Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012
MELRIV-1
2 other identifiers
interventional
10
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Oct 2019
Longer than P75 for early_phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2018
CompletedFirst Posted
Study publicly available on registry
December 24, 2018
CompletedStudy Start
First participant enrolled
October 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2025
CompletedFebruary 13, 2025
February 1, 2025
5.3 years
December 18, 2018
February 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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: * 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
Only toxicities observed during the 6 weeks following administration of the therapeutic dose will be considered for the evaluation of DLT
Secondary Outcomes (5)
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
selection phase Day 0 - Day 7
Evaluation of the tolerance of [131I] ICF01012 (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)
selection phase Day 0 (diagnostic dose), Day 1, and Day 4, Day 7
Evaluation of the therapeutic response of [131I] ICF01012.
at 3 months
Evaluation of personal dosimetry for the administration of [131I]ICF01012.
Selection phase : Day 0, Day 1, Day 4, and Day 7; therapeutic phase : Day 15, Day 18 and Day 25, Day 74
Study Arms (4)
therapeutic dose activity (level 1)
EXPERIMENTAL\[131\]ICF01012 at a therapeutic dose of 800 MBq/m² , single dose at D11 (intravenous administration)
therapeutic dose activity (level 2)
EXPERIMENTAL\[131\]ICF01012 at a therapeutic dose of 1600 MBq/m² , single dose at D11 (intravenous administration)
therapeutic dose activity (level 3)
EXPERIMENTAL\[131\]ICF01012 at a therapeutic dose of 2700 MBq/m² , single dose at D11 (intravenous administration)
therapeutic dose activity (level 4)
EXPERIMENTAL\[131\]ICF01012 at a therapeutic dose of 4000 MBq/m² , single dose at D11 (intravenous administration)
Interventions
* 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
* 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
* 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
* 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
Eligibility Criteria
You may qualify if:
- 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%).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Centre Jean Perrin
Clermont-Ferrand, France
CHU Clermont-Ferrand
Clermont-Ferrand, France
Related Publications (1)
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.
PMID: 35428211DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Florent CACHIN, Pr
Centre Jean Perrin
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2018
First Posted
December 24, 2018
Study Start
October 18, 2019
Primary Completion
January 17, 2025
Study Completion
January 17, 2025
Last Updated
February 13, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share