Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016094
Status:
COMPLETED
Last Update Posted:
2013-01-29
First Post:
2001-05-06
Brief Title:
S0108 Bevacizumab in Treating Patients With Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Bevacizumab rhuMab VEGF NSC-704865 Therapy for Patients With Relapsed Aggressive Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-01
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 bevacizumab in treating patients who have non-Hodgkins lymphoma Monoclonal antibodies such as bevacizumab may stop the growth of cancer by stopping blood flow to the tumor Bevacizumab may be an effective treatment for non-Hodgkins lymphoma
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the 6-month progression-free survival rate in patients with relapsed aggressive NHL treated with single agent bevacizumab therapy
II To evaluate response rate and toxicity in patients with relapsed aggressive NHL treated with this regimen
III To measure tumor VEGF and VEGF receptor 1 and 2 expression Flt-1 and Flk-1KDR and to explore the correlation between expression level and histology and response
IV To measure pre-therapy week 8 and time to progression biologic measures of VEGF activity including plasma VEGF levels urinary VEGF levels and circulating number of endothelial cells and explore the correlation with response
OUTLINE
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 Treatment repeats every 28 days for a maximum of 24 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 3 years
I To estimate the 6-month progression-free survival rate in patients with relapsed aggressive NHL treated with single agent bevacizumab therapy
II To evaluate response rate and toxicity in patients with relapsed aggressive NHL treated with this regimen
III To measure tumor VEGF and VEGF receptor 1 and 2 expression Flt-1 and Flk-1KDR and to explore the correlation between expression level and histology and response
IV To measure pre-therapy week 8 and time to progression biologic measures of VEGF activity including plasma VEGF levels urinary VEGF levels and circulating number of endothelial cells and explore the correlation with response
OUTLINE
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 Treatment repeats every 28 days for a maximum of 24 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 3 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 |
|---|---|---|---|
| S0108 | None | None | None |
| U10CA032102 | NIH | None | None |
| CDR0000068594 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA032102 |