Bortezomib, Ifosfamide, Carboplatin, and Etoposide, With or Without Rituximab, in Treating Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin Lymphoma

PHASE1CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

October 31, 2014

Study Completion Date

November 30, 2014

Conditions
Lymphoma
Interventions
BIOLOGICAL

rituximab

375mg/m2 on Day 1

DRUG

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.

DRUG

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."

DRUG

dexamethasone

Part A: 20 mg IV on Days 8-10. Part B: 20 mg IV on Days 1-3 and on Day 8.

DRUG

etoposide

Part A: 100 mg/m2 IV Days 8-10. Part B: 100 mg/m2 IV daily on Days 1 to 3.

DRUG

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."

GENETIC

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.

GENETIC

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.

Trial Locations (17)

10065

Memorial Sloan-Kettering Cancer Center, New York

19106

Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia, Philadelphia

30322

Emory Winship Cancer Institute, Atlanta

33136

University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami

60611

Northwestern Cancer Center, Chicago

77009

Thomas Street Health Center, Houston

95814

University of California at Davis Center for Aids Research and Education Services, Sacramento

96813

Cancer Research Center of Hawaii, Honolulu

98101

Virginia Mason Medical Center, Seattle

92093-0658

Rebecca and John Moores UCSD Cancer Center, La Jolla

90089-9181

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles

90095-1793

UCLA Clinical AIDS Research and Education (CARE) Center, Los Angeles

21231-2410

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

02215

Beth Israel Deaconess Medical Center, Boston

10467-2490

Montefiore Medical Center, The Bronx

43210-1240

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center, Columbus

77030-2707

Baylor College of Medicine, Houston

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

The Emmes Company, LLC

INDUSTRY

lead

AIDS Malignancy Consortium

NETWORK

NCT00598169 - Bortezomib, Ifosfamide, Carboplatin, and Etoposide, With or Without Rituximab, in Treating Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin Lymphoma | Biotech Hunter | Biotech Hunter