Percutaneous Hepatic Perfusion in Patients With Hepatic-dominant Ocular Melanoma

Not Recruiting

Trial ID: NCT02678572


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.

Official Title

A Single-arm, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients With Hepatic-Dominant Ocular Melanoma

Stanford Investigator(s)

Sunil Arani Reddy
Sunil Arani Reddy

Clinical Associate Professor, Medicine - Oncology


Inclusion Criteria:

   1. Male or female patients ≥ 18 years of age.

   2. Patients must weigh ≥ 35 kg (due to possible size limitations with respect to
   percutaneous catheterization of the femoral artery and vein using the Delcath Hepatic
   Delivery System).

   3. 50% or less histologically or cytologically-proven ocular melanoma metastases in the
   parenchyma of the liver.

   4. Disease in the liver must be measurable by computed tomography (CT) and/or magnetic
   resonance imaging (MRI).

   5. Evidence of limited extrahepatic disease on preoperative radiological studies is
   acceptable if the life threatening component of disease is in the liver. Limited
   extrahepatic disease is defined in this protocol as follows: metastasis in bone,
   subcutaneous, lung or lymph nodes that is amenable to resection or radiation and has a
   defined treatment plan. Patients with extra-hepatic tumor burden which does not have a
   defined treatment plan (i.e. monitor or is unable to be resected or radiated) must not
   be included in the trial.

   6. Scans used to determine eligibility (CT scan of the chest/abdomen/pelvis and MRI of
   the liver) must be performed within 28 days prior to randomization. An MRI of the
   liver is required at screening to validate that CT accurately reflects the extent of
   disease in the liver. For patients with MRI intolerance, a 3-phase liver CT is to be
   done in place of liver MRI.

   7. Patients must not have chemotherapy, radiotherapy, chemoembolization,
   radioembolization, or immunoembolization for their malignancy within 30 days prior to
   treatment and must have recovered from all side effects of therapeutic and diagnostic
   interventions except those listed in Appendix B of the study protocol.

   8. Patients receiving anti programmed cell death protein 1 (PD-1) immunotherapy such as
   pembrolizumab or nivolumab, or human cytotoxic T-lymphocyte antigen 4 blocking
   antibody such as ipilimumab should wait 8 weeks before Melphalan/HDS treatment.

   9. Patients must have an ECOG PS of 0-1 at screening and on the day prior to treatment.

10. Patients must have adequate hepatic function as evidenced by total serum bilirubin ≤
   1.5 x the upper limit of normal (ULN) and a prothrombin time (PT) within 2 seconds of
   the upper normal limit. Aspartate aminotransferase/alanine aminotransferase (AST/ALT)
   must be ≤ 2.5 x ULN.

11. Patients must have a platelet count > 100,000/µL, hemoglobin ≥ 10.0 gm/dL, white blood
   cell count (WBC) > 2,000/uL, absolute neutrophil count (ANC) ≥ 1.5 x 109/L, and a
   serum creatinine ≤ 1.5 mg/dL unless the measured creatinine clearance is > 40
   mL/min/1.73 m2.

12. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test
   (β-human chorionic gonadotropin) within 7 days prior to randomization.

13. Provided signed informed consent.

Exclusion Criteria:

   1. Patients with Child-Pugh Class B or C cirrhosis or with evidence of portal
   hypertension by history, endoscopy, or radiologic studies.

   2. Those with New York Heart Association functional classification II, III or IV active
   cardiac conditions, including unstable coronary syndromes (unstable or severe angina,
   recent myocardial infarction), worsening or new-onset congestive heart failure,
   significant arrhythmias and severe valvular disease must be evaluated for risks of
   undergoing general anesthesia.

   3. History or evidence of clinically significant pulmonary disease that precludes the use
   of general anesthesia.

   4. Women of childbearing potential (WOCBP) i.e. fertile meaning not permanently
   sterilized and having had a menstrual period within the past 12 months) unable to
   undergo hormonal suppression to avoid menstruation during treatment.

   5. WOCBP and fertile males (not permanently sterile by bilateral orchidectomy) unwilling
   or unable to use highly effective contraception method for consent to at least 6
   months after the last administration of study treatment (e.g. combined hormonal
   contraception; progestogen-only hormonal contraception; Intrauterine device,
   intrauterine hormone-releasing system; bilateral tubal occlusion, vasectomized partner
   or sexual abstinence).

   6. Females that are pregnant or breastfeeding patients

   7. Patients taking immunosuppressive drugs; however, oral corticosteroids ≤ 10 mg/day are

   8. Patients who are unable to be temporarily removed from chronic anti-coagulation

   9. Patients with active bacterial infections with systemic manifestations (malaise,
   fever, leucocytosis) are not eligible until completion of appropriate therapy.

10. Patients with severe allergic reaction to iodine contrast, which cannot be controlled
   by premedication with antihistamines and steroids (because a hepatic angiogram is
   needed for the Delcath system procedure).

11. Patients with a history of or known hypersensitivity to melphalan or the components of
   the Melphalan/HDS system.

12. Patients with latex allergy.

13. Patients with a history of hypersensitivity to heparin or the presence of
   heparin-induced thrombocytopenia.

14. Patients with a history of bleeding disorders or evidence of intracranial
   abnormalities which would put them at risk for bleeding with anti-coagulation (e.g.,
   strokes, active metastases).

15. Patients with a history of gastrinoma, hepatic vasculature incompatible with
   perfusion, hepatofugal flow in the portal vein or known unresolved venous shunting.

16. Known varices at risk of bleeding, including medium or large esophageal or gastric
   varices, or active peptic ulcer.

17. Patients with prior Whipple's procedure.

18. Patients with brain metastases or presence of other intracranial lesions at risk for
   bleeding by history or baseline radiologic imaging.

19. Patients with active liver infection, including Hepatitis B and Hepatitis C infection.
   Patients with anti-hepatitis B core antibody (HBc) positive, or hepatitis B surface
   antigen (HBsAg) but DNA negative are exception(s).

20. Uncontrolled endocrine disorders including diabetes mellitus, hypothyroidism, or

21. Received any investigational agent for any indication within 30 days prior to first

22. Not recovered from side effects of prior therapy to ≤ Grade 1 (according to National
   Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v. 4.03).
   Certain side effects that are unlikely to develop into serious or life-threatening
   events (e.g. alopecia) are allowed at > Grade 1.

23. Cancers other than ocular melanoma for which the patient is currently under treatment
   or still deemed not to be cancer free.


combination product: Melphalan/HDS

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Phuong Pham

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