HD-K: Salvage Therapy With High Dose Oral Clarithromycin in Relapsed or Refractory Extranodal Marginal Zone Lymphoma

Sponsor

Andres J. M. Ferreri (Other)

Overall Status

Completed

CT.gov ID

NCT01516606

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: clarithromycin, oral, high dose	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	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 Other Names: klacid

Arm

Intervention/Treatment

Experimental: 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

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

Other Names:

klacid

Outcome Measures

Primary Outcome Measures

assessment of responses [The best clinical response at 6 months from trial registration]
evaluation of activity in terms of global responses, complete responses and duration of responses

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)