<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01728051</url>
  </required_header>
  <id_info>
    <org_study_id>MEL 2009-01</org_study_id>
    <nct_id>NCT01728051</nct_id>
  </id_info>
  <brief_title>Expanded Access Study of Melphalan With Delcath CS-PHP System in Patients With Ocular/Cutaneous Melanoma Mets to Liver</brief_title>
  <official_title>An Open Label, Expanded Access Study of Melphalan Chemosaturation With the Delcath System in Patients With Ocular and Cutaneous Melanoma Metastatic to the Liver</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Delcath Systems Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Delcath Systems Inc.</source>
  <brief_summary>
    <textblock>
      The safety and efficacy of CS-PHP-melphalan has been evaluated in a phase 3 trial conducted&#xD;
      in the same patient population as well as using the same melphalan dosing as proposed in this&#xD;
      study. This expanded access protocol will provide an experimental alternative treatment&#xD;
      option for both physicians and patients until the Delcath CS-PHP System receives marketing&#xD;
      approval.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>No longer available</overall_status>
  <study_type>Expanded Access</study_type>
  <condition>Metastatic Liver Cancer</condition>
  <condition>Ocular Melanoma</condition>
  <condition>Cutaneous Melanoma</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Melphalan</intervention_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Percutaneous Hepatic Perfusion</intervention_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically proven ocular/cutaneous melanoma with liver-dominant unresectable&#xD;
             metastatic disease, defined as limited extra-hepatic disease and hepatic involvement&#xD;
             which would, in the Investigator's opinion, result in morbidity and eventual&#xD;
             mortality. Limited extra-hepatic disease considered acceptable includes:&#xD;
&#xD;
               -  up to 4 pulmonary nodules, each &lt;1cm in diameter&#xD;
&#xD;
               -  retroperitoneal lymph nodes &lt;1cm in diameter&#xD;
&#xD;
               -  resectable skin or subcutaneous metastases&#xD;
&#xD;
               -  asymptomatic bone metastases that have been, or can be, palliated with external&#xD;
                  beam radiation therapy&#xD;
&#xD;
               -  a solitary metastasis to any site that can be resected with limited morbidity or&#xD;
                  controlled with radiation&#xD;
&#xD;
          2. ≥1 measurable hepatic lesion per RECIST 1.1&#xD;
&#xD;
          3. Vasculature compatible with insertion of CS-PHP catheters, per baseline abdominal MRA&#xD;
&#xD;
          4. ECOG PS 0-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Chemotherapy, radiotherapy, or biologic therapy for the malignancy ≤1 month prior to&#xD;
             1st CS-PHP-melphalan infusion&#xD;
&#xD;
          2. Extensive prior radiotherapy, defined as treatment to ≥50% of marrow-containing bones&#xD;
&#xD;
          3. Immunosuppressive drugs such as cyclosporine, tacrolimus, azathioprine, or long-term&#xD;
             oral glucocorticoids taken currently or ≤3 mths prior to 1st CS-PHP-melphalan infusion&#xD;
&#xD;
          4. Received an investigational product ≤30 days prior to the 1st CS-PHP-melphalan&#xD;
             infusion&#xD;
&#xD;
          5. History of orthotopic liver transplantation, untreated gastrinoma (i.e. gastric acid&#xD;
             hypersecretion) or prior Whipple procedure&#xD;
&#xD;
          6. Not recovered from side effects of prior therapy to ≤ Grade 1 NCI CTCAE 4.03&#xD;
&#xD;
          7. Child's B or C cirrhosis, or clinical evidence of portal hypertension&#xD;
&#xD;
          8. Patients with &gt;50% of liver replaced by tumor, histologic evidence of hepatic&#xD;
             dysfunction seen by laparoscopic liver biopsy&#xD;
&#xD;
          9. History or evidence of clinically significant cardiac disease such as symptomatic&#xD;
             arrhythmia, angina/ischemia, coronary artery bypass graft surgery or percutaneous&#xD;
             transluminal coronary angioplasty, uncontrolled atrial fibrillation, CHF with a left&#xD;
             ventricular ejection fraction &lt;40%, uncontrolled hypertension (SBP &gt;190 mmHg or DBP&#xD;
             &gt;100 mmHg), HR outside normal range of 50-100 bpm for women and 45-100 bpm for men&#xD;
&#xD;
         10. History/evidence of clinically significant pulmonary or cardiac disease incompatible&#xD;
             with fitness to undergo general anesthesia&#xD;
&#xD;
         11. Uncontrolled diabetes mellitus or hypo/hyperthyroidism&#xD;
&#xD;
         12. Active uncontrolled infection&#xD;
&#xD;
         13. History of bleeding disorders or known unresolved venous shunting&#xD;
&#xD;
         14. Requirement for ongoing chronic anticoagulation&#xD;
&#xD;
         15. Evidence of intracranial abnormalities resulting in risk for bleeding with&#xD;
             anticoagulation&#xD;
&#xD;
         16. History of alcohol or drug abuse ≤6 mths&#xD;
&#xD;
         17. Other malignancy within 3 yrs before enrollment with the exception of curatively&#xD;
             treated basal or squamous cell carcinoma of the skin, or curatively treated cervical,&#xD;
             breast carcinoma in situ or prostate cancer&#xD;
&#xD;
         18. History of hypersensitivity to: melphalan or its components; iodine contrast that&#xD;
             cannot be controlled by premedication with antihistamines and steroids; latex&#xD;
&#xD;
         19. Known hypersensitivity to heparin in the presence of heparin-induced thrombocytopenia&#xD;
             antibodies&#xD;
&#xD;
         20. Inadequate hematological or renal function as indicated by any of the following:&#xD;
&#xD;
               -  Platelets &lt;100,000/mm3&#xD;
&#xD;
               -  Hb ≤10 g/dL&#xD;
&#xD;
               -  Neutrophils &lt;2,000/mm3&#xD;
&#xD;
               -  S Creat &gt;1.5 mg/dL or measured creatinine clearance &lt;60 mL/min/1.73 m2&#xD;
&#xD;
         21. Inadequate liver function as indicated by any of the following:&#xD;
&#xD;
               -  Tbili ≥3.0 mg/dL&#xD;
&#xD;
               -  INR &gt;1.5&#xD;
&#xD;
               -  AST/ALT &gt;5xULN&#xD;
&#xD;
         22. Pregnant or nursing&#xD;
&#xD;
         23. Positive pregnancy test in subjects of childbearing potential ≤7 days prior to first&#xD;
             CS-PHP-melphalan infusion&#xD;
&#xD;
         24. Women who are pre-menopausal (i.e. have had a menstrual period ≤12 months) who are&#xD;
             unwilling or unable to undergo hormonal suppression to avoid menstruation during&#xD;
             treatment&#xD;
&#xD;
         25. Sexually active females of childbearing potential and sexually active males with&#xD;
             partners of reproductive potential unwilling or unable to use contraception from&#xD;
             screening until at least 30 days after last administration of CS-PHP-melphalan&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Charles W Nutting, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sky Ridge Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jonathan Zager, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>H. Lee Moffitt Cancer Center and Research Institue at University of Southern Florida</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mark Faries, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint John's Cancer Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>James F Pingpank, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Univeristy of Pittsburg Cancer Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eric D Whitman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Carol G. Simon Cancer Center at Morristown Memorial Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>H. Richard Alexander, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Maryland Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>John Wayne Cancer Institute at Saint John's Health Center</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sky Ridge Medical Center</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Lee Moffitt Cancer Center and Research Institute at University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612-9497</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carol G. Simon Cancer Center at Morristown Memorial Hospital</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07962-1956</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburg Cancer Institute</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.delcath.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2013</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>October 22, 2013</last_update_submitted>
  <last_update_submitted_qc>October 22, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 23, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
    <mesh_term>Skin Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melphalan</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01728051
org study id: MEL 2009-01
nct id: NCT01728051
lead sponsor: 
The safety and efficacy of CS-PHP-melphalan has been evaluated in a phase 3 trial conducted
      in the same patient population as well as using the same melphalan dosing as proposed in this
      study. This expanded access protocol will provide an experimental alternative treatment
      option for both physicians and patients until the Delcath CS-PHP System receives marketing
      approval.
intervention type: Drug
intervention name: Melphalan
intervention type: Device
intervention name: Percutaneous Hepatic Perfusion
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Charles W Nutting, DO
role: Principal Investigator
affiliation: Sky Ridge Medical Center
last name: Jonathan Zager, MD
role: Principal Investigator
affiliation: H. Lee Moffitt Cancer Center and Research Institue at University of Southern Florida
last name: Mark Faries, MD
role: Principal Investigator
affiliation: Saint John's Cancer Institute
last name: James F Pingpank, MD
role: Principal Investigator
affiliation: Univeristy of Pittsburg Cancer Center
last name: Eric D Whitman, MD
role: Principal Investigator
affiliation: Carol G. Simon Cancer Center at Morristown Memorial Hospital
last name: H. Richard Alexander, MD
role: Principal Investigator
affiliation: University of Maryland Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.delcath.com
description: Related Info
responsible party type: Sponsor
mesh term: Melanoma
mesh term: Skin Neoplasms
mesh term: Melphalan