Treatment With Octreotide in Patients With Lymphangioleiomyomatosis
Lymphangioleiomyomatosis, Lymphangiomyomas, Pleural Effusions
About this trial
This is an interventional treatment trial for Lymphangioleiomyomatosis focused on measuring Chylous Ascites, Chylous Pleural Effusion, Inhibitory Effects, Lymphangioleiomyoma, Somatostatin, Lymphangioleiomyomatosis (LAM)
Eligibility Criteria
INCLUSION CRITERIA: Patients enrolled in the lymphangioleiomyomatosis natural history protocol who have symptoms associated with one of the following: lymphangioleiomyomas chylous pleural effusions peripheral lymph-edema chyloptysis protein-losing enteropathy 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: 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
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Arms of the Study
Arm 1
Experimental
Octreotide
Patients with lymphangioleiomyomatosis and lymphatic tumors, ascites or pleural effusions who are symptomatic will receive subcutaneous injections of octreotide starting at a dose of 100 micrograms per day. Doses will be gradually increased to a maximum of 800 micrograms per day, two months after enrollment, if there is no response to lower doses.