Salvage Therapy With High Dose Oral Clarithromycin in Relapsed or Refractory Extranodal Marginal Zone Lymphoma

Study Overview
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Brief Summary
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This is a prospective, phase II study on the activity and tolerability of high dose (2 g/day) oral clarithromycin for the treatment of relapsed or refractory extranodal marginal zone lymphoma.

Detailed Description
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A 6-month regimen of oral clarithromycin has been associated with a 35% ORR in patients with relapsed/refractory marginal zone B-cell lymphoma. Responses were more common among patients with conjunctival lymphoma. This could be explained at least in part by the elimination of clarithromycin by tears, suggesting that a higher tumor bioavailability of this antibiotic could result in a higher activity. Thus, a higher dose of clarithromycin could be associated with a higher tumor bioavailability in tissues other than the conjunctiva.

Official Title
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Phase II Clinical Trial on the Activity of Salvage Therapy With High Dose Oral Clarithromycin in Patients With Relapsed or Refractory Extranodal Marginal Zone Lymphoma

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: clarithromycin, oral, high dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically confirmed diagnosis of extranodal extra-gastric marginal zone cell B lymphoma or gastric Helicobacter pylori positive lymphoma refractory to conventional antibiotic therapy, or H. pylori negative at least one measurable lesion relapsed or refractory lymphoma after systemic (chemotherapy, immunotherapy, antibiotic) or local (surgery or radiation) therapy ECOG PS </= 3 no prior antibiotic therapy within 3 months before enrollment Exclusion Criteria: HIV 1-2 infection concomitant conventional or experimental antitumor therapy (chemotherapy, radiotherapy, immunotherapy, corticosteroids) severe inadequate liver (AST </=3 ULN, ALT </= 3 ULN, bilirubin </=3 ULN) or renal (creatinine </= 1.5 ULN) function allergy to macrolides concomitant malignant neoplasms within prior 5 years (with the exclusion of basal cell carcinoma, in situ spinocellular carcinoma of skin and cervix)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: clarithromycin, oral, high dose<br>2 g/day clarithromycin (once a day) for 14 days followed by 7 days interval to be repeated for 4 cycles in total | Drug: clarithromycin, oral, high dose<br>* 2 g/day clarithromycin (once a day) for 14 days followed by 7 days interval to be repeated for 4 cycles in total<br>* Other names: klacid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of responses | evaluation of activity in terms of global responses, complete responses and duration of responses | The best clinical response at 6 months from trial registration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MALT, refractory, relapsed, extranodal, relapsed or refractory extranodal marginal zone lymphoma