Phase 2 Clinical Trial

Background

Treatment of patients with tumors in the liver with melphalan: hepatocellular carcinoma (primary liver cancer), metastatic adenocarcinomas, and neuroendocrine tumors in the liver and patients with metastatic ocular and cutaneous melanoma who received prior regional melphalan therapy; study taking place at the National Cancer Institute.

Study Design

  • A phase 2 trial in which 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 extracorporeal circuit.
  • Patients will be stratified for entry based on histology. This study will include four cohorts of patients with the following cancers: neuroendocrine tumors, hepatocellular carcinoma, ocular or cutaneous melanoma, and metastatic adenocarcinoma.

Objectives of the Study

Primary Objective:

  • To determine the response rate and duration of response to intrahepatic infusion of melphalan with subsequent venous hemofiltration.
  • This trial will be conducted using a 4-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:

  • To determine the patterns of recurrence in patients following this therapy.
  • To determine the disease-free and overall survival in patients following this therapy.

NCI Trial Listing

http://clinicaltrials.gov/ct/show/NCT00096083?order=3



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Delcath does not make any claim whatsoever, real or implied, about the efficacy or safety of any therapy, drug, system, or technique under active research.