livermetastases of uveal melanoma
Conditions
Interventions
Percutaneous hepatic perfusion is performed with 3 mg/kg melphalan in uveal melanoma liver metastases patients. This procedure uses an intravascular perfusion system to infuse the melphalan, to filter
Sponsors
LUMC, Leiden University Medical Centre
Eligibility
Inclusion criteria
Inclusion criteria: - Liver metastases only of histologically confirmed uveal melanoma - In case of resection of primary tumor, this should be > 1 month before PHP and has fully recovered from surgery. - Unresectable metastases confined to the liver based on CT-Thorax/abdomen and PET imaging - Metastases measurable on CT-scan meeting criteria for target lesion(s) by RECIST 1.1 - Candidate for neoadjuvant therapy as discussed in the multidisciplinary meeting to downsize the tumor - No or prior systemic chemotherapy for colorectal adenocarcinoma - Informed consent - Life expectancy > 4 months - Leukocytes ≥ 3.0 X 10^9/L - Thrombocytes ≥ 100 X 10^9/L - Creatinine clearance ≥ 60 ml/min - APTT < 32.5 sec - PT < 13.7 sec - Aspartate aminotransferase (AST [SGOT]) and alanine aminotransferase (ALT [SGPT]) ≤ 2.5 times ULN, (≤ 5 times ULN if considered due to tumor) - Serum bilirubin ≤ 1.5 times ULN - Alkaline phosphatase ≤ 2.5 times ULN, (≤ 5 times ULN in case of livermetastases)
Exclusion criteria
Exclusion criteria: - Biological age 65 years - WHO performance status ≥ 2 (Appendix A) - < 40% healthy liver tissue on CT - Aberrant vascular anatomy or lesions, which impede PHP (e.g. aberrant right or left hepatic artery, severe atherosclerosis, vascular dissections). Embolization may be used to re-distribute liver vasculature. - Prior Whipple’s surgery - Severe comorbidity (e.g. cardiovascular and pulmonary disease precluding general anaesthesia, diabetes with nephropathy, active infections, other liver disease) - Incompetent / Mentally disabled - Pregnancy, inadequate contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Objective response rate expressed as the RECIST 1.1 criteria (Appendix A) -Percentage of patients whose metastases turned into resectable ones | — |
Secondary
| Measure | Time frame |
|---|---|
| - Safety of percutaneous liver perfusion with the Delcath 2nd generation system - Overall survival, overall progression free survival and hepatic progression free survival - Duration of the response and duration of stable disease in patients with uveal melanoma metastases - Quality of life (QoL), according to the EORTC QLQ-C30 | — |
Contacts
Public ContactA.L. Vahrmeijer
Box 9600
Outcome results
None listed