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Spots Global Cancer Trial Database for Trial of Efficacy and Safety of Sirolimus in Tuberous Sclerosis and LAM

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Trial Identification

Brief Title: Trial of Efficacy and Safety of Sirolimus in Tuberous Sclerosis and LAM

Official Title: A Trial of the Efficacy and Safety of Sirolimus(Rapamycin)Therapy for Renal Angiomyolipmoas in Patients With Tuberous Sclerosis Complex and Sporadic Lymphangioleiomyomatosis

Study ID: NCT00490789

Interventions

sirolimus

Study Description

Brief Summary: The purpose of this study is to determine the safety and efficacy of the mTOR inhibitor sirolimus as a treatment for renal angiomyolipomas in patients with tyberous sclerosis complex or sporadic lymphangioleiomyomatosis.

Detailed Description: Inherited mutations of the TSC1 or TSC2 gene cause tuberous sclerosis while acquired (somatic) mutations of either gene are associated with sporadic lymphangioleiomyomatosis (LAM). Renal angiomyolipomas are a feature of both disorders. TSC1 and TSC2 regulate signalling through the mammalian target of rapamycin (mTOR) pathway. Inhibition of mTOR may result in a decrease in size of TSC 1/2 assciated lesions. We are treating patients with tuberous sclerosis or sporadic LAM with the mTOR inhibitor rapamycin in a non-randomised, open label pilot study of safety and efficacy. Change in size of renal angiomyolipomas is the primary end point

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University Hospital of Wales, Cardiff, Wales, United Kingdom

Royal Sussex County Hospital, Brighton, , United Kingdom

City Hospital, Nottingham, , United Kingdom

Contact Details

Name: Julian R Sampson, DM

Affiliation: Cardiff Univeristy

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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