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

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ClinicalTrials.gov Identifier: NCT01516606
Recruitment Status : Unknown
Verified January 2012 by Andres J. M. Ferreri, IRCCS San Raffaele.
Recruitment status was:  Recruiting
First Posted : January 25, 2012
Last Update Posted : January 25, 2012
Sponsor:
Information provided by (Responsible Party):
Andres J. M. Ferreri, IRCCS San Raffaele

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 19 participants
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
Study Start Date : January 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

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 Name: klacid



Primary Outcome Measures :
  1. assessment of responses [ Time Frame: The best clinical response at 6 months from trial registration ]
    evaluation of activity in terms of global responses, complete responses and duration of responses



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andres J. M. Ferreri, MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT01516606     History of Changes
Other Study ID Numbers: HD-K
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: January 25, 2012
Last Verified: January 2012

Keywords provided by Andres J. M. Ferreri, 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
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors