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NCT03784625CompletedEarly phase 1

Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012

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

Source: ClinicalTrials.gov · Last updated 13 Feb 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
10 (actual)
First submitted
18 Dec 2018
Start date
18 Oct 2019
Primary completion date
17 Jan 2025
Lead sponsor
Centre Jean Perrin
Diseases
Melanoma
NCT number
NCT03784625

What you commit to

  • Study type: Interventional · Early phase 1
  • Participants enrolled: 10
  • From 18 Oct 2019 to the primary completion date, 17 Jan 2025
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous treatment with chemotherapy, radiotherapy, immunotherapy and targeted therapy in the previous 4 weeks, the first injection of \[131I\] ICF01012
  • Earlier irradiation of more than 25% of the bone marrow
  • External Radiotherapy on target organs or the maximum dose as recommended in force

Other illness

  • Other evolutionary known cancer in the past five years
  • 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

Age

  • Pregnant woman, nursing or woman of childbearing age refusing to follow effective contraception during treatment and 12 months after the administration of therapeutic dose.

Other

  • Brain metastases symptomatic
  • Patient with a VI skin phototype
  • Men refusing to follow effective contraception during treatment and 12 months after the administration of therapeutic dose
  • Suspicion of invasion of more than 25% of the bone marrow on imaging 18F-FDG PET-CT

Who the study is looking for

  • 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%).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
CHU Clermont-Ferrand
Coordinator of this site? Confirm its status
Clermont-FerrandFranceUnknown status
Centre Jean Perrin
Coordinator of this site? Confirm its status
Clermont-FerrandFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.