cc 5 percent dextrose in water (D5W) IV over 1 hour followed by Methotrexate 5,520 mg/m2 in 1,000 cc D5W by continuous infusion over 23 hours (240 mg/m2 every hour for 23 hours). Day 10, Cycles 1 and 3.
Thalidomide
Maintenance therapy.
Vincristine
Vincristine 1.5 mg/m2 IVP (maximum of 2 mg), Day 1 and 8 , Cycles 1 and 3.
Mesna
Mesna 360 mg/m2 IV every 3 hours x 5 days, Cycles 2 and 4
Filgrastim (G-CSF)
G-CSF 480 mcg subcutaneous (SQ) starting Day 13 (Cycles 1 and 3), Day 7 (Cycles 2 and 4)
Granisetron
Granisetron 1 mg IV on Day 1, Cycle 1 and 3
Decadron
Decadron 10 mg IV on Day 1, Cycles 1 and 3
University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami
University of Miami
OTHER