FOR PATIENTS
The Delcath System
The Delcath system, or Percutaneous Hepatic Perfusion (PHP), offers a new
regionalized approach for the treatment of unresectable hepatic malignancies
in which the drug Melphalan is administered via the hepatic artery and the
venous effluent of the liver is collected and filtered using a percutaneously
placed catheter and filtration system. Benefits of the procedure include:
Minimally invasive – PHP utilizes a series of catheters
and extracorporeal filters to infuse high doses of chemotherapeutic agents
to tumors in the liver with minimal systemic exposure.
Higher Dosing – PHP allows infusion doses exceeding
those of systemic or intra-arterial administration.
Treatment Flexibility - PHP can be performed in an operating
room or in a radiology suite under local or general anesthesia.
Repeatable Procedure - Unlike surgical isolated hepatic perfusion
(IHP), which can be performed only once, PHP can be repeated several times.
Patients within the trial usually receive the treatment at four-week intervals
and up to ten treatments have been administered to a patient.
Decreased Toxicity - Filtration of the hepatic venous effluent
can reduce systemic exposure of chemotherapy by 80% to 90% compared to hepatic
artery infusion alone.
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THE DELCATH TREATMENT:
Delcath has developed a system to mechanically isolate the liver from the
general circulatory system in order to treat cancer in the liver with high
doses of chemotherapeutic drugs while preventing the drugs from causing toxic
effects upon other tissues. The Delcath treatment is called Percutaneous Hepatic
Perfusion (PHP). PHP can be performed in an operating room or in a radiology
suite under local or general anesthesia. Patients within the trial will receive
up to six treatments, usually administered at four-week intervals.
The Delcath Approach:
Why It Works!
The Delcath approach to treatment employs a system of catheters and filters
to isolate the liver from the general circulatory system and delivers a chemotherapeutic
agent directly to the liver. The filters then remove the therapeutic agent
from the blood before the blood circulates to the body. In this manner, the
tumor is exposed to a high dose of the therapeutic, but all other regions of
the body remain protected from the toxic effects.
Clinical Results:
The Delcath system, or Percutaneous Hepatic Perfusion (PHP), has undergone
extensive testing in liver cancer patients, and is currently undergoing Phase
II and Phase III trials with the drug melphalan against a variety of cancerous
tumors in the liver. The Delcath system is not currently approved for marketing
by the United States Food and Drug Administration, and it cannot be marketed
in the United States without FDA approval. Clinical trials have demonstrated
that the use of PHP in the treatment of cancers in the liver allows significantly
higher doses of chemotherapy to be administered to the liver than can be administered
with conventional systemic chemotherapy without an increase in associated toxicities.
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Current Trials
· Phase III trial using the drug melphalan for patients with metastatic
ocular or cutaneous melanoma in the liver
· Phase II trial using the drug melphalan for patients with primary
liver cancer (hepatocellular carcinoma) and metastatic tumors in the liver
from neuroendocrine cancers and adenocarcinomas
Trial Qualifications
Patients (both male and female) over the age of 18 with primary liver cancer
or metastatic ocular melanoma, cutaneous melanoma, neuroendocrine cancer or
adenocarcinoma, who have unresectable tumors in the liver
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