Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma
Research type
Research Study
Full title
A Randomized, Controlled, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients with Hepatic-Dominant Ocular Melanoma.
IRAS ID
195573
Contact name
Christian Ottensmeier
Contact email
Sponsor organisation
Delcath Systems, Inc
Eudract number
2015-000417-44
Duration of Study in the UK
3 years, 5 months, 17 days
Research summary
Ocular melanoma is rare cancer of the eye with about 900 new cases diagnosed annually in the UK. About 50% of patients develop metastatic disease, and in the majority patients metastases involve the liver. No effective systemic treatment for this condition exists, and none have so far to altered the natural history of the disease. Where local treatment such as surgery or ablation is not possible due to either size or number of deposits, the growth of the hepatic metastases determines the survival of the patient. The poor prognosis associated with hepatic metastasis from ocular melanoma has led to the development of regional liver directed treatment strategies. These approaches have the potential to provide control of the life-threatening liver disease, with little toxicity outside of the liver. This study will therefore recruit patients with metastatic uveal melanoma, which only or predominantly affects the liver. Percutaneous hepatic perfusion (PHP) was developed as a minimally invasive alternative to previous therapies.
Melphalan hydrochloride for injection for use with the Melphalan Hepatic Delivery System (Melphalan/HDS) is a device which is CE marked in the EU (CHEMOSAT®). During treatment a dose of melphalan hydrochloride chemotherapy is given intra arterially to the liver. At the same the hepatic venous blood is passed through and extra - corporeal filter. This removes melphalan from the blood before it is returned to the systemic circulation. This greatly reduces the amount of chemotherapy exposure in the rest of the patient’s body.
The Melphalan/HDS treatment does not interrupt blood supply to the healthy liver. Melphalan HDS additionally has the advantage over other methods of intrahepatic treatment: it treats the whole liver and therefore microscopic cancer as well as tumors, which are visible on scans. The relatively non-invasive nature of Melphalan/HDS also allows it to be repeated and multiple treatments can be given serially.
Please refer to pages 43-45 of the protocol version 2.0 dated 04 November 2015 for the full inclusion and exclusion criteria.The interventional part of the study will last for 3 years. Long term follow up for survival is planned for all enrolled
patients. All patients will attend an end of treatment visit 6 to 8 weeks following the final administration of study
treatment. Patients will be contacted by phone every 6 months for survival status for the first two years, then yearly thereafter, until death, withdrawal of informed consent or loss to follow up, whichever occurs first.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
16/SC/0071
Date of REC Opinion
31 Mar 2016
REC opinion
Further Information Favourable Opinion