No registrations found.
ID
Source
Health condition
livermetastases of uveal melanoma
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Objective response rate expressed as the RECIST 1.1 criteria (Appendix A)
- Percentage of patients whose metastases turned into resectable ones
Secondary outcome
- 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
Background summary
In this phase II trial patients with unresectable isolated hepatic metastases of uveal melanoma will be included to receive percutaneous hepatic perfusion (PHP) using Melphalan, this perfusion will be performed twice or more.
Study objective
Isolated liver perfusion has the advantage of controlling liver disease and decreasing treatment related symptoms and complications. This phase
II trial aims to study the effectiveness and safety of the PHP treatment with Melphalan in patients with unresectable liver metastases.
Study design
6 weeks after the perfusion, a CT-scan will be made, evaluating the effect of the procedure using the RECIST criteria. Safety and feasibility is monitored during the procedure. Overall survival, progression free survival is evaluated after the last patients has been treated.
Intervention
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 the chemosaturated blood and return the filtered blood to the patient. Six weeks after the PHP procedure, the response rate will be determined by a CT-scan, using the RECIST 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
- Biological age <18 and >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
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3947 |
| NTR-old | NTR4112 |
| CCMO | NL45988.058.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON44964 |