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


- candidate number15257
- NTR NumberNTR4112
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-aug-2013
- Secondary IDsNL45988.058.13. 
- Public TitlePhase II trial with melphalan for percutaneous chemosaturation (CS-PHP-Mephalan) in treating unresectable liver metastases of uveal melanoma
- Scientific TitleCS-PHP- Melfalan Uveal
- ACRONYM
- hypothesisIsolated 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.
- Healt Condition(s) or Problem(s) studiedMetastatic liver tumors, Melanoma
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 15-sep-2013
- planned closingdate15-sep-2014
- Target number of participants20
- InterventionsPercutaneous 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.
- 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
- Timepoints6 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.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD PhD A.L. Vahrmeijer
- CONTACT for SCIENTIFIC QUERIESMD PhD A.L. Vahrmeijer
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Delcath
- PublicationsN/A
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD8-aug-2013 - 28-aug-2013


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