Lymphangioleiomyomatosis Clinical Trial
— TRAILOfficial title:
Trial of Letrozole in Lymphangioleiomyomatosis
NCT number | NCT01353209 |
Other study ID # | 5708 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | May 2011 |
Est. completion date | September 2014 |
Verified date | April 2024 |
Source | University of Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The hypothesis in this study is that estrogen suppression by an aromatase inhibitor in postmenopausal women with lymphangioleiomyomatosis (LAM) will prevent or delay progression of lung disease and result in a decrease in the rate of decline in FEV1
Status | Completed |
Enrollment | 17 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Definite diagnosis of based on compatible chest CT and at least one of the following: 1. biopsy or cytology consistent with LAM, or 2. tuberous sclerosis, renal angiomyolipoma, cystic abdominal lymphangiomas, or chylous effusion in the chest or abdomen, or 3. serum VEGF-D = 800 pg/uL. - post bronchodilator FEV1 =80% predicted or DLCO =70% predicted or RV=120% predicted - female and postmenopausal status as defined by one of the following: 1. prior bilateral oophorectomy or bilateral ovarian irradiation, or 2. age greater than 55 years, and no menstrual period for 12 months or longer. 3. age 18-55 years and estradiol level in the postmenopausal range in the absence of current use of progestational agents. - If still premenopausal, may enter if rendered medically postmenopausal on clinical grounds with the use of gonadotropin releasing hormone (e.g. leuprolide), as long as serum estradiol, FSH, and LH are in the postmenopausal range - Patients with osteopenia or osteoporosis must be receiving appropriate treatment for their osteoporosis or osteopenia at entry into this study. Exclusion Criteria: - Known allergy to letrozole - Inability to comply with pulmonary function tests or follow up visits. - Treatment with investigational agents within 30 days - Hormonal therapy (e.g. estrogen, progestin, LHRH agonists or antagonists, estrogen receptor blockers, estrogen receptor down regulators, aromatase inhibitors) within 30 days month of registration - Medical or psychiatric conditions that would interfere with the ability to provide informed consent. - abnormal hematologic and hepatic function as defined by the following at the time of randomization.: - Neutrophils < 1500/mm3 and platelets < 100,000/mm3 - Bilirubin < 1.25 X upper limit of normal - SGPT (ALT) or SGOT (AST) >2.5 X upper limit of normal |
Country | Name | City | State |
---|---|---|---|
United States | Emory University School of Medicine | Atlanta | Georgia |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Mayo Clinic | Jacksonville | Florida |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | University of Miami | Miami | Florida |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Minor and James | Seattle | Washington |
United States | Stanford University Medical Center | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
University of Cincinnati | United States Department of Defense |
United States,
Lu C, Lee HS, Pappas GP, Dilling DF, Burger CD, Shifren A, Veeraraghavan S, Chapman JT, Parambil J, Ruoss SJ, Young LR, Hammes SR, Kopras EJ, Roads T, Krischer JP, McCormack FX; Trial of an Aromatase Inhibitor in Lymphangioleiomyomatosis Group. A Phase II — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of Change in Forced Expiratory Volume in 1 Second in ml/Month | FEV1 values reported are in liters or milliliters. There are no definite minimum and maximum values of FEV1 as it is a physiological measure of lung function and varies from individual to individual. Higher FEV1 scores indicate better lung function. | 12 months | |
Secondary | Post-bronchodilator FVC | Post-bronchodilator FVC in milliliters | twelve months | |
Secondary | St George Respiratory Questionnaire | Quality of Life scale for respiratory symptoms. This is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating worse quality of life. | twelve months | |
Secondary | Serum VEGF-D | VEGF-D values represent serum VEGF-D levels in pg/ml. Higher levels of VEGF-D are associated with Lymphangioleiomyomatosis. A serum VEGF-D greater than 400 pg/ml is a diagnostic biomarker for LAM. | twelve months |
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