Phase II Study of "VIPER" Chemotherapy in Rel/Ref DLBCL

Status Completed

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00504751
Study type	Interventional
Source	Weill Medical College of Cornell University
Contact
Status	Completed
Phase	Phase 2
Start date	May 2007
Completion date	February 17, 2012

View Details

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