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

Andres J. M. Ferreri23 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoma

Interventions

clarithromycin, oral, high doseDRUG

2 g/day clarithromycin (once a day) for 14 days followed by 7 days interval to be repeated for 4 cycles in total

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Dpt of OncoHematology - Fondazione Centro San Raffaele del Monte Tabor

Milan, Italy

Outcomes

Primary Outcomes

assessment of responses

evaluation of activity in terms of global responses, complete responses and duration of responses

Time frame: The best clinical response at 6 months from trial registration

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.