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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional




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

Brief 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.