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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Study of Intrahepatic Arterial Infusion of Melphalan With Venous Filtration Via Peripheral Hepatic Perfusion in Patients With Unresectable Primary or Metastatic Liver Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 16 and over NCI NCI-04-C-0273 NCI-6332, DELCATH-G990039, NCT00096083

Special Category: NIH Clinical Center trial

Trial Description

Purpose:

Hepatic arterial infusion uses a catheter to deliver anticancer substances directly into the liver. Drugs used in chemotherapy, such as melphalan, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells.

This phase II trial is studying how well giving an hepatic arterial infusion of melphalan together with hepatic perfusion works in treating patients with unresectable liver cancer.

Eligibility:

Eligibility criteria include the following:

• At least 16 years old
• More than 1 month since biological therapy, chemotherapy, or radiation therapy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will have catheters placed via the groin into an artery leading to the liver and into a vein leading away from the liver to isolate the liver's blood supply from the rest of the body. They will then receive an infusion of melphalan into the hepatic artery. Treatment may be repeated approximately every 3-8 weeks for up to six infusions. Patients will be evaluated every 3 months for 2 years, every 4 months for 1 year, and periodically thereafter.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Marybeth Hughes, MD, Principal investigator		Ph: 301-594-9341

U.S.A.
Maryland
	Bethesda
	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
		Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office	Ph:  888-NCI-1937

Registry Information
Official Title		A Phase II Study Of Hepatic Arterial Infusion Of Melphalan With Venous Filtration Via Peripheral Hepatic Perfusion (PHP) For Unresectable Primary And Metastatic Cancers Of The Liver
Trial Start Date		2004-09-15
Registered in ClinicalTrials.gov		NCT00096083
Date Submitted to PDQ		2004-09-15
Information Last Verified		2008-11-30