Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023764
Status:
COMPLETED
Last Update Posted:
2015-12-08
First Post:
2001-09-13
Brief Title:
Bortezomib in Treating Patients With Lymphoproliferative Disorders
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of PS-341 in Low Grade Lymphoproliferative Disorders
Status:
COMPLETED
Status Verified Date:
2012-12
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:
Phase II trial to study the effectiveness of bortezomib in treating patients who have low-grade lymphoproliferative disorders Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth
Detailed Description:
PRIMARY OBJECTIVES
I Determine the frequency and duration of complete and partial response rates in patients with grade I II or III follicular lymphoma or mantle cell lymphoma treated with bortezomib
SECONDARY OBJECTIVES
I Determine the response of minimal residual disease by polymerase chain reaction PCR detectable or clonotypic PCR minimal residual disease in bone marrow of patients treated with this regimen
II Determine the time to progression and overall survival of patients treated with this regimen
III Determine the toxic effects of this regimen in these patients
OUTLINE Patients are stratified according to disease type follicular lymphoma vs mantle cell lymphoma
Patients receive an infusion of bortezomib over 3-5 seconds once weekly for 4 weeks Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity Patients who achieve at least a partial response lasting at least 6 months may receive retreatment
Patients are followed every 3 months for 1 year and then every 4 months for 2 years
I Determine the frequency and duration of complete and partial response rates in patients with grade I II or III follicular lymphoma or mantle cell lymphoma treated with bortezomib
SECONDARY OBJECTIVES
I Determine the response of minimal residual disease by polymerase chain reaction PCR detectable or clonotypic PCR minimal residual disease in bone marrow of patients treated with this regimen
II Determine the time to progression and overall survival of patients treated with this regimen
III Determine the toxic effects of this regimen in these patients
OUTLINE Patients are stratified according to disease type follicular lymphoma vs mantle cell lymphoma
Patients receive an infusion of bortezomib over 3-5 seconds once weekly for 4 weeks Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity Patients who achieve at least a partial response lasting at least 6 months may receive retreatment
Patients are followed every 3 months for 1 year and then every 4 months for 2 years
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 |
|---|---|---|---|
| NCI-2012-01406 | REGISTRY | None | None |
| UNMC-03903 | None | None | None |
| MSKCC-01049 | None | None | None |
| NCI-2795 | None | None | None |
| CDR0000068860 | None | None | None |
| CWRU-MSKCC-1Y02 | None | None | None |
| 01-049 | OTHER | None | None |
| 2795 | OTHER | None | None |
| P30CA008748 | NIH | None | None |
| U01CA062502 | NIH | None | None |
| N01CM62206 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62206 |