Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005906
Status:
COMPLETED
Last Update Posted:
2010-04-30
First Post:
2000-06-09
Brief Title:
Treatment With Octreotide in Patients With Lymphangioleiomyomatosis
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Treatment With Octreotide in Patients With Lymphangioleiomyomatosis
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lymphangioleiomyomatosis LAM a disease primarily of women of child-bearing age is characterized by cystic lung disease and abdominal tumors eg 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 andor chylous effusionsascites peripheral lymphedema and chyluria
Detailed Description:
Lymphangioleiomyomatosis LAM a disease primarily of women of child-bearing age is characterized by cystic lung disease and abdominal tumors eg angiomyolipomas Within the LAM patient population is a subset of patients who develop chylous ascites chylous pleural effusions chyluria peripheral lymphedema andor 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 eg paresthesias palpitations peripheral edema In some patients treatment of many of these symptoms ie elevation of lower extremities paracentesis thoracentesis diuretics andor surgery has been ineffective Previous studies with somatostatin and octreotide in other clinical settings eg 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 andor chylous effusionsascites peripheral lymphedema and chyluria The dose of octreotide starts at 50 micrograms ug by the subcutaneous route twice a day After two weeks the dose will be increased to 200 ug per day and two weeks later to 400 ugday Maximal dose is 400 ug twice a day
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-H-0147 | OTHER | NHLBI | None |