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Clinical Trial 18569

Cancer Type:
Interventions:Alkeran (Melphalan); DTIC (Dacarbazine); Dacarbazine; Ipilimumab; Melphalan; Pembrolizumab (Keytruda); Yervoy (Ipilimumab)

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Jonathan Zager

Overview

Study Title

A Randomized, Controlled, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients with Hepatic-Dominant Ocular Melanoma

Summary

The purpose of this study is to study the effectiveness of melphalan treatment.

Objective

Objectives: Primary Objective: To compare overall survival (OS) in patients with hepatic-dominant metastatic ocular melanoma treated with Melphalan/HDS versus best alternative care (BAC). Secondary Objectives: To compare the overall progression-free survival (PFS) (as determined by the Investigator) of patients with hepatic-dominant metastatic ocular melanoma treated with Melphalan/HDS versus control (BAC). To compare the objective response rate (ORR = complete + partial response) (as determined by the Investigator) of treatment with Melphalan/HDS versus control (BAC) in patients with hepatic-dominant metastatic ocular melanoma. Exploratory Objectives: To compare the PFS (as determined by Independent Central Review) of patients with hepatic-dominant metastatic ocular melanoma treated with Melphalan/HDS versus control (BAC). To compare the ORR (as determined by Independent Central Review) of treatment with Melphalan/HDS versus control (BAC) in patients with hepatic-dominant metastatic ocular melanoma. To compare the hepatic progression-free survival (hPFS) (as determined by Independent Central Review) of patients with hepatic-dominant metastatic ocular melanoma treated with Melphalan/HDS versus control (BAC). To compare the hepatic objective response rate (hORR) (as determined by Independent Central Review) of treatment with Melphalan/HDS versus control (BAC) in patients with hepatic-dominant metastatic ocular melanoma. To compare the quality of life (QOL) in patients with hepatic-dominant metastatic ocular melanoma treated with Melphalan/HDS versus control (BAC). To evaluate the safety of treatment with Melphalan/HDS in patients with hepatic-dominant metastatic ocular melanoma. To explore relationships between melphalan exposure and common or serious adverse reactions and clinical outcomes. To characterize the local and systemic exposure of Melphalan administered by the HDS.

Inclusion Criteria

  • Males or females ≥ 18 years of age
  • Must weigh ≥ 35 kg
  • 50% or less histologically or cytologically-proven ocular melanoma metastases in the parenchyma of the liver
  • Disease in the liver must be measurable by computed tomography (CT) and/or magnetic resonance imaging (MRI).
  • Evidence of limited extrahepatic disease on preoperative radiological studies is acceptable if the life threatening component of progressive disease (PD) is in the liver
  • 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.
  • Must not have had chemotherapy, radiotherapy, chemoembolization, radioembolization, or immunoembolization for their malignancy in the month prior to treatment and must have recovered from all side effects of therapeutic and diagnostic interventions, with few exceptions.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at screening and on the day prior to treatment
  • Adequate hepatic function
  • 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 10^9/L, and a serum creatinine ≤ 1.5 mg/dL unless the measured creatinine clearance is > 40 mL/min/1.73 m^2

    • Exclusion Criteria

  • Potential participants with Child-Pugh Class B or C cirrhosis or with evidence of portal hypertension by history, endoscopy, or radiologic studies
  • New York Heart Association functional classification II, III or IV active cardiac conditions, including unstable coronary syndromes, worsening or new-onset congestive heart failure, significant arrhythmias and severe valvular disease must be evaluated for risks of undergoing general anesthesia.
  • History or evidence of clinically significant pulmonary disease that precludes the use of general anesthesia
  • Women of childbearing potential (WOCBP) unwilling or unable to undergo hormonal suppression to avoid menstruation during treatment
  • For WOCBP, a positive serum pregnancy test (β-human chorionic gonadotropin) within 7 days prior to enrollment
  • Unwilling or unable to use appropriate contraception from screening until at least 4 - 6 months after last administration of study treatment
  • Women who are lactating
  • Taking immunosuppressive drugs or who are unable to be temporarily removed from chronic anti-coagulation therapy
  • Active bacterial infections with systemic manifestations, until completion of appropriate therapy
  • Severe allergic reaction to iodine contrast, which cannot be controlled by premedication with antihistamines and steroids
  • History of or known hypersensitivity to melphalan or the components of the Melphalan/HDS system
  • A latex allergy
  • History of hypersensitivity to heparin or the presence of heparin-induced thrombocytopenia
  • 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).
  • History of gastrinoma, hepatic vasculature incompatible with perfusion, hepatofugal flow in the portal vein or known unresolved venous shunting
  • Known varices at risk of bleeding, including medium or large esophageal or gastric varices, or active peptic ulcer
  • Pprior Whipple's procedure
  • Brain metastases or presence of other intracranial lesions at risk for bleeding by history or baseline radiologic imaging. Active infection, including Hepatitis B and Hepatitis C infection. Exceptions: Anti-hepatitis B core antibody (HBc) positive, or hepatitis B surface antigen (HBsAg) but DNA negative are exception.
  • Uncontrolled endocrine disorders including diabetes mellitus, hypothyroidism, or hyperthyroidism
  • Received any investigational agent for any indication within 30 days prior to first treatment
  • Not recovered from side effects of prior therapy to ≤ Grade 1

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