CURRENT TRIALS

Delcath Systems Inc.

Overview of Phase III Trial:




STUDY DESIGN

o A randomized phase III multi-center trial enrolling patients with unresectable metastatic ocular or cutaneous melanoma exclusively or predominantly in the liver. Patients will be randomly assigned to receive treatments with Melphalan infused into the hepatic artery over 30 minutes via the Delcath System with filtration of the outflow from the hepatic vein through an extra-corporeal circuit or to a control group providing best alternative care ranging from palliative therapy to regional or systemic therapies with standard or investigational modalities. Patients assigned to the Delcath System may receive up to 6 cycles of treatment at approximately 4 week intervals.
o Patients randomized to the non-PHP arm are permitted to cross-over into the Delcath arm at documentation of hepatic disease progression.
o 46 patients will be enrolled per arm.


OBJECTIVES OF THE STUDY

Primary Objective:

o To determine the hepatic progression free survival of patients with melanoma (ocular or cutaneous) metastatic to liver treated with percutaneous hepatic perfusion of Melphalan with subsequent venous hemofiltration (PHP) using the Delcath system versus best alternative therapy.
o For the analysis of the primary variable progression free survival of hepatic melanoma (HPFS), 46 patients per treatment arm has 80% power to detect an approximate median difference of 4 months under the assumption that the median time of HPFS is 4 months for the patients randomized to Best Alternative Care and 7.73 months for those randomized to the Delcath System.

Secondary Objectives:

o To determine the response rate to PHP in patients with cutaneous and ocular melanoma metastatic to liver.
o To determine the duration of response and the patterns of recurrence of patients treated with PHP for metastatic melanoma.
o To determine the overall survival in patients with hepatic metastases following treatment with standard treatments and after treatment with the Delcath system.

ELIGIBILITY CRITERIA

o Male or female patients at least 18 years of age with a life expectancy of at least 3 months
o Histologically or cytologically proven cancer, predominantly in the parenchyma of the liver from cutaneous or ocular melanoma histologies.
o Patients must have had no chemotherapy, radiotherapy, or biologic therapy for their malignancy in the month prior to treatment and the patient must have recovered from all side effects of previous therapeutic and diagnostic interventions.
o Patients must have an ECOG performance standard of < 3.
o Patients must have adequate hepatic function as evidence by a total serum bilirubin < 3.0 mg/dL and a PT within 2 seconds of the upper normal limit. AST/ALT must be ≤ 10 times upper limit of normal.

NCI TRIAL LISTING

> http://clinicaltrials.gov/ct/show/NCT00324727?order=4

UNIVERSITY OF MARYLAND LISTING

>http://data.umms.org/scripts/trials/listing.cfm?doctor=Richard+Alexander%2C+M.D.&x=4&y=8

For any questions, please contact
Delcath Systems, Inc.
Rockefeller Center
600 Fifth Avenue, 23rd Floor
New York, NY 10020
Telephone: (212) 489-2100
Fax: (212) 489-2102