Clinical trial · Interventional
COLA: A Pilot Clinical Trial of COX-2 Inhibition in LAM and TSC
NCT02484664CI-TRIAL-00056047COLAcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphangioleiomyomatosis (LAM) | Lymphangioleiomyomatosis | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celecoxib | Drug | Celecoxib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- celecoxib
- description
- Celecoxib 200mg PO QD for 6 months
- interventionNames
- Drug: Celecoxib
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability
- timeFrame
- 1 year
- description
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability in LAM patients
Secondary outcomes (6)
- measure
- FEV1
- timeFrame
- 1 year
- description
- Forced expiratory volume in 1 second
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Female of age 18 to 69 * Ability to give informed consent * Definite diagnosis of LAM Typical cystic change on CT scan of the chest plus one of the following i) biopsy or cytology of any tissue demonstrating LAM, ii) angiomyolipoma, chylothorax, clinical or genetic diagnosis of tuberous sclerosis, iii) serum VEGF-D \> 800pg/ml * post-bronchodilator forced expiratory volume in one second ≥ 70% of predicted and DLCO ≥ 70% predicted during baseline visit. * Women of childbearing potential must agree to use two forms of barrier contraception after screening visit, for the duration of study participation and for 30 days after last dose. Exclusion Criteria: * History of intolerance to non-steroidal anti-inflammatory drugs (NSAIDs) * History of current regular use (daily most days of the week) of NSAIDs * History of use of rapamycin or everolimus * Uncontrolled intercurrent illness * Pregnant, breast feeding or planning to become pregnant in the next 2 years * Significant hematological (platelet count \<100.000/µl or hepatic abnormalities (Liver function tests \>2 times normal). * Use of an investigational drug within 30 days of study start * Inability to attend scheduled clinic visits * Inability to give informed consent * Inability to perform spirometry * Creatinine \> 1.0 mg/dl or eGFR \< 60 ml/min * Pneumothorax within past 8 weeks * History of malignancy in the last 2 years other than basal cell skin cancer * Use of estrogen containing medication within 30 days of enrolment * Currently taking doxycycline, metformin, lupron or simvastatin * Unable to undergo MRI * History of seizure within the last year * History of hepatitis or known active hepatitis B or C, or HIV positive serology * Angiomyolipoma of diameter \> 4 cm * History of vascular disease, including myocardial infarction or stroke * History of ulcers or GI bleeding * Allergy to sulfonamides, unless subject has previously used Celocoxib without any adverse reactions. * Age older than 70
References
Publications (1)
- DERIVEDEl-Chemaly S, Taveira-DaSilva A, Bagwe S, Klonowska K, Machado T, Lamattina AM, Goldberg HJ, Jones AM, Julien-Williams P, Maurer R, Rosas IO, Henske EP, Moss J, Kwiatkowski DJ. Celecoxib in lymphangioleiomyomatosis: results of a phase I clinical trial. Eur Respir J. 2020 May 27;55(5):1902370. doi: 10.1183/13993003.02370-2019. Print 2020 May. No abstract available. PMID 32060062