Actively Recruiting
SILibinin in NSCLC and BC Patients With Single Brain METastasis (SILMET)
Led by A.O.U. Città della Salute e della Scienza · Updated on 2023-12-15
70
Participants Needed
6
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
SILibinin in NSCLC and BC Patients With Single Brain METastasis (SILMET)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed brain metastasis from non-small-cell lung cancer or breast cancer
- Single brain metastasis with maximum size of 3 cm on MRI before surgery
- Complete surgical resection confirmed by MRI within 14 days before randomization
- Positive pSTAT3 score in reactive astrocytes near tumor confirmed by pathology
- Recovery from surgery effects including wound healing and removal of sutures/staples before randomization
- Age between 18 and 70 years
- Karnofsky performance status of 70 or higher within 14 days before randomization
- Adequate bone marrow, kidney, and liver function within 21 days before randomization:
- Absolute neutrophil count at least 1500/mm3
- Platelets at least 100000/mm3
- Hemoglobin at least 9.0 g/dl (transfusion allowed to meet this)
- Creatinine clearance at least 30 ml/min
- Total bilirubin no more than 1.5 times upper normal limit; exceptions for Gilbert's syndrome
- AST and ALT no more than 3 times upper normal limit
- Electrocardiogram showing no acute cardiac ischemia within 21 days before randomization
- Use of effective birth control methods during study and for 6 months after treatment for women of childbearing potential and men
- Negative pregnancy test within 7 days before randomization for women of childbearing potential
- Signed informed consent for biomarker testing and study participation
You will not qualify if you...
- No expression of STAT3 in reactive astrocytes of brain metastases
- Incomplete surgical removal or brain metastasis larger than 3 cm before surgery
- Previous radiation therapy to brain metastases
- Progressive systemic disease requiring change in cancer treatment
- Prior invasive cancer unless disease-free for 2 or more years (exceptions apply)
- Prior, concurrent, or planned treatment with experimental drugs
- History of major immune reactions
- Known allergy to silibinin or its components
- Unsuitable to receive steroid treatment
- Pregnant or breastfeeding women
- Severe active health conditions including:
- Severe liver impairment (Child-Pugh C or higher)
- Unstable angina or congestive heart failure in last 6 months
- Recent myocardial infarction or significant ECG changes
- Recent stroke or transient ischemic attack within 6 months
- Serious uncontrolled heart rhythm problems
- Active infections requiring IV antibiotics
- Severe respiratory illness requiring hospitalization
- AIDS-defining illnesses
- Active connective tissue diseases like lupus or scleroderma
- Other major medical or psychiatric conditions preventing treatment
- Participation in other therapeutic clinical trials within 30 days prior to study entry
- Inability to undergo contrast-enhanced MRI scans
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Unità Operativa di Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino di Genova
Genova, Italy
Not Yet Recruiting
2
Neurosurgery Unit, Department of Biomedical, Dental Science and Morphological and Functional Images, University of Messina
Messina, Italy
Actively Recruiting
3
Institute of Neurosurgery, IRCCS Fondazione Policlinico Universitario Agostino Gemelli, Catholic University
Rome, Italy
Not Yet Recruiting
4
Neuro-Oncology Unit, IRCCS Regina Elena National Cancer Institute
Rome, Italy
Not Yet Recruiting
5
Precision Medicine in Breast Cancer Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
Not Yet Recruiting
6
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Turin, Italy, 10126
Actively Recruiting
Research Team
P
Pierangela Botta
CONTACT
A
Alessia Pellerino, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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