Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00461084
Status:
COMPLETED
Last Update Posted:
2014-09-18
First Post:
2007-04-13
Brief Title:
Biaxin Based Antibiotic Therapy in Previously Untreated Advanced Stage Indolent Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
BiaxinClarithromycinBased Antibiotic Therapy In Previously Untreated Advanced Stage Indolent Lymphoma
Status:
COMPLETED
Status Verified Date:
2014-09
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:
The purpose of this study is to see if a treatment with Biaxin clarithromycin which is an antibiotic given by mouth for 3 months can delay the growth of your lymphoma or shrink the lymphoma We would also like to see how Biaxin clarithromycin works on lymphoma and blood cellsThere is some evidence that this medication may change the behavior of lymphocytes in addition to its known anti-infection activity
Detailed Description:
The primary objective of this study is to evaluate a biaxin clarithromycin-based antibiotic therapy in previously untreated patients with indolent lymphoma who do not require active lymphoma therapy utilizing GELF criteria This is the primary objective Response rate CR PR stratified for FollicularNon-Follicular disease
The secondary objectives of this study are to understand the biologic correlates of indolent lymphoma biaxin clarithromycin response and progression
Response rate CR PR according to H pylori positive or negative RR with a confidence interval will be estimated for each subset Immunohistochemistry in all diagnostic biopsy specimens Lymphocyte- Activated Macrophage CD68 and other selected markers to clarify tumor infiltrating cells Peripheral blood mononuclear cell PBMCs studies to evaluate possible HDAC histone deacetylase inhibition with biaxin clarithromycin therapy
The secondary objectives of this study are to understand the biologic correlates of indolent lymphoma biaxin clarithromycin response and progression
Response rate CR PR according to H pylori positive or negative RR with a confidence interval will be estimated for each subset Immunohistochemistry in all diagnostic biopsy specimens Lymphocyte- Activated Macrophage CD68 and other selected markers to clarify tumor infiltrating cells Peripheral blood mononuclear cell PBMCs studies to evaluate possible HDAC histone deacetylase inhibition with biaxin clarithromycin therapy
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