Lymphangioleiomyomatosis Clinical Trial
— LAMP-1Official title:
LAM Pilot Study With Imatinib Mesylate
Verified date | June 2020 |
Source | Medical University of South Carolina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a phase 1 clinical trial comparing imatinib mesylate to placebo for individuals with lymphangioleiomyomatosis (LAM).
Status | Completed |
Enrollment | 18 |
Est. completion date | March 7, 2019 |
Est. primary completion date | March 7, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Definite or Probable LAM - FVC or Postbronchodilator FEV1 <90% predicted Exclusion Criteria: - Current or planned pregnancy or lactation - Unwillingness to discontinue sirolimus - Change in the dose or use of sirolimus within the past month - Inability to perform spirometry - Allergy or intolerance of albuterol and/or ipratropium - Other serious illness that would impact the outcome of the study including cancer that has not received curative therapy, Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study), uncontrolled diabetes, chronic renal disease, chronic liver disease, or active uncontrolled infection - Current lung transplant - Known diagnosis of human immunodeficiency virus (HIV) infection - Current cigarette smoking - Required use of warfarin, ketoconazole, itraconazole, clarithromycin, or rifampin during the 2 months of the study. - Unwillingness to avoid grapefruit juice or St. Johns Wort during the study. - Planned surgery during the 2 months of the study. - Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent. - Patient has received and other investigational agents within 28 days of first day of study drug dosing. |
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Columbia University | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina | Columbia University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Lung Function | FEV1 % predicted change | 2 months | |
Other | SGRQ | Saint Georges Respiratory Questionnaire change | 2 months | |
Primary | Serum VEGF-D | Change in the square root of the intrasubject plasma VEGF-D | Before and 1 month after initiation of monotherapy imatinib mesylate or placebo | |
Secondary | Adverse Events | Adverse event and Serious Adverse Event numbers using the CTCAE Version 4.03 definitions | 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01687179 -
Safety Study of Sirolimus and Hydroxychloroquine in Women With Lymphangioleiomyomatosis
|
Phase 1 | |
Completed |
NCT00366509 -
Role of Helicobacter Pylori and Its Toxins in Lung and Digestive System Diseases
|
||
Completed |
NCT00552955 -
Effect of Fasting on the Size of Abdominal Lymphatic Tumors in Women
|
||
Unknown status |
NCT00490789 -
Trial of Efficacy and Safety of Sirolimus in Tuberous Sclerosis and LAM
|
Phase 2 | |
Not yet recruiting |
NCT05087134 -
Characterizing LAM With 11C-Choline PET/CT
|
Early Phase 1 | |
Completed |
NCT02009241 -
Pulmonary Rehabilitation in Lymphangioleiomyomatosis
|
N/A | |
Recruiting |
NCT05190627 -
Effect of Loratadine in Lymphangioleiomyomatosis
|
Phase 2 | |
Completed |
NCT05323370 -
Lymphangioleiomyomatosis, a Study on Cathepsin K
|
||
Completed |
NCT02859194 -
The Effect of Lt to Rt Shunt Using Veno-veno-arterial Extracorporeal Membrane Oxygenation (ECMO) on Coronary Oxygenation in Lung Transplantation Patients
|
N/A | |
Completed |
NCT01353209 -
Letrozole for Lymphangioleiomyomatosis
|
Phase 2 | |
Completed |
NCT03253913 -
Resveratrol and Sirolimus in Lymphangioleiomyomatosis Trial
|
Phase 2 | |
Recruiting |
NCT02432560 -
Safety and Durability of Sirolimus for Treatment of LAM
|
||
Completed |
NCT02061397 -
Safety of Simvastatin in LAM and TSC
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT01552434 -
Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease
|
Phase 1 | |
Recruiting |
NCT04577937 -
Sleep Patterns in Patients Affected by Lymphangioleiomiomatosis
|
N/A | |
Completed |
NCT00005906 -
Treatment With Octreotide in Patients With Lymphangioleiomyomatosis
|
Phase 2 | |
Recruiting |
NCT01799538 -
Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis
|
Phase 1/Phase 2 | |
Completed |
NCT00989742 -
Doxycycline In Lymphangioleiomyomatosis (LAM)
|
Phase 4 | |
Recruiting |
NCT06160310 -
Tuberous Sclerosis Complex and Lymphangioleiomyomatosis Pregnancy Registry (TSC-LAM Registry)
|
||
Enrolling by invitation |
NCT05727852 -
Breath Analysis and Arterial Stiffness in Patients With Respiratory Diseases
|