75
Participants
Start Date
October 28, 2004
Primary Completion Date
October 1, 2026
Study Completion Date
October 1, 2026
Etoposide
Etoposide 50 mg/m2 /day continuous intravenous infusion (CIVI) over 24 hours x 4 days (days 1-4) of 21 day cycle. A maximum of 6 cycles of R-EPOCH-R will be administered except in exceptional circumstances.
Interferon-alpha
Ages 18 and over: Initial dose of 7.5 million units subcutaneous, three times weekly x 14 days; subsequent dosesincrease dose as tolerated each 14 days to a maximum of 45 million units subcutaneous three times weekly; Ages 12-17: Initial dose of 5 million units/m2 subcutaneous, three times weekly x 14 days Subsequent doses: Increase dose as tolerated each 14 days to a maximum of 30 million units/m2 subcutaneous, three times weekly
Rituximab
Rituximab 375 mg/m2 IV day 1, shall be administered prior to Doxil injection. When combined with EPOCH chemotherapy, Rituximab will be given on days 1 and 5.
Zidovudine
Cycle 1: Zidovudine 600 mg PO QID x 7-21 days in outpatient setting;600 mg PO q6hours x 7-21 (Intravenous zidovudine 300 mg q 6 hours may be substituted) days for inpatients; Cycle 2 and beyond: 600 mg PO QID x 7 days in outpatient setting; 600 mg PO q 6 hours x 7 days (300 mg q 6 hours may be substituted)
Liposomal Doxorubicin
21 day cycle; 20 mg/m2 Liposomal Doxorubicin given on day 1 and shall be administered after completion of Rituximab infusion from 2 to 6 cycles.
Bortezomib
1.3 mg/m2 IV days 1, 4, 8, and 11. Cycle length is 21 days.
Valganciclovir
Cycle 1: Valganciclovir 900 mg PO BID x 7-21 days in outpatient setting; 900 mg PO q 12 hours x 7-21 days for inpatients; Cycle 2 and beyond: 900 mg PO BID x 7 days for outpatients; 900 mg PO q 12 hours x 7 days (Intravenous ganciclovir 5 mg/kg may be substituted) for inpatients
Doxorubicin
10 mg/m2 /day CIVI over 24 hours x 4 days (days 1-4) of 21 day cycle.
Vincristine
0.4 mg/m2 /day CIVI over 24 hours x 4 days (days 1-4) of 21 day cycle.
Cyclophosphamide
Cyclophosphamide: if CD4 \< 100 cells/mm3, 187 mg/m2 IV (Day 5) if CD4 greater than or equal to 100 cells/mm3, 375 mg/m2 IV (Day 5) of 21 day cycle.
Filgrastim (G-CSF)
Filgrastim 300 micrograms subcutaneous daily beginning day 6 until absolute neutrophil count recovery 5000 cells/mm3 (Pegfilgrastim may be substituted with PI approval, at the recommended dose of one 6mg syringe)
Prednisone
Prednisone 60 mg/m2/day PO x 5 days (days 1-5)of 21 day cycle.
Sirolimus
Maximum daily dose of 40 mg given as a single agent on 21 day cycle.
Observation Only
Observation of symptoms
National Institutes of Health Clinical Center, Bethesda
National Cancer Institute (NCI)
NIH