Phase II trial with melphalan for percutaneous chemosaturation (CS-PHP-Mephalan) in treating unresectable liver metastases of uveal melanoma

Phase 2

Completed

Conditions: livermetastases
livermetastases of uveal melanoma
10019815

Registration Number: NL-OMON44964

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 34

Inclusion Criteria

• Informed consent
• Liver metastases of histologically confirmed primary uveal melanoma
• When resection of primary tumor, this has to be > 1 month before PHP and having fully recovered from surgery
• Unresectable metastases metastases confined to the liver based on CT-Thorax/abdomen and PET imaging
• Metastases measurable on CT-scan
• Life expectancy > 4 months
• APTT < 32.5 sec (<= 1.5 times ULN if considered due to tumor)
• PT < 13.7 sec (<= 1.5 times ULN if considered due to tumor)

Exclusion Criteria

• Biological age <18 and >75 years
• WHO performance status >= 2 (Appendix A)
• < 40% healthy liver tissue
• Aberrant vascular anatomy or vascular abnormalities (e.g. severe atherosclerosis, vascular dissections), which impede PHP
• 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
• Intracranial lesions with a propensity to bleed (on Brain CT or MRI)
• LDH (> 2 times ULN)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Response rate expressed by RECIST criteria, after two percutaneous liver<br /><br>perfusions with melphalan and an at least six week interval<br /><br>• Number of curative resections after percutaneous perfusion</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Safety of percutaneous liver perfusions with the Delcath 2nd generation<br /><br>system<br /><br>• Overall survival and overall progression free survival<br /><br>• Duration of response and duration of stable disease<br /><br>• Quality of life</p><br>