Primary objective • To determine the overall response rate of two PHP with an at least 6 week interval and 3 mg/kg melphalan in irresectable liver metastases patients. • To determine the percentage of patients qualifying for resection. Secondary…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Response rate expressed by RECIST criteria, after two percutaneous liver
perfusions with melphalan and an at least six week interval
• Number of curative resections after percutaneous perfusion
Secondary outcome
• Safety of percutaneous liver perfusions with the Delcath 2nd generation
system
• Overall survival and overall progression free survival
• Duration of response and duration of stable disease
• Quality of life
Background summary
Isolated therapy of the liver has the advantage of treating livermetastases,
while symptoms and side effects are limited.
The aim of this phase II trial is to show the effectivity and safety of
percutaneous isolated hepatic perfusion in treating patients with unresectable
livermetastases. Uveal melanoma disseminates hematogenously, with a high
propensity for liver, which is typical and most common site of metastasizing,
followed by lung and bones. In a majority of patients with hepatic lesions,
this is the only site of metastases.
Study objective
Primary objective
• To determine the overall response rate of two PHP with an at least 6 week
interval and 3 mg/kg melphalan in irresectable liver metastases patients.
• To determine the percentage of patients qualifying for resection.
Secondary Objective
• To assess safety of PHP using the Generation 2nd Delcath system in patients
with irresectable liver metastases.
• To determine the overall survival and overall progression free survival
• To determine the duration of response and duration of stable disease
• To determine the quality of life after two percutaneous liver perfusions.
Study design
A phase II two center trial performing a percutaneous hepatic perfusion in
patients with irresectable liver metastases of uveal melanoma.
Intervention
When all inclusion and exclusion criteria are met, a percutaneous hepatic
perfusion will be performed twice, with an at least 6 week interval between the
first and the second procedure. The perfusion procedure is extensively
described in the protocol.
Study burden and risks
Instead of systemic chemotherapeutics, the patients receives isolated hepatic
perfusion twice, and one angiography. This treamtent constists of less day
admited in hospital, and no systemic effect of chemotherapeutics.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
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)
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL45988.058.13 |
| OMON | NL-OMON21170 |