Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012

Korábbi kezelés

• Previous treatment with chemotherapy, radiotherapy, immunotherapy and targeted therapy in the previous 4 weeks, the first injection of [131I] ICF01012
• Earlier irradiation of more than 25% of the bone marrow
• External Radiotherapy on target organs or the maximum dose as recommended in force

Más betegség

• Other evolutionary known cancer in the past five years
• Uncontrolled diabetes
• Known history of allergy to the excipients of the solution of [131I]ICF01012
• Any comorbidity or severe disease at the discretion of the investigator

Életkor

• Pregnant woman, nursing or woman of childbearing age refusing to follow effective contraception during treatment and 12 months after the administration of therapeutic dose.

Egyéb

• Brain metastases symptomatic
• Patient with a VI skin phototype
• Men refusing to follow effective contraception during treatment and 12 months after the administration of therapeutic dose
• Suspicion of invasion of more than 25% of the bone marrow on imaging 18F-FDG PET-CT

• Patient with metastatic melanoma failure to recommended treatments by HAS.
• Initial histological diagnosis of cutaneous melanoma pigmented or unknown status or choroidal melanoma.
• Presence of at least one measurable lesion and / or evaluable in 18FDG-PET as PERCIST criteria.
• Presence of at least one measurable lesion and / or evaluable as CT RECIST 1.1 criteria.
• WHO performance index ≤ 2 .
• Age\> 18 years
• Life expectancy\> 3 months.
• Creatinine ≤ 1,5 x ULN or creatinine clearance ≥ 60ml/min if creatinine \> 1,5 x ULN , Neutrophil \> 1,5.109L-1, Platellets \> 100 x 109L-1, prothrombine time \< 1,3 x control, Hemoglobin \> 9 g/dL, facteur V \> 80% (or AST, ALT ≤ 3 x LNS (≤ 5 x ULN if liver metastasis)).
• Normal cardiac fonction (LVEF\> 40%).