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

This study is currently recruiting participants.
Verified January 2012 by IRCCS San Raffaele
Sponsor:
Information provided by (Responsible Party):
Andres J. M. Ferreri, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT01516606
First received: January 6, 2012
Last updated: January 19, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention Phase
Lymphoma
 Drug: clarithromycin, oral, high dose
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by IRCCS San Raffaele:

Primary Outcome Measures:
  • assessment of responses [ Time Frame: The best clinical response at 6 months from trial registration ] [ Designated as safety issue: Yes ]
    evaluation of activity in terms of global responses, complete responses and duration of responses


Estimated Enrollment: 19
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: klacid

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516606

Contacts
Contact: Andrés JM Ferreri, MD +30022643 ext 7649 ferreri.andres@hsr.it
Contact: Silvia Govi, MD govi.silvia@hsr.it

Locations
Italy
Dpt of OncoHematology - Fondazione Centro San Raffaele del Monte Tabor Recruiting
Milan, Italy
Contact: Andrés JM Ferreri, MD     +39022643 ext 7649     ferreri.andres@hsr.it    
Principal Investigator: Andrés JM Ferreri, MD            
Sponsors and Collaborators
Andres J. M. Ferreri
Investigators
Study Chair: Andrés JM Ferreri, MD San Raffaele Scientific Institute, Milano, Italy
  More Information

No publications provided

Responsible Party: Andres J. M. Ferreri, MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT01516606     History of Changes
Other Study ID Numbers: HD-K
Study First Received: January 6, 2012
Last Updated: January 19, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by IRCCS San Raffaele:
MALT
refractory
relapsed
extranodal
relapsed or refractory extranodal marginal zone lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
 Lymphoma, Non-Hodgkin
Clarithromycin
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013