Current Trials and Studies

Part of the mission of The LAM Foundation is to fund promising research. Our researchers need your help in order to conduct their research. Please see the open protocols below to see if you meet any of the requirements and find out how you can participate.

Study of the Disease Process of LAM - National Institutes of Health

Joel Moss, MD, PhD
CLICK HERE for more details.

Helen Green Research Travel Grant

Patients who are participating at the protocol at the NIH may be eligible to apply for the Helen Green Research Travel Grant. To learn more about the grant and the guidelines, check out the Helen Green Research Travel Fund Guidelines. You can apply for the grant by clicking here.

If you have any questions regarding this travel grant, please contact Anne McKenna, Patient Services & Education Manager at amckenna@thelamfoundation.org.

Safety and Efficacy of Saracatinib in Subjects with Lymphangioleiomyomatosis (SLAM-2)

N. Tony Eissa, MD at Baylor College of Medicine (main site for this multi-center study)
Women who are 18 years and older who have LAM are eligible to participate in this study. Subjects will be given 125 mg of saracatinib for up to nine months. The entire duration of the study is 12 months. Seven visits will be required throughout the study.

If you are interested in participating, please contact:

Caryn O. Pope, BSN, RRT, RCP
Clinical Research Coordinator
Baylor College of Medicine - Ben Taub General Hospital
(713) 873-2471 (office)
cpope@bcm.edu
CLICK HERE for more details about the study.

COLA: A Pilot Clinical Trial of COX-2 Inhibition in LAM and TSC

David Kwiatkowski, MD, PhD at Brigham and Women's Hospital
We will perform a pilot clinical trial to investigate the safety and tolerability of celecoxib therapy as a single agent for patients with LAM. LAM subjects who are not taking everolimus or rapamycin will be treated with celecoxib at 200mg PO QD for 6 months. They will be monitored for respiratory function and angiomyolipoma size. At the end of the 6 month period, celecoxib will be discontinued, and subjects will be monitored for another 6 months.
CLICK HERE for more details.

MIDAS Trial

Francis X. McCormack, MD at University of Cincinnati
The Multi-Center International Durability and Safety of Sirolimus in Lymphangioleiomyomatosis (MIDAS) trial continues to recruit patients eager to contribute to LAM research. This study aims to follow women with LAM who are currently taking, have previously failed or been intolerant of, or are considering treatment with mTOR inhibitors sirolimus or everolimus as part of their clinical care. There are currently seven participating LAM clinics with more to come. Over 100 patients have signed consent with the University of Cincinnati with the intention to eventually transfer to their LAM clinic or choice.
CLICK HERE for more details.

Upcoming Clinical Trials (Recruiting Soon)

Multicenter Interventional Lymphangioleiomyomatosis Early Disease (MILED)

Francis X. McCormack, MD at University of Cincinnati Medical Center
The primary objective of the MILD trial is to determine if early, long term (2 yr), low dose (fixed at 1 mg/day) treatment of patients with well-preserved lung function will prevent disease progression to more advanced stages. Sixty patients with FEV1>70% predicted will be enrolled and randomized to receive 1 mg/day sirolimus or placebo, and followed for a period of 2 years with pulmonary function testing every 4 months. The primary endpoint will be the between-group (placebo vs. sirolimus) difference in the rate of change in FEV1 (in liters) over two years. Secondary endpoints will include severity of adverse events, time to 200cc or 10% FEV1 decline, forced vital capacity, lung volumes, diffusing capacity, serum VEGF-D, and early airflow obstruction assessed using hyper-polarized gas MRI. Successful completion of this study will define the safety and efficacy of low dose sirolimus in patients with normal lung function, and determine if sirolimus can be used to prevent disease progression to symptomatic stages.Study sites: Palo Alto, CA, Denver, CO, Atlanta, GA, Chicago, IL, Boston, MA, St. Louis, MO, Cincinnati, OH, Cleveland, OH, Philadelphia, PA, Nashville, TN, Seattle, WA.
Click here for more details.

LAM Pilot Study with Imatinib Mesylate (LAMP-1)

Jeanine D'Armiento, MD, PhD at New York Presbyterian/Columbia
Dr. Charlie Strange, MD at Medical University of South Carolina
This is a double blind, adjusted parallel design, randomized clinical trial comparing imatinib mesylate 400 mg daily or matching placebo on the primary outcome of log transformed serum VEGF-D level in patients with LAM.
Sirolimus using patients will have co-administration of Imatinib mesylate or placebo for 28 days prior to sirolimus discontinuation.
The duration of 400 mg imatinib mesylate or placebo will be 56 days, a dose reduction is allowed for toxicity.The primary endpoint will be the change in the log transformed VEGF-D one month after monotherapy with imatinib mesylate or placebo.
Total trial duration is 2 months of drug administration.
Study site: Columbia University, New York, NY
Click here for more details.

Resveratrol and Sirolimus in LAM Trial (RESULT)

Nishant Gupta, MD at University of Cincinnati Medical Center
Francis X. McCormack, MD at University of Cincinnati Medical Center
Marina K. Holz, PhD at Yeshiva University
This is an open-label, phase II study of escalating doses or resveratrol in patients on a stable dose of sirolimus. 25 patients
will be enrolled. The primary endpoint will be to determine if there is a change in serum VEGF-D after 24 weeks of
combined Rsv and sirolimus as compared to the VEGF-D level in sirolimus alone. Secondary endpoints include PFTs, QOL
assessments, safety and adverse effect profiles.
Total trial duration is 3 years.
Study site: University of Cincinnati
Click here for more details.