Status:
COMPLETED
Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012
Lead Sponsor:
Centre Jean Perrin
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 \[131I\]ICF01...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03784625
Start Date
October 18 2019
End Date
January 17 2025
Last Update
February 13 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Jean Perrin
Clermont-Ferrand, France
2
CHU Clermont-Ferrand
Clermont-Ferrand, France