Loading clinical trials...

SILibinin in NSCLC and BC Patients With Single Brain METastasis (SILMET) | Clinical Trials | Clareo Health

RECRUITINGNA

SILibinin in NSCLC and BC Patients With Single Brain METastasis (SILMET)

A Phase 2 Randomized, Multicenter Trial on Silibinin To Prevent Intracranial Recurrence After Gross-Total Resection of Single Brain Metastasis From Non-Small Cell Lung Cancer or Breast Cancer

NCT05689619•A.O.U. Città della Salute e della Scienza

View on ClinicalTrials.gov

Summary

This study aims to evaluate the efficacy of silibinin in preventing recurrence in the brain after complete resection of a brain metastasis (BM) from non-small-cell lung cancer (NSCLC) or breast cancer (BC).

Detailed Description

This is the first placebo-controlled study evaluating the efficacy of silibinin as STAT3 inhibitor in preventing recurrence in the brain after gross-total resection of a brain metastasis (BM) from non-small-cell lung cancer (NSCLC) or breast cancer (BC). Participants will be randomized 1:1 to silibinin 1 g/day taken orally in comparison with oral placebo 1 g/day. A contrast-enhanced brain MRI will be performed every 8 weeks to evaluate intracranial local and distance recurrence

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed BM from NSCLC or BC by local pathology
•Single BM (maximum diameter of 3 cm) on MRI before surgery
•Complete surgical resection (MRI-verified within 14 days prior randomization)
•pSTAT3 score in reactive astrocytes of peritumoral tissue confirmed by local or central assessment
•patient must have recovered from the effects of surgery, including post-operative infection, suture/stample removal from brain surgery and wound healing before randomization
•≥ 18 - 70 years of age
•Karnofsky performance status ≥ 70 at assessment ≤ 14 days prior to randomization
•patient has adequate bone marrow, renal, and hepatic function ≤ 21 days prior to randomization as follows:
•1. absolute neutrophil count (ANC) ≥ 1500/mm3
•2. platelets ≥ 100000/ mm3
+14 more criteria

Exclusion Criteria

•Absence of expression of STAT3 on the reactive astrocytes of brain metastases
•Incomplete surgical resection and/or diameters \> 3 centimeters of brain metastasis before surgery
•Brain metastases that previously received any type of radiation therapy
•Progressive systemic disease requiring a change of the antineoplastic therapy
•Prior invasive malignancy (except for non-melanomatous skin cancer, oral cavity, or cervix) unless disease free for ≥ 2 years
•Prior, concomitant, or planned treatment with experimental agents
•Patients has had major immunologic reaction
•Patient has had a history of hypersensitivity to silibinin or excipient
•Patient is unsuitable to receive steroids
•Patient is a lactating or pregnant female
+15 more criteria

Locations (6)

Unità Operativa di Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino di Genova

Genova, Italy

Neurosurgery Unit, Department of Biomedical, Dental Science and Morphological and Functional Images, University of Messina

Messina, Italy

Institute of Neurosurgery, IRCCS Fondazione Policlinico Universitario Agostino Gemelli, Catholic University

Rome, Italy

Neuro-Oncology Unit, IRCCS Regina Elena National Cancer Institute

Rome, Italy

Precision Medicine in Breast Cancer Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Turin, Italy

Key Dates

Start Date

September 1, 2023

Primary Completion Date

September 1, 2025

Completion Date

September 1, 2027

Last Updated

December 15, 2023

Enrollment

ESTIMATED participants

Conditions

Brain Metastases, AdultNon Small Cell Lung CancerBreast Cancer

Interventions

Silibinin

DIETARY_SUPPLEMENT

Placebo

OTHER

Contacts

Pierangela Botta

CONTACT

+390116334904 botta.neuro.oncologia@gmail.com

Alessia Pellerino, M.D., Ph.D.

CONTACT

+390116334904 alessia.pellerino85@gmail.com

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

NCT04704661

Advanced Breast CarcinomaAdvanced Colon Carcinoma+38 more

View study

RECRUITINGPHASE2

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 15, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

SILibinin in NSCLC and BC Patients With Single Brain METastasis (SILMET)

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer