Liver Metastases from Uveal Melanoma
Conditions
Interventions
Trade Name: Cisplatin Neo Corp® 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung
Product Name: Cisplatin
Product Code: 39021.01.00
Pharmaceutical Form: Solution for injection/infusion
INN or
Sponsors
Charité – Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female patients = 18 years of age • ECOG PS of 0, 1 or 2 • Histologically or cytologically confirmed liver metastases of uveal melanoma • At least one measurable lesion according to RECIST criteria v1.1 determined MRI (if contraindications against MRI exist CT with contrast media can is allowed) • Metastases in other sides are allowed if not in need of treatment (e.g. asymptomatic bone metastasis without indication for radiation) • Life expectancy > 3 months • Signed informed consent • The following laboratory parameters must be met at time of inclusion: o Total bilirubin =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Surgically treatable liver metastases Previous intraarterial hepatic treatment (e.g. radioemolization, chemoembolization, intraarterial chemotherapy, isolated or percutaneous hepatic perfusion) Previous treatment with external liver radiation Major intrahepatic occlusion of the portal vein and/or tumor infiltration of the portal vein Liver cirrhosis Child-Pugh C Other malignancy and/or metastases in need of treatment Current treatment with any anti-cancer therapy One of the following existing medical conditions: o Unstable cardiac disease despite treatment, congestive heart failure NYHA grade > II, malignant cardiac arrhythmia o Significant neurologic or psychiatric disorders including dementia o Active uncontrolled infection o Active disseminated intravascular coagulation o Active bleeding diathesis or patients on oral anti-vitamin-K medication or comparable coagulation influencing medication (such as thrombin inhibitors as dabigatran or direct Factor Xa inhibitors as rivaroxaban or apixaban) o Known history of HIV seropositivity or Hepatitis B or C infection o Any other severe and/or uncontrolled medical conditions which could impair the ability of the patient to participate in the study • Pregnancy (absence confirmed by serum ß-HCG test) or breast-feeding • Known allergic reactions or hypersensitivity to any of the components of the treatment • Legal incapacity or limited legal capacity or existing medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or to sign meaningful informed consent • Accommodation in an institution under officially or judicially orders (§40 p.1 No. 4 AMG) • Participation in an interventional study in the last 30 days before inclusion in this trial • Employees of the study site are excluded from participation in the trial (§40 subparagraph 1 No. 3b AMG)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is a randomized phase II trial to evaluate the relative efficacy of transarterial radioembolization with yttrium-90 microspheres (SIRT) in comparison to standard treatment with transarterial chemoembolization with cisplatin (DSM-TACE) in patients with liver metastases due to advanced uveal melanoma in terms of progression-free survival. ;Secondary Objective: To compare quality of life during treatment and feasibility of the two treatment options.;Primary end point(s): Progression-free survival (PFS);Timepoint(s) of evaluation of this end point: Every 6 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Hepatic response (CR + PR) • Toxicity • Disease control (PR + CR + SD) • Hepatic progression-free survival (PFS-L) • Overall survival (OS) • Quality of Life (QoL) ;Timepoint(s) of evaluation of this end point: Interrim analysis after 20 patients have been accrued to each study arm and final analysis after inclusion of 45 patients in each study arm (total of 90 patients). | — |
Countries
Germany
Contacts
Public ContactCharité Comprehensive Cancer Center
Charité - Universitätsmedizin Berlin
Outcome results
None listed