Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT00504751
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
Study:
NCT00504751
Study Brief:
Protocol Section:
NCT00504751