Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012

• Status: Recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a phase I clinical trial aimed to determine the recommended dose of [131I]ICF01012 to administer for the treatment of patients with pigmented metastatic melanoma (binding [131I]ICF01012 ). The [131I]ICF01012 is a targeted radionuclide therapy with a high affinity for melanin.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Jean Perrin

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