Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-26 @ 6:47 PM
Study NCT ID:
NCT00016094
Status:
COMPLETED
Last Update Posted:
2013-01-29
First Post:
2001-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S0108 Bevacizumab in Treating Patients With Non-Hodgkin's Lymphoma
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Bevacizumab (rhuMab VEGF) (NSC-704865) Therapy for Patients With Relapsed Aggressive Non-Hodgkin's 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-Hodgkin's 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-Hodgkin's 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-1/KDR) 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-1/KDR) 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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| S0108 | None | None | View | |
| U10CA032102 | NIH | None | https://reporter.nih.gov/quic… | View |
| CDR0000068594 | REGISTRY | PDQ (Physician Data Query) | View |