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
This study is designed to determine the disease processes involved at the level of cells and molecules to develop more effective therapies for LAM. Researchers intend to identify the proteins and genes that contribute to the process of lung destruction in affected individuals.

If you are interested in learning more, please contact:
Andrew Keel, RN
Research Nurse Specialist, National Institutes of Health
(301)-496-3632 (o), (301)-648-5674 (c)
andrew.keel@nih.gov
or
Sara Hauff, RN
Research Nurse Specialist, National Institutes of Health
(301)-496-3632 (o)
sara.hauff@nih.gov

Study site: Bethesda, MD
Visit https://clinicaltrials.gov and search for the title of this study 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 LAM (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 saracatnib 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

Study sites: Houston, TX; Palo Alto, CA; Chicago, IL; Boston, MA; Cincinnati, OH; Bethesda, MD
Visit https://clinicaltrials.gov and search for the title of this study for more details.

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

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.

If you are interested in learning more please contact:
Shefali Bagwe, MBBS
Clinical Research Coordinator, Brigham and Women’s Hospital
(857) 307-0784 (o)
sbagwe@partners.org
or
Andrew Keel, RN
Research Nurse Specialist, National Institutes of Health
(301)-496-3632 (o), (301)-648-5674 (c)
andrew.keel@nih.gov

Study site: Boston, MA and Bethesda, MD
Visit https://clinicaltrials.gov and search for the title of this study for more details.

Multi-Center International Durability and Safety of Sirolimus in LAM (MIDAS) Trial

Francis X. McCormack, MD at University of Cincinnati
The 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. All patients with LAM are eligible. Women with TSC over the age of 18 are eligible whether lung cysts are present are not. There are currently 17 participating LAM clinics with more to come. Over 150 patients have signed consent with the University of Cincinnati with the intention to eventually transfer to their LAM clinic of choice.

If you are interested in learning more, please contact:
Sue McMahan
LAM Research Program Manager, University of Cincinnati College of Medicine
(513) 558-4376 (o)
mcmahansn@ucmail.uc.edu

Study sites: Palo Alto, CA, Denver, CO, Atlanta, GA, Chicago, IL, Boston, MA, Ann Arbor, MI, Rochester, MN, St. Louis, MO, Rochester, NY, Cincinnati, OH, Cleveland, OH, Philadelphia, PA, Charleston, SC, Nashville, TN, Dallas, TX, Houston, TX, Salt Lake City, UT, Seattle, WA.
Visit https://clinicaltrials.gov and search for the title of this study for more details.


Upcoming Clinical Trials (Recruiting Soon)


Multicenter Interventional LAM Early Disease (MILED) Trial

Francis X. McCormack, MD at University of Cincinnati Medical Center
The primary objective of the MILED 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 air flow obstruction assessed using hyper-polarized gas MRI. Successful completion of this study will de ne 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.

If you are interested in learning more, please contact:
Sue McMahan
LAM Research Program Manager, University of Cincinnati College of Medicine
(513) 558-4376 (o)
mcmahansn@ucmail.uc.edu

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.
Visit https://clinicaltrials.gov and search for the title of this study 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 400mg 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.

If you are interested in learning more, please contact:
Kimberly Brown, MS
Study Coordinator, Medical University of SC
Charleston, SC
(843) 792-6474 (o)
brownkl@musc.edu
OR
Laura Fonseca, BA
Clinical Coordinator, New York Presbyterian
New York, NY
(212) 305-3745 (o)
lf2560@cumc.columbia.edu

Study sites: New York, NY and Charleston, SC
Visit https://clinicaltrials.gov and search for the title of this study 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 of resveratrol in patients on a stable dose of sirolimus. Twenty-five 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 resveratrol and sirolimus as compared to the VEGF-D level in sirolimus alone. Secondary endpoints include PFTs, QOL assessments, safety and adverse effect profiles. Key inclusion criterion: LAM patients on sirolimus for at least 20 weeks, with stabilization of VEGF-D levels post sirolimus as tested by at least 2 lab draws at least 12 weeks apart.
Projected start date: Nov/Dec 2017. Total trial duration is 3 years.

If you are interested in learning more, please contact:
Nathan Robbins, MS
Research Coordinator, University of Cincinnati College of Medicine
(513) 558-0237 (o)
nathan.robbins@uc.edu

Study site: Cincinnati, OH
Visit https://clinicaltrials.gov and search for the title of this study for more details.

For more information about participating in research and what you can expect, please visit www.hhs.gov/About-Research-Participation.