Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers (STBETA)

University Hospital of Bordeaux

Status and phase

Completed

Phase 2

Conditions

Renal Angiomyolipomas

Tuberous Sclerosis

Treatments

Drug: Propranolol

Study type

Interventional

Funder types

Other

Identifiers

NCT02104011

CHUBX 2011/35

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.