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NCT Number: NCT03784625

Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012

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.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

CHU Clermont-Ferrand, Clermont-Ferrand, France

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[131I]ICF01012 (therapeutic dose level 1)

Drug
  • 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 2)

Drug
  • 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 3)

Drug
  • 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 4)

Drug
  • 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

Primary outcomes

  1. Evaluation of the recommended therapeutic dose of [131I] ICF01012

    Time frame: Only toxicities observed during the 6 weeks following administration of the therapeutic dose will be considered for the evaluation of DLT

    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

Secondary outcomes

  1. 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

    Time frame: selection phase Day 0 - Day 7

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

  2. Evaluation of the tolerance of [131I] ICF01012 (adverse events assessed by NCI-CTC Version 4.03)

    Time frame: from the the first dose to the end of study (3 months after diagnostic dose)

    adverse events assessed by NCI-CTC Version 4.03

  3. Pharmacokinetics of [131I] ICF01012 including the study of biodistribution and excretion (radiation counting of serum, whole blood and urinary samples)

    Time frame: selection phase Day 0 (diagnostic dose), Day 1, and Day 4, Day 7

    radiation counting of serum, whole blood and urinary samples

  4. Evaluation of the therapeutic response of [131I] ICF01012.

    Time frame: at 3 months

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

  5. Evaluation of personal dosimetry for the administration of [131I]ICF01012.

    Time frame: Selection phase : Day 0, Day 1, Day 4, and Day 7; therapeutic phase : Day 15, Day 18 and Day 25, Day 74

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

Sponsors and collaborators

Lead sponsor

Centre Jean Perrin

Other

Registry information

Official study title

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

Acronym: MELRIV-1

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Dec 24, 2018
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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