CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Celecoxibdrug
Likely dose
Celecoxib 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02484664
NCT02484664Phase 2Completed
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COLA: A Pilot Clinical Trial of COX-2 Inhibition in LAM and TSC

Brigham and Women's Hospital·interventional·Posted Jun 30, 2015·Updated Jan 20, 2022

In Brief

A Phase 2 clinical trial evaluating Celecoxib for Lymphangioleiomyomatosis (LAM). Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphangioleiomyomatosis (LAM)
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 30, 2015
Enrollment StartJun 15, 2016
Primary CompletionNov 19, 2018
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 11.0 years ago

Interventions

Celecoxibdrug

We will perform a pilot clinical trial to investigate the safety and tolerability of celecoxib therapy as a single agent for patients with LAM. LAM subjects who are not taking everolimus or rapamycin will be treated with celecoxib at 200mg PO QD for 6 months. They will be monitored for respiratory function and angiomyolipoma size. At the end of the 6 month period, celecoxib will be discontinued, and subjects will be monitored for another 6 months.