A Clinico-Pathological Study to Investigate the Possible Infective Causes of Non-Hodgkin Lymphoma of the Ocular Adnexae (IELSG27)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier:
NCT01010295
First received: August 27, 2009
Last updated: November 22, 2013
Last verified: May 2012
  Purpose

Patients with mucosa-associated lymphoid tissue (MALT) lymphoma of the ocular adnexae (MLOA) will be eligible for treatment with doxycycline (part A: clinico-pathological study); patients with other types of ocular lymphoma, inflammatory lesions or those ineligible/unwilling for treatment with doxycycline can participate in the only pathologic study (part B).


Condition Intervention Phase
Non-Hodgkin Lymphoma
Drug: doxycycline (tetracycline)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinico-pathological Phase II Study With Translational Elements to Investigate the Possible Infective Causes of Non-Hodgkin Lymphoma of the Ocular Adnexae With Particular Reference to Chlamydia Species and the Effects of MALT Lymphoma Treatment With Tetracycline

Resource links provided by NLM:


Further study details as provided by International Extranodal Lymphoma Study Group (IELSG):

Primary Outcome Measures:
  • response rates [ Time Frame: at 6 weeks, 12 weeks, 12 months and 24 months from start of doxycycline ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: September 2006
Study Completion Date: May 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: doxycycline
doxycycline 100 mg twice daily for 3 weeks
Drug: doxycycline (tetracycline)
doxycycline 100 mg twice daily for 3 weeks

Detailed Description:

Patients with suspected lymphoma of the ocular adnexae will undergo a diagnostic biopsy in the usual way. If lymphoma is confirmed the patient will undergo a full staging evaluation and entry into either part A or B of the study will then be considered as follows:

  • clinico-pathological (part A) for patients with MALT lymphoma of the ocular adnexae (MLOA) and eligible for treatment with Doxycycline 100 mg twice daily for 3 weeks ; or
  • pathology only (part B) for patients with other types of ocular lymphoma, inflammatory lesions or those ineligible/unwilling for treatment with doxycycline.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years or over
  2. Histologically confirmed marginal zone B-cell lymphoma of MALT-type
  3. Lymphoma localised to the ocular adnexae (conjunctiva, lacrimal gland, orbit soft tissue, clinical stage IEA) following a CT scan of neck, thorax, abdomen and pelvis, bone marrow aspirate/trephine, full blood count and biochemical profile
  4. No previous treatment, excepting RT for localised lymphoma of the contralateral eye
  5. At least one measurable lesion
  6. No systemic antibiotic therapy in the last three months
  7. No other malignancy in the previous 5 years apart from appropriately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
  8. In women with reproductive potential a willingness to use contraception from entry into the study for a period of 3 months
  9. Written informed consent

Exclusion Criteria:

  1. Pregnant or lactating women
  2. Known allergy to tetracycline
  3. Patients unwilling to comply with the requirements of follow-up as defined by this protocol
  4. Myasthenia gravis (tetracycline can exacerbate muscle weakness)
  5. Systemic lupus erythematous (tetracycline can exacerbate the condition)
  6. Patients with large or rapidly enlarging tumours requiring immediate radiotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010295

Locations
Chile
Hospital del Salvador
Providencia, Santiago, Chile
Italy
Ospedale San Raffaele, Department of Oncology
Milan, Italy, 20132
S. Matteo
Pavia, Italy
A.O. Bianchi-Melacrino-Morelli, Divisione di Ematologia
Reggio Calabria, Italy
Spain
Hospital Ramon y Cajal
Madrid, Spain
Switzerland
IOSI
Bellinzona, Switzerland, 6500
Sponsors and Collaborators
International Extranodal Lymphoma Study Group (IELSG)
Investigators
Study Chair: Andrés JM Ferreri, MD International Extranodal Lymphoma Study Group
  More Information

No publications provided

Responsible Party: International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier: NCT01010295     History of Changes
Other Study ID Numbers: IELSG27, EudraCT number 2006-005795-41
Study First Received: August 27, 2009
Last Updated: November 22, 2013
Health Authority: Switzerland: Swissmedic
Italy: Ethics Committee
Spain: Ethics Committee
Chile: Instituto de Salud Pública de Chile

Keywords provided by International Extranodal Lymphoma Study Group (IELSG):
NHL of the ocular adnexae

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Doxycycline
Tetracycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014