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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00324727 |
RATIONALE: 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.
PURPOSE: 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.
Condition | Intervention | Phase |
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Intraocular Melanoma Melanoma (Skin) Metastatic Cancer |
Drug: melphalan Drug: regional chemotherapy Drug: systemic chemotherapy Procedure: hepatic artery embolization |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
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 |
Estimated Enrollment: | 92 |
Study Start Date: | February 2006 |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients undergo an isolated hepatic arterial infusion of melphalan over 30 minutes on day 1. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response undergo 2 additional courses in the absence of ongoing or increasing toxicity. |
Drug: melphalan
Given throug isolated hepatic artery infusion
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Arm II: Active Comparator
Patients receive the best alternative therapy comprising supportive care, systemic or regional chemotherapy, hepatic artery (chemo)-embolization, or any other appropriate therapy at the National Cancer Institute or therapy at the discretion of their physician. Patients may cross over to arm I if they have evidence of disease progression. |
Drug: regional chemotherapy
Patients receive the best alternative therapy
Drug: systemic chemotherapy
Patients receive the best alternative therapy
Procedure: hepatic artery embolization
Patients receive the best alternative therapy
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, open-label, comparative study. Patients are stratified according to site of disease (ocular vs cutaneous). Patients are randomized to 1 of 2 treatment arms.
Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients with complete or partial response undergo 2 additional courses in the absence of ongoing or increasing toxicity.
After completion of study treatment, patients are followed periodically for 4 years and then annually for survival.
PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed liver metastases secondary to cutaneous or ocular melanoma
Limited unresectable extrahepatic disease allowed provided the life-limiting component of progressive disease is in the liver, including, but not limited to, any of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
John Wayne Cancer Institute at Saint John's Health Center | Recruiting |
Santa Monica, California, United States, 90404 | |
Contact: Clinical Trials Office - John Wayne Cancer Institute 310-582-7427 | |
United States, Colorado | |
Swedish Medical Center | Recruiting |
Englewood, Colorado, United States, 80113 | |
Contact: Charles Nutting, DO 303-788-5000 | |
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Recruiting |
Tampa, Florida, United States, 33612-9497 | |
Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese 800-456-7121 canceranswers@moffitt.org | |
United States, Maryland | |
Greenebaum Cancer Center at University of Maryland Medical Center | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit 800-888-8823 | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |
United States, New Jersey | |
Carol G. Simon Cancer Center at Morristown Memorial Hospital | Recruiting |
Morristown, New Jersey, United States, 07962-1956 | |
Contact: Eric D. Whitman, MD 973-429-6747 eric.whitman@ahsys.org | |
United States, New York | |
Cancer Center of Albany Medical Center | Recruiting |
Albany, New York, United States, 12208 | |
Contact: Clinical Trials Office - Cancer Center of Albany Medical Cente 518-262-5182 | |
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting |
Columbus, Ohio, United States, 43210-1240 | |
Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 osu@emergingmed.com | |
United States, Oregon | |
Providence Cancer Center at Providence Portland Medical Center | Recruiting |
Portland, Oregon, United States, 97213-2967 | |
Contact: Clinical Trials Office - Providence Cancer Center at Providenc 503-215-6412 | |
United States, Pennsylvania | |
St. Luke's Cancer Network at St. Luke's Hospital | Recruiting |
Bethlehem, Pennsylvania, United States, 18015 | |
Contact: Sanjiv S. Agarwala, MD 610-954-2145 | |
UPMC Cancer Centers | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073 | |
United States, Texas | |
University of Texas Medical Branch | Recruiting |
Galveston, Texas, United States, 77555-0361 | |
Contact: Clinical Trials Office - University of Texas Medical Branch 409-772-1950 |
Principal Investigator: | Marybeth S. Hughes, MD | NCI - Surgery Branch |
Study ID Numbers: | CDR0000468944, NCI-06-C-0088, NCI-P6701 |
Study First Received: | May 10, 2006 |
Last Updated: | July 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00324727 History of Changes |
Health Authority: | Unspecified |
liver metastases extraocular extension melanoma stage IV melanoma recurrent melanoma |
recurrent intraocular melanoma metastatic intraocular melanoma iris melanoma ciliary body and choroid melanoma, medium/large size |
Melphalan Immunologic Factors Eye Neoplasms Uveal Melanoma Eye Diseases Melanoma of the Choroid Immunosuppressive Agents Recurrence Melanoma Neuroendocrine Tumors |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neoplasm Metastasis Intraocular Melanoma Neuroepithelioma Antineoplastic Agents, Alkylating Nevus Alkylating Agents Melanoma, Familial |
Melphalan Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Melanoma Neoplastic Processes Neoplasms by Site Pathologic Processes Neoplasms, Germ Cell and Embryonal Therapeutic Uses Neoplasm Metastasis |
Nevi and Melanomas Alkylating Agents Neoplasms by Histologic Type Eye Neoplasms Eye Diseases Immunosuppressive Agents Pharmacologic Actions Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating |