Treatment With Octreotide in Patients With Lymphangioleiomyomatosis

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Octreotide

Criteria

• INCLUSION CRITERIA:

Patients enrolled in the lymphangioleiomyomatosis natural history protocol who have symptoms associated with one of the following:

1. lymphangioleiomyomas

2. chylous pleural effusions

3. peripheral lymph-edema

4. chyloptysis

5. protein-losing enteropathy

6. chyluria

Patients will be included in this protocol if symptoms are attributed to the above processes. Patients with malabsorption disorders, diabetes, hypo/hyperthyroidism, or other endocrine-related disorders will be included if justified clinically based on severity of symptoms.

EXCLUSION CRITERIA:

1. Hypersensitivity to somatostatin, octreotide or its analogues

2. Patients with hepatitis B, hepatitis C, or other clinically significant liver diseases

3. Transplant patients

4. Pregnant women or women who are beast-feeding

5. Patient or another responsible party is unable to give the subcutaneous injection

6. Patient unwilling to be followed per the guidelines set forth

7. Patients with decreased renal function (creatinine greater than 1.5)

8. Patients with HIV infection

9. Immunosuppressed patients