Patient case: 70-year-old male with melanoma; genetic feature: NF1 truncation

Clinical trial: Study Multicentre Evaluating the Effectiveness and Toxicity Sorafenib (Nexavar®) in Adult Patients With Uveal Melanoma and Metastatic Dissemination

Summary: The objective of the study is to determine the efficacy and toxicity of sorafenib in metastatic uveal melanoma.
  The main objective is to determine the non-tumor progression rate 24 weeks after initiation of treatment with sorafenib at a dose of 800 mg / day


Eligibility: Inclusion Criteria:
  -  Male or female over 18 years old suffering from uveal melanoma with metastasis
  -  At least one measurable metastases by more than 10 mm acoording to Response Evaluation Criteria in Solid Tumors (RECIST)
  -  At least 28 days from the previous treatment (systemic or major surgery)
  -  Performance Index (WHO ≤ 2 or ≥ 70% Karnofsky)
  -  Weight loss compared to pre morbid weight <20% in the last 12 months
  -  White blood cells at least 3000 / mm 3, polynuclear neutrophils less than 1500 / mm3, platelets at least 100,000 / mm3, hemoglobin at least 9.0 g / dl
  -  Total Bilirubin ≤1.5 x upper limit of normal (ULN) (or less than or equal to 2.5 in liver metastasis), ASAT and ALAT ≤ 2.5 x ULN (or ≤ 5 in liver metastasis) Serum Creatinine (calculated using the cockcroft-Gault method) ≤ 1.5 x ULN, Amylase and lipase <1.5 x ULN
  -  prothrombin rate and international normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN. Possibility of using low molecular weight heparin in place of anti vitamin K treatment
  -  higher life expectancy than or equal to 3 months
  -  Negative pregnancy test for women of childbearing age and using a method of contraception during treatment
  -  No one benefiting from a Social Security scheme
  -  Informed consent and signed by the patient or his legal representative
  Exclusion Criteria:
  -  • Patient who received more than 2 lines of treatment (chemotherapy or immunotherapy), whatever the indication
  -  Major surgery (excluding the possible diagnostic biopsy) or radiation therapy in the 4 weeks preceding the inclusion
  -  single liver metastasis treatable by surgery
  -  active peptic ulcer, uncontrolled
  -  Other progressive malignancy or during treatment (except basal cell carcinoma)
  -  Cardiac arrhythmias requiring anti-arrhythmic (excluding beta-blockers or digoxin for chronic atrial fibrillation), active or ischemic coronary disease (myocardial infarction within the last 6 months), or heart failure> New York Heart Association (NYHA) class II
  -  Bacterial or fungal infection active (grade> 2 Common Toxicity Criteria for Adverse Effects (CTCAE) v4.03)
  -  known HIV infection or chronic hepatitis B or C
  -  cerebral or meningeal tumor metastasis (symptomatic or asymptomatic)
  -  epileptic disease requiring anti-epileptic taken
  -  Previous history of organ transplantation or peripheral stem cells
  -  Patient kidney dialysis
  -  Concomitant treatment with cytochrome P450 3A4 (CYP3A4) inducers such as rifampin, St. John's wort, phenytoin, carbamazepine, phenobarbital and dexamethasone
  -  Prior therapy with bevacizumab or other targeted therapy
  -  Known or suspected allergy to sorafenib
  -  Any unstable chronic illness can jeopardize patient safety or its compliance
  -  Women pregnant or lactating
  -  coagulopathy
  -  Uncontrolled hypertension
  -  Inability to swallow
  -  Failure to submit to medical monitoring of the trial due to geographical, social or psychic
  -  Persons deprived of liberty or under supervision
  -  Patient refusing ambulatory care
  -  Patient simultaneously participating in another clinical trial

Relevance to patient case: not relevant