Trial of Aromatase Inhibition in Lymphangioleiomyomatosis

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

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

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: United States Department of Defense
• Treatments: Letrozole

Criteria

Inclusion Criteria:

• All patients at least must have a diagnosis of pulmonary lymphangioleiomyomatosis as defined by one of the following:

• CT chest compatible with LAM and a biopsy or cytology consistent withLAM.

• CT chest consistent with LAM in the setting of tuberous sclerosis, renal angiomyolipomata, cystic abdominal lymphangiomas, or chylous effusion in the chest or abdomen , or serum VEGF-D > 800 pg/uL.

• All patients must have a post bronchodilator FEV1 ≤80% predicted or DLCO ≤70% predicted or RV≥120% predicted

• All patients must be postmenopausal females as defined by one of the following:

• Prior bilateral oophorectomy or bilateral ovarian irradiation.

• If age greater than 55 years, no menstrual period for 12 months or longer.

• If age 55 years or younger, must have an 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.

• Patients must have adequate 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) and SGOT (AST) < 2.5 X upper limit of normal

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.