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

Alternate Title

Phase III Randomized Study of Percutaneous Isolated Hepatic Arterial Perfusion With Melphalan With Subsequent Venous Hemofiltration Versus Best Alternative Standard Treatment in Patients With Unresectable Liver Metastases Secondary to Ocular or Cutaneous Melanoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 and over NCI NCI-06-C-0088 NCI-P6701, NCT00324727

Special Category: NCI Web site featured trial, NIH Clinical Center trial

Trial Description

Purpose:

Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving melphalan directly into the arteries around the tumor may kill more tumor cells. It is not yet known whether hepatic arterial infusion with melphalan is more effective than standard therapy in treating liver metastases due to melanoma.

This randomized phase III trial is studying hepatic arterial infusion with melphalan to see how well it works compared to standard therapy in treating patients with unresectable liver metastases due to melanoma.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable disease
• At least 1 month since chemotherapy, radiation therapy, or biological therapy for this cancer
• No previous Whipple procedure
• 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 be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will undergo isolated hepatic infusion with melphalan. Treatment may repeat every 4 weeks for up to six courses.

Patients in group two will receive standard therapy chosen by their doctor.

Patients will undergo blood sample collection periodically for laboratory studies.

After finishing treatment, patients will be evaluated periodically for 4 years and once a year 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.
California
	Santa Monica
	John Wayne Cancer Institute at Saint John's Health Center
		Clinical Trials Office - John Wayne Cancer Institute	Ph:  310-582-7427
Colorado
	Englewood
	Swedish Medical Center
		Charles Nutting, DO	Ph:  303-788-5000
Florida
	Tampa
	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
		Clinical Trials Office - H. Lee Moffitt Cancer Center and Reseach Institute	Ph:  800-456-7121
			Email: canceranswers@moffitt.org
Maryland
	Baltimore
	Greenebaum Cancer Center at University of Maryland Medical Center
		Clinical Trials Office - Greenebaum Cancer Center at University of Maryladn Medical Center	Ph:  800-888-8823
	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
New Jersey
	Morristown
	Carol G. Simon Cancer Center at Morristown Memorial Hospital
		Eric Whitman, MD	Ph:  973-429-6747 800-247-9580
			Email: eric.whitman@ahsys.org
New York
	Albany
	Cancer Center of Albany Medical Center
		Clinical Trials Office - Cancer Center of Albany Medical Center	Ph:  518-262-5182
Pennsylvania
	Bethlehem
	St. Luke's Cancer Network at St. Luke's Hospital
		Sanjiv Agarwala, MD	Ph:  610-954-2145
	Pittsburgh
	UPMC Cancer Centers
		Clinical Trials Office - UPMC Cancer Centers	Ph:  412-647-8073
Texas
	Galveston
	University of Texas Medical Branch
		Clinical Trials Office - University of Texas Medical Branch	Ph:  409-772-1950

Related Information

Featured trial article

Registry Information
Official Title		A Random-Assignment Study of Hepatic Arterial Infusion of Melphalan with Venous Filtration Via Peripheral Hepatic Perfusion (PHP) (Delcath System) Versus Best Alternative Care for Ocular and Cutaneous Melanoma Metastatic to the Liver
Trial Start Date		2006-02-13
Registered in ClinicalTrials.gov		NCT00324727
Date Submitted to PDQ		2006-02-13
Information Last Verified		2008-10-01