Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

\[131\]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)

* 1 diagnostic injection (D0) at a diagnostic dose of 185 MBq. This first dose permits to pre-select patients who will received a therapeutic dose according to the dosimetry results ( binding on at least a tumoral lesion, an acceptable radiation absorbed dose to major organs)
* 1 therapeutic injection (D11) at a dose of 800 MBq/m²

[131I]ICF01012 (therapeutic dose level 1)

* 1 diagnostic injection (D0) at a diagnostic dose of 185 MBq. This first dose permits to pre-select patients who will received a therapeutic dose according to the dosimetry results ( binding on at least a tumoral lesion, an acceptable radiation absorbed dose to major organs)
* 1 therapeutic injection (D11) at a dose of 1600 MBq/m²

[131I]ICF01012 (therapeutic dose level 2)

* 1 diagnostic injection (D0) at a diagnostic dose of 185 MBq. This first dose permits to pre-select patients who will received a therapeutic dose according to the dosimetry results ( binding on at least a tumoral lesion, and an acceptable radiation absorbed dose to major organs)
* 1 therapeutic injection (D11) at a dose of 2700 MBq/m²

[131I]ICF01012 (therapeutic dose level 3)

* 1 diagnostic injection (D0) at a diagnostic dose of 185 MBq. This first dose permits to pre-select patients who will received a therapeutic dose according to the dosimetry results ( binding on at least a tumoral lesion, and an acceptable radiation absorbed dose to major organs)
* 1 therapeutic injection (D11) at a dose of 4000 MBq/m²

[131I]ICF01012 (therapeutic dose level 4)

Florent CACHIN, Pr

Florent Cachin, Pr

Sandrine Mansard, MD

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.

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)

Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012

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

defined as the highest dose at which the percentage of DLT (dose limiting toxicity) is less than 33%. The DLT is defined as:

* all non hematologic toxicities NCI-CTC grade 3-4 except for alopecia, nausea, vomiting and fever that can be controlled by appropriate measures.
* hematologic toxicities as thrombopenia and anemia of grade 4, neutropenia of grade 4 for more than 5 days, thrombopenia of grade 3 with bleeding and all other hematologic toxicities of grade 3 clinically significant of more than 3 weeks

binding of \[131I\]ICF01012 compared to standard evaluation of metastatic lesion (standard imaging (CT Scan, TEP ...) or clinical evaluation)

adverse events assessed by NCI-CTC Version 4.03

radiation counting of serum, whole blood and urinary samples

Response will be categorized according to the criteria from RECIST 1.1 and PERCIST criteria: complete response, partial response, stable disease and progressive disease

assessed by whole-body planar studies and tomographic imaging with single-photon emission computed tomography (SPECT)/CT

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012	NCT03784625	Melanoma	[131I]ICF01012 ... [131I]ICF01012 ... [131I]ICF01012 ... [131I]ICF01012 ...	18 Years -	Centre Jean Perrin
Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012	NCT03784625	Melanoma	[131I]ICF01012 ... [131I]ICF01012 ... [131I]ICF01012 ... [131I]ICF01012 ...	18 Years -	Centre Jean Perrin

Spots Global Cancer Trial Database for [131i]icf01012 (therapeutic dose level 4)