Safety and Efficacy Pilot Trial of the Anti-Viral and Anti-Tumor Activity of Velcade Combined With (R)ICE in Subjects With EBV and/or HHV-8 Positive Relapsed/Refractory AIDS-Associated Non-Hodgkin's Lymphoma

NCT00598169 Phase 1 COMPLETED

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, ifosfamide, carboplatin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving bortezomib together with combination chemotherapy is more effective with or without rituximab in treating AIDS-related non-Hodgkin lymphoma. PURPOSE: This clinical trial is studying giving bortezomib together with dexamethasone, ifosfamide, carboplatin, and etoposide to see how well it works with or without rituximab in treating patients with relapsed or refractory AIDS-related non-Hodgkin lymphoma.

Details

Lead sponsor	AIDS Malignancy Consortium
Phase	Phase 1
Status	COMPLETED
Enrolment	23
Start date	2007-11
Completion	2014-11

Conditions

• Lymphoma

Interventions

• rituximab
• bortezomib
• carboplatin
• dexamethasone
• etoposide
• ifosfamide
• polymerase chain reaction
• western blotting

Primary outcomes

• Maximum tolerated dose of bortezomib — Assessed at end of cycle 1 for each group of 3 subjects
• Overall lymphoma response rate — End of treatment
• Safety as assessed using the CTCAE — Every cycle of treatment and all post-treatment visits

Countries

United States