EUCTR2015-000417-44-IT进行中（未招募）1 期
A Randomized, Controlled, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients with Hepatic-Dominant Ocular Melanoma. - A Randomized, Controlled, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Mel
DELCATH SYSTEMS, INCORPORATIONS0 个研究点目标入组 240 人开始时间: 2017年12月15日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 PD is in the liver. Limited extrahepatic disease is defined in
- •this protocol as follows: metastasis in up to one other organ (bone, subcutaneous, or pulmonary),
- •limited to up to 2 nodules and amenable to resection or radiation. The extrahepatic lesions
- •should be no larger than 2 cm in diameter each. The rationale for permitting this limited extrahepatic disease is that these types of lesions are amenable to surgical resection or radiation.
- •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.
- •7. Patients must have had no chemotherapy or radiotherapy for their malignancy in the month 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. 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.
- •8. Patients must have an ECOG PS of 0-1 at screening and on the day prior to treatment.
- •9. 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.
- •10. 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 = 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 192
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 48
排除标准
- •Patients who meet any of the following criteria will be excluded from study entry:
- •1. Patients with Child-Pugh Class B or C cirrhosis or with evidence of portal hypertension by history, endoscopy, or radiologic
- •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. For female patients of childbearing potential (i.e., have had a menstrual period within the past 12 months): unwilling or unable
- •to undergo hormonal suppression to avoid menstruation during treatment.
- •5. For female patients of childbearing potential (i.e. have had a menstrual period within the past 12
- •months): a positive serum pregnancy test (ß-human chorionic gonadotropin) within 7 days prior to enrollment.
- •6. Sexually active females of childbearing potential and sexually active males with partners of reproductive potential: unwilling or
- •unable to use appropriate contraception from screening until
- •at least 4 months after last administration of study treatment.
- •7. Lactating women are excluded from study participation.
- •8. Patients taking immunosuppressive drugs or who are unable to be temporarily removed from chronic anti-coagulation therapy.
- •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 previously treated with any intra-arterial regional hepatic therapy.
- •13. Patients with latex allergy.
- •14. Patients with a history of hypersensitivity to heparin or the presence of heparin-induced thrombocytopenia.
- •15. 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).
- •16. Patients with a history of gastrinoma, hepatic vasculature incompatible with perfusion, hepatofugal flow in the portal vein or
- •known unresolved venous shunting.
- •17. Known varices at risk of bleeding, including medium or large esophageal or gastric varices, or
- •active peptic ulcer.
- •18. Patients with prior Whipple’s procedure.
- •19. Patients with 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. 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 hyperthyroidism.
- •21. Received any investigational agent for any indication within 30 days prior to first treatment.
- •22. Not recovered from side effects of prior therapy to = Grade 1 (according to National Cancer Institute (NCI) Comm
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