Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262860
Status:
COMPLETED
Last Update Posted:
2016-05-09
First Post:
2005-12-06
Brief Title:
Bortezomib and Gemcitabine Hydrochloride in Treating Patients With Relapsed or Refractory Hodgkins Lymphoma
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Phase II Pilot Study of Bortezomib VELCADE and Gemcitabine for Patients With Relapsed or Refractory Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2016-03
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:
RATIONALE Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as gemcitabine hydrochloride work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving bortezomib together with gemcitabine hydrochloride may kill more cancer cells
PURPOSE This phase II trial is studying how well giving bortezomib together with gemcitabine hydrochloride works in treating patients with relapsed or refractory Hodgkins lymphoma
PURPOSE This phase II trial is studying how well giving bortezomib together with gemcitabine hydrochloride works in treating patients with relapsed or refractory Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the overall response rate partial and complete response in patients with relapsed or refractory Hodgkins lymphoma treated with bortezomib and gemcitabine hydrochloride
Secondary
Determine the safety and toxic effects of this regimen in these patients
Determine the time to progression in patients treated with this regimen
Correlate NF-kB inhibition and proteasome activity with response in patients treated with this regimen
OUTLINE This is a multicenter pilot study
Patients receive bortezomib IV on days 1 4 8 and 11 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study
Primary
Determine the overall response rate partial and complete response in patients with relapsed or refractory Hodgkins lymphoma treated with bortezomib and gemcitabine hydrochloride
Secondary
Determine the safety and toxic effects of this regimen in these patients
Determine the time to progression in patients treated with this regimen
Correlate NF-kB inhibition and proteasome activity with response in patients treated with this regimen
OUTLINE This is a multicenter pilot study
Patients receive bortezomib IV on days 1 4 8 and 11 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 24 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 |
|---|---|---|---|
| DFCI-04388 | None | None | None |
| URCC-U9404 | None | None | None |
| URCC-RSRB-10368 | None | None | None |
| MILLENNIUM-VEL-03-079 | None | None | None |
| LILLY-B9E-US-X433 | None | None | None |