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…
ID
Bron
Aandoening
livermetastases of uveal melanoma
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Objective response rate expressed as the RECIST 1.1 criteria (Appendix A)<br>
- Percentage of patients whose metastases turned into resectable ones
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3947 |
| NTR-old | NTR4112 |
| CCMO | NL45988.058.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON44964 |