Spots Global Cancer Trial Database for Phase II Study of "VIPER" Chemotherapy in Rel/Ref DLBCL

Study Description

Brief Summary: Objectives The primary objective of this study is to: • determine the complete and partial response rates and the toxicity profile of bortezomib (VELCADE, formerly PS-341) when administered in combination with DICE chemotherapy plus rituximab (i.e. VIPER) to patients with relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma The secondary objectives of this study are to: * assess event free survival and overall survival * assess conversion of chemo-resistant to chemo-sensitive disease * assess the ability to collect stem cells from patients treated with salvage VIPER who then undergo autologous stem cell transplantation * perform correlative studies on pre-treatment tumor biopsy specimens; analyses will include the assessment of immunohistochemical expression patterns (germinal center B cell vs. activated B cell) and NF-κB activity

Detailed Description: Single arm phase II trial of combination therapy bortezomib, DICE, and Rituximab in patients with relapsed and refractory diffuse large B-cell non-Hodgkin's lymphoma (NHL) VIPER chemotherapy will be administered every 28 days at the following doses: * Dexamethasone 40 mg IV days 1-4 * Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4 * Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide) * Cisplatin 25 mg IV days 1-4 * Etoposide 100 mg/m2 CIVI over 24 hours days 1-4 * Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles) * VELCADE 1.5 mg/m2 on days 2 and 5

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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