CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
bortezomib, dexamethasone, ifosfamide +1 moredrug
Likely dose
bortezomib, dexamethasone, ifosfamide 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00504751
NCT00504751Phase 2Completed
CompareCT.gov

Phase II Trial of "VIPER" Chemotherapy in Relapsed and Refractory Diffuse Large B-cell Lymphoma (NHL)

Weill Medical College of Cornell University·interventional·Posted Jul 20, 2007·Updated Apr 7, 2017

In Brief

A Phase 2 clinical trial evaluating bortezomib, dexamethasone, ifosfamide and mesna, cisplatin, etoposide, rituximab for Non-Hodgkin's Lymphoma. Completed, enrolled 15 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkin's Lymphoma
CountriesUnited States
CollaboratorsMillennium Pharmaceuticals, Inc.

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 20, 2007
Enrollment StartMay 1, 2007
Primary CompletionDec 1, 2010
Study CompletionFeb 17, 2012
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 18.9 years ago

Interventions

bortezomib, dexamethasone, ifosfamidedrug

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

mesna, cisplatin, etoposide, rituximabdrug

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