Treatment With Octreotide in Patients With Lymphangioleiomyomatosis

Completed · Phase 2

Conditions studied: Lymphangioleiomyomatosis, Lymphangiomyomas, Pleural Effusions, Ascites

In brief

Lymphangioleiomyomatosis (LAM), a disease primarily of women of child-bearing age, is characterized by cystic lung disease and abdominal tumors (e.g., angiomyolipomas). Within the LAM patient population is a subset of patients who develop chylous effusions and lymphangioleiomyomas. Treatment of many of these symptoms has been ineffective. Previous studies with somatostatin and octreotide in other clinical settings have shown reduction in chylous effusions. This study assesses the effectiveness of octreotide in symptomatic patients with LAM, lymphangioleiomyomas and/or chylous effusions/ascites, peripheral lymphedema and chyluria.

Key facts

Study ID

NCT00005906

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

4

Starts

2000-06-01

Last updated by the study team

2010-04-30

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• Hypersensitivity to somatostatin, octreotide or its analogues
• Patients with hepatitis B, hepatitis C, or other clinically significant liver diseases
• Transplant patients
• Pregnant women or women who are beast-feeding
• Patient or another responsible party is unable to give the subcutaneous injection
• Patient unwilling to be followed per the guidelines set forth
• Patients with decreased renal function (creatinine greater than 1.5)
• Patients with HIV infection
• Immunosuppressed patients

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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