FOR PHYSICIANS
Current Trials: Phase II
STUDY DESIGN
o A phase II trial in Patients with unresectable cancers confined to the liver
will 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
o Patients will be stratified for entry based on histology. This will include
4 cohorts of patients: neuroendocrine tumors, hepatocellular carcinoma, ocular
or cutaneous melanoma, and metastatic adenocarcinoma.
o A maximum of 100-105 patients
OBJECTIVES OF THE STUDY
Primary Objective:
o To determine the response rate and duration of response to intra-hepatic
infusion of melphalan with subsequent venous hemofiltration.
o This trial will be conducted using a four arm, Simon optimal phase II design
for each arm. The arms will be: neuroendocrine tumors, adenocarcinoma, hepatocellular
carcinoma, ocular and cutaneous melanoma (patients must have received prior
regional melphalan therapy). For each arm, the objective will be to identify
if a reasonably high 45% response probability (p1=0.45) may be identified
as opposed to an undesirably low 20% probability (p0=0.20).
Secondary Objectives:
o To determine the patterns of recurrence in patients following this therapy.
o To determine the disease-free and overall survival in patients following
this therapy.
ELIGIBILITY CRITERIA
o Male or female patients at least 16 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 with one of the following histologies: adenocarcinoma, neuroendocrine
tumor or primary hepatic malignancy. Patients with hepatic metastases from
colorectal tumors are allowed if patients have been treated with first and
second line chemotherapy including irenotecan and oxaliplatin.
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/NCT00096083?order=3
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
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