Clinical trial NCT01516606: Salvage Therapy With High Dose Oral Clarithromycin in Relapsed or Refractory Extranodal Marginal Zone Lymphoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: MALT
refractory
relapsed
extranodal
relapsed or refractory extranodal marginal zone lymphoma
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2012-01-25
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: assessment of responses
timeFrame: The best clinical response at 6 months from trial registration
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Dpt of OncoHematology - Fondazione Centro San Raffaele del Monte Tabor
Study officials:
affiliation: San Raffaele Scientific Institute, Milano, Italy
name: Andrés JM Ferreri, MD
role: STUDY_CHAIR
References:
citation: Ferreri AJ, Sassone M, Kiesewetter B, Govi S, Scarfo L, Donadoni G, Raderer M. High-dose clarithromycin is an active monotherapy for patients with relapsed/refractory extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT): the HD-K phase II trial. Ann Oncol. 2015 Aug;26(8):1760-5. doi: 10.1093/annonc/mdv214. Epub 2015 May 1.