78
Participants
Start Date
August 31, 2011
Primary Completion Date
September 30, 2015
Study Completion Date
September 30, 2015
Vorinostat
Starting dose: 200 mg by mouth on Days -8 to -2.
Gemcitabine
Starting dose: 2175 mg/m2 by vein on Days -8 and -3. This includes the gemcitabine 75 mg/m2 loading dose.
Busulfan
"AUC: 4,000 micrometer (microM).min/day, or 105 mg/m2/day) on Days -8 to -5.~Pharmacokinetics will be performed with the first dose of 32 mg/m2 by vein on Day -8. The doses on Days -6 and -5 will be subsequently adjusted to target an AUC of 4,000 microMol.min-1. In the event that PK adjusting not possible, a dose of busulfan of 105 mg/m2 will be administered on days -6 and -5."
Melphalan
60 mg/m2 by vein on Days -3 and -2.
Stem Cell Infusion
Infusion of stem cells by vein on Day 0.
Rituximab
375 mg/m2 on days +1 and +8 for patients with CD20+ tumors.
G-CSF
5 mcg/kg/day (rounded up the nearest vial) subcutaneously beginning on Day +5 and continuing until neutrophil recovery is documented.
Palifermin
60 mcg/kg by vein daily for 6 doses. Three doses administrated prior to start chemo (24 hours must elapse between the last dose and first therapeutic dose of chemo) and three doses after the last chemo starting on day 0.
Dexamethasone acetate
8 mg by vein twice a day from day -8 AM to day -2 PM.
University of Texas MD Anderson Cancer Center, Houston
M.D. Anderson Cancer Center
OTHER