Neoplasms

All Conditions

Hemangioma

Perivascular Epithelioid Cell Neoplasms

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Neoplasms, Connective and Soft Tissue

Anti-Arrhythmia Agents

Antihypertensive Agents

Vasodilator Agents

All Drugs and Chemicals

Propranolol

Adrenergic beta-Antagonists

Patients who will have biopsy or surgery for Perivascular epithelioid cell tumor (PEComa) or vascular pediatric tumor (Rapidly Involuting Congenital Hemangioma (RICH), Non Involuting Congenital Hemangioma (NICH), hemangioma or pyogenic granuloma)

Biopsy

PEComa is rare tumor affecting particularly patients with Tuberous Sclerosis. Biological similarities were seen between PEComa and infantile hemangioma. Propranolol is highly efficient to treat infantile hemangioma and we believe that this drug can also be useful for the treatment of PEComa.

Purpose : to understand the mechanism of action of propranolol in PEComas and related pediatric vascular lesions and to select possible novel targets of betablockers in vascular tumors related to PEComas by using YAP oncogene activation as a molecular marker

Evaluation of New Biomarkers Predictive of Efficacy Betablockers in PEComa and Vascular Pediatric Tumors

Ministry for Health and Solidarity, France

National Cancer Institute, France

University Hospital, Bordeaux

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Recurrence

Melanoma

Disease Progression

Melanoma, Cutaneous Malignant

Skin Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Adrenergic Agents

Adrenergic Antagonists

Neurotransmitter Agents

113 patients will be enrolled in the placebo group with respect to randomization.

Placebo group will be prescribed placebo pills in the same packaging as propranolol treated group.

The frequency and duration of the treatment is the same as propranolol arm. The placebo group will have the same cardiology consultation as propranolol treated group to ensure the respect of blindness.

drug: 'Propranolol hydrochloride' 338 patients will be enrolled in the "Propranolol" Group and treated with propranolol.

The dosage will be determined by the cardiologist as the maximum tolerated dose to a maximum of 160mg/day.

One long acting pill a day until an evidence of disease progression or the end of the study.

This intervention apply to Propranolol group

Propranolol hydrochloride

We use placebo pills alike propranolol commercial pills to ensure blindness of the subjects during the study.

Placebo pill

Frédérique-Anne Le Gal, MD/PhD

Melanoma's incidence is increasing worldwide. The efforts made in melanoma screening led to an earlier detection of the primary tumour and a better prognosis, but melanoma remains an aggressive cancer when it comes to its metastatic stage. Three recent retrospective studies compared groups of patients diagnosed with primary melanoma and treated with betablockers for another indication to patients who never received betablockers. In these three studies, the outcome of the disease is significantly better for people under betablocker treatment with a decreased rate of recurrence and a better 5 years survival rate. Here we want to investigate the efficacy and the tolerability of an adjuvant treatment with propranolol for patients suffering from a primary melanoma with a high risk of recurrence.

Efficacy of Propranolol Treatment to Prevent Melanoma Progression

Phase 2 Prospective Study of the Efficacy of Propranolol on Malignant Melanoma Progression. A Randomized Placebo-controlled,Single Blind Trial

The efficacy of propranolol treatment will be tested in one interim analysis when the last patient enrolled have reached one year of follow up and one final analysis when the last patient enrolled have reached three years of follow up. The primary endpoint of the study will be the progression of the disease.

We will measure the efficacy of a propranolol treatment on the risk of progression of the disease.

We will investigate the microRNA profile in the serum of patients of both groups during the whole study to identify biomarkers specific for recurrence.

We investigate the impact of propranolol treatment on the 5 years survival.

University Hospital, Geneva

Associate Physician, PD, MD/PhD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of New Biomarkers Predictive of Efficacy Betablockers in PEComa and Vascular Pediatric Tumors	NCT02334930	PEComa Hemangioma	Biopsy	-	University Hospital, Bordeaux
Efficacy of Propranolol Treatment to Prevent Melanoma Progression	NCT01988831	Stages III Skin... Stages II Skin ... Stage IB Skin M...	Propranolol hyd... Placebo pill	18 Years -	University Hospital, Geneva

Spots Global Cancer Trial Database for betablocker

Every month we try and update this database with for betablocker cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for betablocker

Every month we try and update this database with for betablocker cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for betablocker cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.