Treatment With Octreotide in Patients With Lymphangioleiomyomatosis (NCT00005906) | Clinical Trial Compass
CompletedPhase 2
Treatment With Octreotide in Patients With Lymphangioleiomyomatosis
United States4 participantsStarted 2000-06
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. lymphangioleiomyomas
✓. chylous pleural effusions
✓. peripheral lymph-edema
✓. chyloptysis
✓. protein-losing enteropathy
✓. chyluria
Exclusion criteria
✕. 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
What they're measuring
1
Number of Participants With a Reduction in Total Tumor Volume of at Least 20%.
Timeframe: Six months
2
Number of Participants With a Reduction of Pain/Symptoms as Measured by a Simple Numeric Symptom Distress Scale (NDS) to Rate the Severity of Individual Symptoms.
Timeframe: Six months
Trial details
NCT IDNCT00005906
SponsorNational Heart, Lung, and Blood Institute (NHLBI)