Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00290706
Status:
TERMINATED
Last Update Posted:
2019-05-28
First Post:
2006-02-09
Brief Title:
A Phase III Trial of VELCADE Gemcitabine for Patients With Relapsed or Refractory Aggressive B- and T-cell Non-Hodgkins Lymphoma
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Phase III Trial of Combination Bortezomib VELCADE and Gemcitabine Therapy for Patients With Relapsed or Refractory Aggressive B- and T-cell Non-Hodgkins Lymphoma
Status:
TERMINATED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed per Data Monitoring Committee due to lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as gemcitabine work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Giving gemcitabine together with bortezomib may kill more cancer cells
PURPOSE This phase III trial is studying the side effects and best dose of bortezomib when given together with gemcitabine and to see how well they work in treating patients with relapsed or refractory B-cell or T-cell non-Hodgkins lymphoma
PURPOSE This phase III trial is studying the side effects and best dose of bortezomib when given together with gemcitabine and to see how well they work in treating patients with relapsed or refractory B-cell or T-cell non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the response rate complete and partial remission in patients with relapsed or refractory aggressive B- or T-cell non-Hodgkins lymphoma treated with gemcitabine hydrochloride and bortezomib
Determine the maximum tolerated dose of bortezomib when administered with gemcitabine hydrochloride in these patients
Secondary
Determine the time to treatment failure duration of response and overall survival of patients treated with this regimen
Determine the safety and tolerability of this regimen in these patients
OUTLINE This is a phase I dose-escalation study of bortezomib followed by a phase II open-label study
Phase I Patients receive gemcitabine hydrochloride IV over 30 minutes and bortezomib IV over 3-5 seconds on days 1 and 8 Treatment repeats every 21 days for up to 9 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity DLT OR the dose that at which 2 of 6 patients experience DLT
Phase II Patients receive gemcitabine hydrochloride and bortezomib as in phase I at the MTD
After completion of study therapy patients are followed periodically for 3 years
PROJECTED ACCRUAL A total of 37 patients will be accrued for this study
Primary
Determine the response rate complete and partial remission in patients with relapsed or refractory aggressive B- or T-cell non-Hodgkins lymphoma treated with gemcitabine hydrochloride and bortezomib
Determine the maximum tolerated dose of bortezomib when administered with gemcitabine hydrochloride in these patients
Secondary
Determine the time to treatment failure duration of response and overall survival of patients treated with this regimen
Determine the safety and tolerability of this regimen in these patients
OUTLINE This is a phase I dose-escalation study of bortezomib followed by a phase II open-label study
Phase I Patients receive gemcitabine hydrochloride IV over 30 minutes and bortezomib IV over 3-5 seconds on days 1 and 8 Treatment repeats every 21 days for up to 9 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity DLT OR the dose that at which 2 of 6 patients experience DLT
Phase II Patients receive gemcitabine hydrochloride and bortezomib as in phase I at the MTD
After completion of study therapy patients are followed periodically for 3 years
PROJECTED ACCRUAL A total of 37 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| STU00007425 | OTHER | Northwestern University IRB | None |
| NU 04H4 | OTHER | None | None |
| VEL-03-082 | None | None | None |