Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers (STBETA)
|ClinicalTrials.gov Identifier: NCT02104011|
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : January 23, 2018
Treatment of angiomyolipomas is based on invasive techniques such as surgery or embolization. Development of anti-angiogenic therapies is a major and growing field of research in hypervascularized tumors. Angiomyolipomas have been shown to regress after prolonged treatment with mTOR inhibitors (Sirolimus), but with a large proportion of secondary effects. We showed recently that beta-blockers were able to induce regression of infantile hemagiomas. Consequently, we looked for and found, histologically, in a few cases of angiomyolipomas the presence of beta2 receptors.
The aim of the study is to estimate if beta-blockers could induce regression or stabilization of renal angiomyolipomas in tuberous sclerosis in a pilot study.
|Condition or disease||Intervention/treatment||Phase|
|Renal Angiomyolipomas Tuberous Sclerosis||Drug: Propranolol||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers: Pilot Trial|
|Actual Study Start Date :||May 22, 2015|
|Primary Completion Date :||November 22, 2017|
|Study Completion Date :||November 22, 2017|
U.S. FDA Resources
|Experimental: Patient||Drug: Propranolol|
- Evolution of angiomyolipomas volume [ Time Frame: 6 months and 1 year after inclusion ]Stabilization or even regression of angiomyolipomas volume after 6 months and 1 year of treatment with a quantification of the vascular component.
- Renal function evolution [ Time Frame: 6 months and 1 year after inclusion ]Improvement of renal function after 6 months and 1 year of treatment
- Effect on the potential haemorraghic transformation [ Time Frame: 6 months and 1 year after inclusion ]Haemorraghic transformation of angiomyolipomas is diagnosed by Scanner or MRI.
- Improvement of the quality of life [ Time Frame: 6 months and 1 year after inclusion. ]Th evolution of the quality of life is assessed by an EVA scale and by QOL scale.
- Effect on face angiofibromas [ Time Frame: 6 months and 1 year after inclusion ]Evolution of the face angiofibromas by a dermatologic assessment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104011
|Principal Investigator:||Claire RIGOTHIER, Dr||UH Bordeaux|