23
Participants
Start Date
November 30, 2007
Primary Completion Date
October 31, 2014
Study Completion Date
November 30, 2014
rituximab
375mg/m2 on Day 1
bortezomib
Part A: Velcade Day 1 and Day 8 of a 28-day cycle, with inter-subject dose escalation over four dose levels: 0.7 mg/m2, 1 mg/m2, 1.3 mg/m2 and 1.5 mg/m2 Part B: Velcade on Days 1 and 8 of a 21-day cycle.
carboplatin
"Carboplatin will be dosed to an AUC=5, calculated using the Calvert formula (5 x \[creatinine clearance + 25\]; the maximum dose of carboplatin is 750 mg.~Part A: AUC=5 (maximum 750 mg) IV administered on Day 9. Part B: AUC=5 (maximum 750 mg) IV administered on Day 2."
dexamethasone
Part A: 20 mg IV on Days 8-10. Part B: 20 mg IV on Days 1-3 and on Day 8.
etoposide
Part A: 100 mg/m2 IV Days 8-10. Part B: 100 mg/m2 IV daily on Days 1 to 3.
ifosfamide
"Part A: 5000 mg/m2 mixed with an equal amount of Mesna as a 24 hour continuous IV infusion on Day 9.~Part B: 5000 mg/m2 mixed with an equal dose of Mesna administered via continuous infusion for 24 hours beginning on Day 2."
polymerase chain reaction
Correlate EBV/HHV-8 viral load changes with lymphoma response. HIV and EBV/HHV-8 viral loads will be assessed on baseline, day 2, 4, and 8 of week 1 of Part A.
western blotting
Peripheral blood mononuclear cells will be collected at Day 1 prior to chemotherapy, Day 2, 4 and 8 (prior to chemotherapy) then weekly during Part A, just prior to each additional cycle of Part B and at treatment completion. Western blot using antibody specific for APOBEC3G and antibody against actin for internal control will be used to quantify APOBEC3G levels. Changes at will be compared with baseline using a paired t-test.
Memorial Sloan-Kettering Cancer Center, New York
Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia, Philadelphia
Emory Winship Cancer Institute, Atlanta
University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami
Northwestern Cancer Center, Chicago
Thomas Street Health Center, Houston
University of California at Davis Center for Aids Research and Education Services, Sacramento
Cancer Research Center of Hawaii, Honolulu
Virginia Mason Medical Center, Seattle
Rebecca and John Moores UCSD Cancer Center, La Jolla
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles
UCLA Clinical AIDS Research and Education (CARE) Center, Los Angeles
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore
Beth Israel Deaconess Medical Center, Boston
Montefiore Medical Center, The Bronx
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center, Columbus
Baylor College of Medicine, Houston
National Cancer Institute (NCI)
NIH
The Emmes Company, LLC
INDUSTRY
AIDS Malignancy Consortium
NETWORK