Overview

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

Status:
Completed
Trial end date:
2020-06-01
Target enrollment:
Participant gender:
Summary
The investigators will perform a two-center phase I trial of celecoxib (COX-2 inhibitor) administered at 200mg by mouth daily for 6 months. Up to 12 adult women with LAM will be recruited (between 4-8 at each site). The Specific Aims are: Aim 1: To investigate whether, in LAM patients, celecoxib is safe and well tolerated, and has evidence of clinical benefit. Aim 2: To investigate the potential value of a novel biomarker of LAM, quantitative measurement of the number of TSC2 mutant LAM cells per ml of blood, to assess disease severity.
Phase:
Phase 2
Details
Lead Sponsor:
Brigham and Women's Hospital
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Treatments:
Celecoxib