Last updated on September 2018

Percutaneous Hepatic Perfusion in Patients With Hepatic-dominant Ocular Melanoma

Brief description of study

This study will evaluate patients who have melanoma that has spread from the eye to the liver: Patients in the study will be treated with Melphalan/HDS up to 6 total treatment, and will be followed until death. This study will evaluate the safety and effects of the treatment 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 the eligibility date to determine each patient's overall eligibility and baseline characteristics. 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, Quality of Life questionnaire, radiologic assessments of baseline disease status and concomitant medications.

For patients with a history of liver surgery or major vasculature surgery, an angiogram evaluation of their vasculature will be performed for compatibility for Percutaneous Hepatic Perfusion (PHP) prior to confirming eligibility.

Eligibility date: This is the date on which all screening assessments have been completed and the patient is determined to be eligible for the trial.

Treatment Phase: Eligible patients will be treated with Melphalan/HDS 3.0 mg/kg Ideal Body Weight (IBW) and must begin treatment within 14 days being eligible. 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 every 12 weeks (+ 2 weeks) until 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 progressive disease (PD) is observed, the patient will be removed from further study treatment and followed until death. 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 study treatment. Ongoing treatment related adverse events (AEs) at the end-of-treatment visit will be followed until the severity is within one of the following parameters (1) Symptoms are resolved or return to baseline; (2) CTCAE Grade < 1 or can be explained; (3) patient death. The maximum possible duration of the study treatment for any patient will be 12 months.

NOTE: Active Melphalan/HDS patients (currently in treatment) on PHP-OCM-301 will continue treatment on PHP-OCM-301A following the re-consenting process.

NOTE: Patients on PHP-OCM-301 that have completed treatment and are entering or are already in the follow-up phase will be followed-up for survival and disease progression (as applicable) on PHP-OCM-301A following the re-consenting process.

Follow-up Phase: Once the patient has completed the end-of-treatment (EOT) visit in accordance with the schedule of events they will enter the follow-up phase. If the disease has not progressed at the EOT (Section 6.2), the patient will need to continue with disease assessment visits every 12 weeks (+ 2 weeks) until disease progression is documented. If the disease has progressed before or at the EOT their follow-up is to be by phone every 3 months for survival status until death.

Patients will be monitored, 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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Tara Turner

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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Tara Turner

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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Tara Turner

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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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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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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Anja Gesierich, Dr. med.

Universit tsklinikum W rzburg
Würzburg, Germany
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Reinhard Dummer, Prof. Dr.

Universit tsSpital Z rich
Zürich, Switzerland
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Recruitment Status: Open

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