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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Information provided by: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00461084 |
Purpose
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 cells.There is some evidence that this medication may change the behavior of lymphocytes, in addition to its known anti-infection activity.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: BIAXIN (CLARITHROMYCIN) Drug: Biaxin (clarithromycin) |
Phase II |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Biaxin(Clarithromycin)Based Antibiotic Therapy In Previously Untreated, Advanced Stage Indolent Lymphoma |
tissue and whole blood
| Estimated Enrollment: | 74 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | April 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
lymphoma follicular
|
Drug: BIAXIN (CLARITHROMYCIN)
Biaxin (clarithromycin) 500 mg will be administered by mouth twice daily for 12 weeks in all patients. In H. pylori positive patients, Prevpak standard therapy (lansoprazole, amoxicillin, clarithromycin) will be administered for the first 2 weeks.Following Biaxin (clarithromycin) antibiotic therapy, the patient will be reassessed for eradication of H. pylori if previously present.
|
|
2
lymphoma non-follicular
|
Drug: Biaxin (clarithromycin)
Biaxin (clarithromycin) 500 mg will be administered by mouth twice daily for 12 weeks in all patients. In H. pylori positive patients, Prevpak standard therapy (lansoprazole, amoxicillin, clarithromycin) will be administered for the first 2 weeks.Following Biaxin (clarithromycin) antibiotic therapy, the patient will be reassessed for eradication of H. pylori if previously present.
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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 Follicular/Non-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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Previously Untreated follicular lymphoma or non-follicular lymphoma will be recrited at MSKCC
Inclusion Criteria:
Staging fulfills criteria for no initial treatment according to GELF criteria for advanced stage disease. None of the following should be present:
Exclusion Criteria:
GELF criteria21 for institution of systemic chemotherapy, which includes:
Contacts and Locations| Contact: Carol Portlock, MD | 212 639-8109 | portlocc@mskcc.org |
| Contact: Paul Hamlin, MD | 212 639-6143 | hamlinp@mskcc.org |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Carol Portlock, MD | |
| Contact: Paul Hamlin, MD | |
| Principal Investigator: Carol Portlock, MD | |
| Principal Investigator: | Carol Portlock, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | Memorial Sloan Kettering Cancer Center ( Carol Portlock, MD ) |
| Study ID Numbers: | 07-038 |
| Study First Received: | April 13, 2007 |
| Last Updated: | October 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00461084 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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Lymphoma Advanced Stage Untreated Advanced Stage Lymphoma Untreated Lymphoma |
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Anti-Infective Agents Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Enzyme Inhibitors Pharmacologic Actions Lymphatic Diseases |
Anti-Bacterial Agents Clarithromycin Protein Synthesis Inhibitors Neoplasms Therapeutic Uses Lymphoproliferative Disorders Lymphoma |