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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01010295
Other study ID # IELSG27
Secondary ID EudraCT number 2
Status Completed
Phase Phase 2
First received August 27, 2009
Last updated November 22, 2013
Start date September 2006
Est. completion date May 2012

Study information

Verified date May 2012
Source International Extranodal Lymphoma Study Group (IELSG)
Contact n/a
Is FDA regulated No
Health authority Switzerland: SwissmedicItaly: Ethics CommitteeSpain: Ethics CommitteeChile: Instituto de Salud Pública de Chile
Study type Interventional

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date May 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
doxycycline (tetracycline)
doxycycline 100 mg twice daily for 3 weeks

Locations

Country Name City State
Chile Hospital del Salvador Providencia, Santiago
Italy Ospedale San Raffaele, Department of Oncology Milan
Italy S. Matteo Pavia
Italy A.O. Bianchi-Melacrino-Morelli, Divisione di Ematologia Reggio Calabria
Spain Hospital Ramon y Cajal Madrid
Switzerland IOSI Bellinzona

Sponsors (1)

Lead Sponsor Collaborator
International Extranodal Lymphoma Study Group (IELSG)

Countries where clinical trial is conducted

Chile,  Italy,  Spain,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary response rates at 6 weeks, 12 weeks, 12 months and 24 months from start of doxycycline No
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