Status:
COMPLETED
Resveratrol and Sirolimus in Lymphangioleiomyomatosis Trial
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Lymphangioleiomyomatosis
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RESULT is a phase II dose-escalating, open-label, safety and efficacy study to determine if there is a potential benefit of resveratrol in combination with sirolimus in patients with lymphangioleiomyo...
Detailed Description
Study Design RESULT was an open label, dose-escalation, phase 2 study with longitudinal repeated measures. In order to be eligible for trial inclusion, patients had to satisfy all of the following cri...
Eligibility Criteria
Inclusion
- Subjects enrolled in the trial must meet all of the following criteria.
- Definitive diagnosis LAM based on the presence of characteristic cystic change on high-resolution computed tomography (HRCT) of the chest. The diagnosis must be confirmed by one of the following:
- A) Histopathological confirmation by biopsy (lung, abdominal mass, lymph node or kidney or cytology from thoracic or abdominal sources revealing human melanoma black-45 (HMB45)+ staining of spindled/epithelioid cells) B) Compatible chest CT scan findings in the setting of tuberous sclerosis, angiomyolipomas (diagnosed by CT, magnetic resonance imaging (MRI) by the site radiologist or biopsy) or chylous pleural effusion (verified by tap) C) Chest CT scan findings compatible with LAM and a VEGF-D level ≥ 800pg/ml.
- Age 18 years or greater.
- Signed and dated informed consent
- Currently on sirolimus for treatment of LAM for at least 20 weeks
- Evidence of disease stabilization on sirolimus as demonstrated by two stable values of serum VEGF-D post initiation of sirolimus drawn at least 12 weeks apart from each other. For the purpose of this study, a variation in serum VEGF-D of less than or equal to 15% is considered stable.
Exclusion
- Subjects who meet any of the following criteria are not eligible for enrollment as study participants:
- Known allergy or hypersensitivity to Resveratrol
- Inability to provide informed consent
- Active enrollment in other clinical drug trials for LAM
- Pregnant or plan to become pregnant in the next 6 months
- Breast feeding
- Inability to comply with pulmonary function tests or follow up visits
- Inadequate contraception
- Use of estrogen containing medications within the 30 days prior to randomization
- History of organ transplant
- Actively listed for lung transplantation
- Inability to comply with study procedures or attend scheduled study visits
- Any clinically significant medical disease (other than LAM) that is associated with an expected survival of less than 2 years, or likely to impact the ability of the patient to participate in the study in the opinion of the investigator, or impact the study efficacy or safety assessments.
Key Trial Info
Start Date :
March 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03253913
Start Date
March 31 2018
End Date
October 15 2022
Last Update
February 1 2023
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45267