Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-30 @ 10:32 AM
Study NCT ID:
NCT00504751
Status:
COMPLETED
Last Update Posted:
2017-04-07
First Post:
2007-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase II Study of "VIPER" Chemotherapy in Rel/Ref DLBCL
Sponsor:
Weill Medical College of Cornell University
Organization:
Study Overview
Official Title:
Phase II Trial of "VIPER" Chemotherapy in Relapsed and Refractory Diffuse Large B-cell Lymphoma (NHL)
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: