Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012 (MELRIV-1)
Melanoma
About this trial
This is an interventional treatment trial for Melanoma focused on measuring metastatic melanoma, targeted radionuclide therapy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Brain metastases symptomatic
- Patient with a VI skin phototype
- Previous treatment with chemotherapy, radiotherapy, immunotherapy and targeted therapy in the previous 4 weeks, the first injection of [131I] ICF01012
- Pregnant woman, nursing or woman of childbearing age refusing to follow effective contraception during treatment and 12 months after the administration of therapeutic dose.
- Men refusing to follow effective contraception during treatment and 12 months after the administration of therapeutic dose
- Other evolutionary known cancer in the past five years
- Earlier irradiation of more than 25% of the bone marrow
- Suspicion of invasion of more than 25% of the bone marrow on imaging 18F-FDG PET-CT
- External Radiotherapy on target organs or the maximum dose as recommended in force
- 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
Sites / Locations
- Centre Jean PerrinRecruiting
- CHU Clermont-FerrandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
therapeutic dose activity (level 1)
therapeutic dose activity (level 2)
therapeutic dose activity (level 3)
therapeutic dose activity (level 4)
[131]ICF01012 at a therapeutic dose of 800 MBq/m² , single dose at D11 (intravenous administration)
[131]ICF01012 at a therapeutic dose of 1600 MBq/m² , single dose at D11 (intravenous administration)
[131]ICF01012 at a therapeutic dose of 2700 MBq/m² , single dose at D11 (intravenous administration)
[131]ICF01012 at a therapeutic dose of 4000 MBq/m² , single dose at D11 (intravenous administration)