24
Participants
Start Date
November 30, 2009
Primary Completion Date
December 31, 2015
Study Completion Date
December 31, 2015
Everolimus (RAD001)
Beginning dose of 5 mg tablets every other day by mouth followed by a big glass of water. First dose will occur 1 day before receiving chemotherapy.
Cyclophosphamide
300 mg/m\^2 intravenous (IV) over 3 hours every 12 hours x 6 doses on Days 1, 2, 3 (total dose 1800 mg/m2).
Vincristine
2 mg IV on Day 4 and Day 11 ± 2 days.
Doxorubicin
50 mg/m\^2 IV over 24 hours via central venous catheter on day 4, after last dose of Cyclophosphamide given.
Dexamethasone
40 mg IV or orally daily days 1-4 ± 2 days and days 11-14 ± 2 days.
Mesna
600 mg/m\^2 IV continuous infusion daily for 24 hours days 1-3.
Methotrexate
200 mg/m\^2 IV over 2 hours followed by 800 mg/m\^2 IV over 22 hours day 1.
Ara-C (Cytarabine)
3 gm/m\^2 IV over 2 hours every 12 hours for 4 doses on days 2, 3.
Methylprednisone
50 mg IV over 2 hours approximately every 12 hours for 6 doses days 1-3.
G-CSF
10 mcg/kg/day (rounded) within 72 ± 48 hours after completion of chemotherapy until neutrophil recovery 1 x 109/L or higher. Pegfilgrastim (given at 6 mg subcutaneous for one dose approximately 24 hours after completion of the chemotherapy) may be substituted for G-CSF.
University of Texas MD Anderson Cancer Center, Houston
Collaborators (1)
Novartis
INDUSTRY
M.D. Anderson Cancer Center
OTHER