Spots Global Cancer Trial Database for Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012

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Trial Identification

Brief Title: Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012

Official Title: Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012: Phase I Study

Study ID: NCT03784625

Conditions

Melanoma

Interventions

[131I]ICF01012 (therapeutic dose level 1)

[131I]ICF01012 (therapeutic dose level 2)

[131I]ICF01012 (therapeutic dose level 3)

[131I]ICF01012 (therapeutic dose level 4)

Study Description

Brief 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.

Detailed 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)