Current Clinical Trials and Studies

Part of the mission of The LAM Foundation is to support promising research and provide information about ongoing LAM clinical trials to patients. LAM researchers need patient participation to meet their research goals. Please review the open protocols below to learn more about how you can participate in LAM clinical research trials.

For a summary of all current trials and studies for LAM patients, CLICK HERE.

Ongoing Trials and Studies

The following trials and studies are ongoing and are open to most women with LAM. Please see the specific protocols below to determine if you are eligible to participate.

Study of the Disease Process of LAM - National Institutes of Health (NIH)plus

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:
Tania Machado, RN
Research Nurse Specialist, National Institutes of Health
(301)-496-3632 (o), (301)-661-1505(c)
tania.machado@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 at amckenna@thelamfoundation.org.

Tissue Donation - National Disease Research Interchange (NDRI)plus

National Disease Research Interchange (NDRI)
NDRI's Private Donor Program gives individuals and their families an opportunity to provide an invaluable resource for researchers working to discover and advance new treatments or cures. A variety of tissue samples from women with LAM, including lung, kidney, uterus, blood and chyle fluid are currently needed by LAM researchers. If you are having surgery and would be willing to make a tissue donation, or would like to learn more about the tissue donation process, please contact Anne McKenna at amckenna@thelamfoundation.org or (513) 777-6889.


Currently Enrolling Trials and Studies

Below you will find LAM clinical trials and studies that are currently enrolling. Please be sure to check the details of each open protocol to find out if you are eligible to participate. We encourage anyone who is considering enrollment in a clinical trial to contact the trial coordinator. They are very interested in talking to LAM patients and will provide detailed information so that you can decide what is best for you.

Discovery of Sirolimus Sensitive Biomarkers in Bloodplus

Joel Moss, MD, PhD, National Institutes of Health
This study is an observational study designed to determine if blood and urine markers after 1 dose and again after 3 months can be used to evaluate the correct dose of sirolimus for people with LAM. Women ages 18-90 with LAM whose doctors have decided they should start taking a 2 mg dose of sirolimus to treat it and who are able to travel to NIH are eligible to participate.

If you are interested in learning more, please contact:
Tania Machado, RN
Research Nurse Specialist, National Institutes of Health
(301)-496-3632 (o), (301)-661-1505 (c)
tania.machado@nih.gov

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

LAMP-1 - LAM Pilot Study with Imatinib Mesylateplus

Jeanine D'Armiento, MD, PhD at New York Presbyterian/Columbia
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. Click here for more details about the trial.

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.

MIDAS - Multi-Center International Durability and Safety of Sirolimus in LAMplus

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)
susan.mcmahan@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.

MILED - Multicenter Interventional LAM Early Diseaseplus

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)
susan.mcmahan@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.

RESULT - Resveratrol and Sirolimus in LAM Trialplus

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. Total trial duration is 3 years. CLICK HERE for more information about the study.

If you are interested in learning more, please contact:
Becky Ingledue
(513) 558-0027(o)
Rebecca.ingledue@uc.edu

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

SLAM-2 - Safety and Efficacy of Saracatinib in Subjects with LAMplus

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. Click here for more details about the study.

If you are interested in participating, please contact:
Melissa Brock
Clinical Research Coordinator
Baylor College of Medicine - Ben Taub General Hospital
(713) 873-8772 (office)
mbrock@bcm.edu
or
Nick Hanania, MD, MS
Director, Airways Clinical Research Center
Baylor College of Medicine
(713) 873-3454 (office)
hanania@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.


If you are a researcher looking for support from The LAM Foundation to promote your trial, please contact Laura Bowers at lbowers@thelamfoundation.org.