Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012 (MELRIV-1)

Centre Jean Perrin

Status and phase: Completed; Early Phase 1

Conditions: Melanoma

Treatments: Drug: [131I]ICF01012 (therapeutic dose level 3); Drug: [131I]ICF01012 (therapeutic dose level 4); Drug: [131I]ICF01012 (therapeutic dose level 2); Drug: [131I]ICF01012 (therapeutic dose level 1)

Study type: Interventional

Funder types: Other

Identifiers

NCT03784625

TRANSLA12-143 (Other Grant/Funding Number)

2016-002444-17

Details and patient eligibility

About

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.

Full description

This study will include a maximum of 36 patients. This study will begin with a preselection part that consists of an injection of [131I]ICF01012 at a diagnostic dose (185 MBq) in order to preselect patients who will receive the therapeutic dose according to the dosimetry results : binding of [131I]ICF01012 on at least a tumoral lesion and an acceptable radiation absorbed dose to major organs.

The second phase will consist of a therapeutic part with a single administration of [131I]ICF01012 at a therapeutic dose. This part is a dose escalation model (4 levels of therapeutic dose were tested)

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.
• 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%).

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 4 patient groups

therapeutic dose activity (level 1)

Experimental group

Description:

\[131\]ICF01012 at a therapeutic dose of 800 MBq/m² , single dose at D11 (intravenous administration)

Treatment:

Drug: [131I]ICF01012 (therapeutic dose level 1)

therapeutic dose activity (level 2)

Experimental group

Description:

\[131\]ICF01012 at a therapeutic dose of 1600 MBq/m² , single dose at D11 (intravenous administration)

Treatment:

Drug: [131I]ICF01012 (therapeutic dose level 2)

therapeutic dose activity (level 3)

Experimental group

Description:

\[131\]ICF01012 at a therapeutic dose of 2700 MBq/m² , single dose at D11 (intravenous administration)

Treatment:

Drug: [131I]ICF01012 (therapeutic dose level 3)

therapeutic dose activity (level 4)

Experimental group

Description:

\[131\]ICF01012 at a therapeutic dose of 4000 MBq/m² , single dose at D11 (intravenous administration)

Treatment:

Drug: [131I]ICF01012 (therapeutic dose level 4)