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| ID | Type | Description | Link |
|---|---|---|---|
| TRANSLA12-143 | Other Grant/Funding Number | Ministry of Health, National Cancer Institute, France |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| therapeutic dose activity (level 1) | Experimental | [131]ICF01012 at a therapeutic dose of 800 MBq/m² , single dose at D11 (intravenous administration) |
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| therapeutic dose activity (level 2) | Experimental | [131]ICF01012 at a therapeutic dose of 1600 MBq/m² , single dose at D11 (intravenous administration) |
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| therapeutic dose activity (level 3) | Experimental | [131]ICF01012 at a therapeutic dose of 2700 MBq/m² , single dose at D11 (intravenous administration) |
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| therapeutic dose activity (level 4) | Experimental | [131]ICF01012 at a therapeutic dose of 4000 MBq/m² , single dose at D11 (intravenous administration) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [131I]ICF01012 (therapeutic dose level 1) | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the recommended therapeutic dose of [131I] ICF01012 | defined as the highest dose at which the percentage of DLT (dose limiting toxicity) is less than 33%. The DLT is defined as:
| Only toxicities observed during the 6 weeks following administration of the therapeutic dose will be considered for the evaluation of DLT |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the sensitivity and specificity by patients and by lesions of [131I]ICF01012 ICF01012 for the visualization of metastatic melanoma lesions from the examinations made during the selection phase | binding of [131I]ICF01012 compared to standard evaluation of metastatic lesion (standard imaging (CT Scan, TEP ...) or clinical evaluation) | selection phase Day 0 - Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florent CACHIN, Pr | Centre Jean Perrin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Jean Perrin | Clermont-Ferrand | France | ||||
| CHU Clermont-Ferrand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35428211 | Derived | Thivat E, Rouanet J, Auzeloux P, Sas N, Jouberton E, Levesque S, Billoux T, Mansard S, Molnar I, Chanchou M, Fois G, Maigne L, Chezal JM, Miot-Noirault E, D'Incan M, Durando X, Cachin F. Phase I study of [131I] ICF01012, a targeted radionuclide therapy, in metastatic melanoma: MELRIV-1 protocol. BMC Cancer. 2022 Apr 15;22(1):417. doi: 10.1186/s12885-022-09495-3. |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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dose escalation model
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| [131I]ICF01012 (therapeutic dose level 2) | Drug |
|
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| [131I]ICF01012 (therapeutic dose level 3) | Drug |
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| [131I]ICF01012 (therapeutic dose level 4) | Drug |
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| Evaluation of the tolerance of [131I] ICF01012 (adverse events assessed by NCI-CTC Version 4.03) | adverse events assessed by NCI-CTC Version 4.03 | from the the first dose to the end of study (3 months after diagnostic dose) |
| Pharmacokinetics of [131I] ICF01012 including the study of biodistribution and excretion (radiation counting of serum, whole blood and urinary samples) | radiation counting of serum, whole blood and urinary samples | selection phase Day 0 (diagnostic dose), Day 1, and Day 4, Day 7 |
| Evaluation of the therapeutic response of [131I] ICF01012. | Response will be categorized according to the criteria from RECIST 1.1 and PERCIST criteria: complete response, partial response, stable disease and progressive disease | at 3 months |
| Evaluation of personal dosimetry for the administration of [131I]ICF01012. | assessed by whole-body planar studies and tomographic imaging with single-photon emission computed tomography (SPECT)/CT | Selection phase : Day 0, Day 1, Day 4, and Day 7; therapeutic phase : Day 15, Day 18 and Day 25, Day 74 |
| Clermont-Ferrand |
| France |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |