Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers

• Status: Completed
• Trial end date: 2017-11-22
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Treatments: Adrenergic beta-Antagonists; Propranolol

Criteria

Inclusion Criteria:

• Tuberous sclerosis patients with one or several angiomyolipomas of a size of at least 4 cms.

Exclusion Criteria:

• Patients whom CT or MR scan shows one or several intra-lesional aneurisms requiring a preventive embolization.

• Patients with a retroperitoneal hemorragic complication requiring a preventive embolization.

• Patients whom biopsy will show an adenocarcinoma, hypertension non controlled, renal failure and severe liver.

• Diabetic subjects insufficiently controlled.

• Beta-blockers contra-indication.

• Psychosis, severe mental disorder.

• Patient already treated with beta-blockers or mTOR inhibitors.

• Pregnant or nursing women.