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

Lymphoma Clinical Trial

— HD-K  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516606
• Other study ID #: HD-K
• Status: Completed
• Phase: Phase 2
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: August 2022
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell, Marginal Zone

Intervention

Drug:
• clarithromycin, oral, high dose
2 g/day clarithromycin (once a day) for 14 days followed by 7 days interval to be repeated for 4 cycles in total

Locations

Country	Name	City	State
Italy	Dpt of OncoHematology - Fondazione Centro San Raffaele del Monte Tabor	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Andres J. M. Ferreri

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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