Last updated on February 2018

Percutaneous Hepatic Perfusion vs Best Alternative Care in Patients With Hepatic-dominant Ocular Melanoma

Brief description of study

This study will evaluate two groups of patients who have melanoma that has spread from the eye to the liver: one group (50%) will get high-dose chemotherapy delivered specifically to the liver, while the other group (50%) will get one of 4 standard best alternative care treatments. Patients in each group will get repeating cycles of treatment until the cancer in the liver advances and will be followed until death. This study will evaluate the effect of the treatments on how long patients live and how long it takes for the cancer to advance or respond to the treatment.

Detailed Study Description

The study will consist of 3 phases: a screening phase, treatment phase, and follow-up phase.

Screening Phase: Screening assessments will be conducted within 28 days prior to randomization to determine each patient's overall eligibility. These assessments will include medical history, physical examination, Eastern Cooperative Oncology Group (ECOG) performance status (PS), 12 lead electrocardiogram (ECG), echocardiogram (ECHO), vital signs, full hematology and biochemistry, radiologic assessments of disease status, and an evaluation of the vasculature compatibility for Percutaneous Hepatic Perfusion (PHP).

Treatment Phase: Eligible patients will be randomized to treatment with Melphalan/HDS 3.0 mg/kg Ideal Body Weight (IBW) or Best Alternative Care (BAC) and must begin treatment within 14 days following randomization. BAC treatment will be: dacarbazine (DTIC); transarterial chemoembolization (TACE); ipilimumab; or pembrolizumab, based on each institution's rank order of their BAC treatments based on their standard of care (SOC). For Melphalan/HDS treatment, patients will receive up to 6 treatments. Each treatment cycle consists of 6 weeks with an acceptable delay for another 2 weeks before the next planned treatment to allow for recovery of melphalan-related toxicity, if needed. Tumor response will be assessed in both cohorts every 12 weeks (+ 2 weeks) until hepatic disease progression. If the patient receives only 1 treatment, the disease assessment scans will be conducted 12 weeks after the date of the first treatment. The assessment scans will be reviewed by an Independent Review Committee (IRC), also referred to as Independent Central Review. At any time when hepatic progressive disease (PD) is observed, the patient will be removed from further study treatment. Melphalan/HDS treatment will also be discontinued in the event that recovery from treatment related toxicity requires more than 8 weeks from last treatment. An end-of-treatment visit will be conducted approximately 6 to 8 weeks following the final dose of study treatment. Ongoing adverse events (AEs) at the end-of-treatment visit will be followed until the severity returns to baseline of CTCAE Grade < 1. The maximum possible duration of the study treatment for any patient will be 12 months.

Follow-up Phase: In the event that disease has not progressed at the end-of-treatment visit, disease assessment scans will continue every 12 weeks (+ 2 weeks) until disease progression is documented. Patients will be contacted by phone every 6 months for survival status for the first two years following the completion of study treatment, then yearly thereafter, until death, withdrawal of informed consent or they become lost to follow-up, whichever occurs first. Patients will be monitored for two years, following the completion of study treatment, for the development of myelodysplasia and secondary leukemia.

Clinical Study Identifier: NCT02678572

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Sunil Reddy, MD

Stanford University
Palo Alto, CA United States
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Jonathan Zager, MD

Moffitt Cancer Center
Tampa, FL United States
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Melinda Yushak, MD

Emory University
Atlanta, GA United States
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Jason Luke, MD

University of Chicago
Chicago, IL United States
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Leslie Callahan, RN

University of Maryland Cancer Center
Baltimore, MD United States
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Eric Whitman, MD

Atlantic Melanoma Center at Morristown Medical Center
Morristown, NJ United States
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Boris Kuvshinoff II, MD

Roswell Park Cancer Institute
Buffalo, NY United States
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Georgia Beasley, MD

Duke University Medical Center
Durham, NC United States
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John Harrison Howard, MD

Ohio State University James Cancer Center
Columbus, OH United States
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Sanjiv Agarwala, MD

St. Luke's University Hospital Cancer Center
Bethlehem, PA United States
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Marlana Orloff, MD

Thomas Jefferson University
Philadelphia, PA United States
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Evan Glazer, MD

University of Tennessee Health Science Center
Memphis, TN United States
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Leslie Callahan, RN

MD Anderson Cancer Center
Houston, TX United States
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Erika Richtig, Dr. med

Universit tsklinikum Graz
Graz, Austria
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Pol Specenier, Prof. Dr.

Universitair Ziekenhuis Antwerp
Antwerp, Belgium
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Vibeke Kruse, Dr.

Universitair Ziekenhuis Gent
Gent, Belgium
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Geert Maleux, Prof. Dr.

Universitair Ziekenhuis Leuven
Leuven, Belgium
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Michel Rivoire, Prof.

Centre L on B rard
Lyon, France
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Sophie Piperno-Neumann, Dr.

Institut Curie
Paris, France
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Sebastian Ochsenreither, Dr. med.

Charit Unversit tsmedizin Berlin Comprehensive Cancer Center
Berlin, Germany
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Leslie Callahan, RN

Universit tsklinikum Magdeburg
Magdeburg, Germany
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Armin Bender, Dr. med.

Universit tsklinikum Giessen und Marburg
Marburg, Germany
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Sebastian Haferkamp, Dr. med

Universit tsklinikum Regensburg
Regensburg, Germany
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Anja Gesierich, Dr. med.

Universit tsklinikum W rzburg
Würzburg, Germany
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Pier Francesco Ferrucci

Istituto Europeo di Oncologia
Milan, Italy
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Salvador Martin Algarra, Dr.

Cl nica Universidad de Navarra
Pamplona, Spain
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Ana Arance, Dra.

Cl nic Barcelona
Barcelona, Spain
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Ainara Soria Rivas, Dra.

Hospital Ram n y Cajal
Madrid, Spain
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Reinhard Dummer, Prof. Dr.

Universit tsSpital Z rich
Zürich, Switzerland
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Christian Ottensmeier, Prof.

University Hospital Southampton NHS Trust
Southampton, United Kingdom
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Michael Gonsalves, MBBS

St. George's University Hospital of London
London, United Kingdom
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