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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00005906 |
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 ascites, chylous pleural effusions, chyluria, peripheral lymphedema, and/or lymphangioleiomyomas. Lymphangioleiomyomas are believed to result from a proliferation of abnormal smooth muscle cells within the lymphatic system, which appears to obstruct fluid outflow, leading to fluid accumulation and an increase in size. The lymphangioleiomyomas may occur anywhere along the axial lymphatic chain. In patients with LAM, they occur most frequently in the thorax, abdomen and pelvis and may give rise to a myriad of symptoms (e.g., paresthesias, palpitations, peripheral edema). In some patients, treatment of many of these symptoms, i.e., elevation of lower extremities, paracentesis, thoracentesis, diuretics, and/or surgery, has been ineffective. Previous studies with somatostatin and octreotide in other clinical settings (e.g., traumatic damage to the lymphatics) have shown a successful reduction in chylous effusions, chyluria, ascites, and peripheral lymphedema, when other therapies were less effective. This study will assess the effectiveness of octreotide in symptomatic patients with LAM, lymphangioleiomyomas and/or chylous effusions/ascites, peripheral lymphedema and chyluria.
Condition | Intervention | Phase |
---|---|---|
Lymphangioleiomyomatosis Lymphangiomyomatosis |
Drug: Octreotide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Treatment With Octreotide in Patients With Lymphangioleiomyomatosis |
Estimated Enrollment: | 14 |
Study Start Date: | June 2000 |
Estimated Study Completion Date: | April 2008 |
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 ascites, chylous pleural effusions, chyluria, peripheral lymphedema, and/or lymphangioleiomyomas. Lymphangioleiomyomas are believed to result from a proliferation of abnormal smooth muscle cells within the lymphatic system, which appears to obstruct fluid outflow, leading to fluid accumulation and an increase in size. The lymphangioleiomyomas may occur anywhere along the axial lymphatic chain. In patients with LAM, they occur most frequently in the thorax, abdomen and pelvis and may give rise to a myriad of symptoms (e.g., paresthesias, palpitations, peripheral edema). In some patients, treatment of many of these symptoms, i.e., elevation of lower extremities, paracentesis, thoracentesis, diuretics, and/or surgery, has been ineffective. Previous studies with somatostatin and octreotide in other clinical settings (e.g., traumatic damage to the lymphatics) have shown a successful reduction in chylous effusions, chyluria, ascites, and peripheral lymphedema, when other therapies were less effective. This study will assess the effectiveness of octreotide in symptomatic patients with LAM, lymphangioleiomyomas and/or chylous effusions/ascites, peripheral lymphedema and chyluria.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
All patients enrolled in the Lymphangioleiomyomatosis natural history protocol who have symptoms associated with one of the following may be included: lymphangioleiomyomas, chylous pleural effusion(s), chylous ascites, peripheral lymph-edema, chlopericardium, chyloptysis, protein-losing enteropathy, and/or chyluria. Patients will be included in this protocol if symptoms are attributed to the above processes and the patient believes the severity of symptoms warrants participation in the study. 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, due to effects on hepatic function.
Transplant patients (on cyclosporine).
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 will be excluded because of effects on immune function.
Immunosuppressed patients.
Study ID Numbers: | 000147, 00-H-0147 |
Study First Received: | June 9, 2000 |
Last Updated: | April 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00005906 |
Health Authority: | United States: Federal Government |
Chylous Ascites Chylous Pleural Effusion Inhibitory Effects |
Lymphangioleiomyoma Somatostatin Lymphangioleiomyomatosis (LAM) |
Lymphatic Diseases Pleural Effusion Lymphangioleiomyomatosis Immunoproliferative Disorders Ascites |
Octreotide Lymphangiomyoma Lymphoproliferative Disorders Somatostatin |
Lymphatic Vessel Tumors Neoplasms Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases |
Antineoplastic Agents Therapeutic Uses Gastrointestinal Agents Pharmacologic Actions |