Sequential Melphalan for Use With Hepatic Delivery System Treatment Followed by Sorafenib in Patients With Unresectable HCC

Withdrawn before enrolling · Phase 2

Conditions studied: Hepatocellular Carcinoma (HCC)

In brief

This is a single arm, open label, multi-center, phase 2 study to evaluate the safety and efficacy of sequential treatment with Melphalan/HDS followed by sorafenib in patients with unresectable hepatocellular carcinoma (HCC) confined to the liver.

Key facts

Study ID

NCT02406508

Run by

Delcath Systems Inc.

People needed

0

Starts

2014-10-01

Expected to finish

2017-12-01

Last updated by the study team

2017-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HCC diagnosed by tissue or imaging study
• Unresectable HCC without extrahepatic disease based on CT
• At least one target lesion. In patients with prior loco-regional therapy, the target lesion(s) must be located in area(s) outside previous treatment
• Child-Pugh Class A in the absence of hepatoencephalopathy or clinically evident ascites
• Barcelona Clinic Liver Cancer (BCLC) stage B
• MELD Score < 15
• Eastern Cooperative Oncology Group Performance Status 0-1
• No prior systemic therapy for HCC
• No prior radiation therapy to the liver including Y90-, I131-based loco-regional therapy. Prior loco-regional therapy based on other technology for HCC, if any, must have been completed at least 4 weeks prior to baseline imaging
• Age ≥ 18 years
• Signed informed consent

You may not qualify if…

• Metastatic disease outside of liver
• Greater than 50% tumor burden in the liver by imaging
• History of orthotopic liver transplantation, clinical symptoms of portal hypertension, Whipple's procedure, hepatic artery anatomy incompatible with perfusion or known unresolved venous shunting
• Evidence of ascites on imaging study, or the use of diuretics for ascites
• Clinically significant encephalopathy
• History of allergies or known hypersensitivity to any components of melphalan or the components of the Melphalan/HDS system
• Known hypersensitivity to heparin or the presence of heparin-induced thrombocytopenia
• Received an investigational agent for any indication within 30 days prior to first treatment
• Not recovered from side effects of prior therapy to ≤ grade 1 (according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 [NCI 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
• 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
• History or evidence of clinically significant pulmonary disease that precludes the use of general anesthesia
• Uncontrolled diabetes mellitus, hypothyroidism, or hyperthyroidism
• Active uncontrolled infection, including Hepatitis B, Hepatitis C infection. Patients with anti-HBc positive, or HBsAg but DNA negative are exception(s)
• History of bleeding disorders
• Brain lesions with a propensity to bleed
• Known esophageal varices at risk of bleeding, including medium or large esophageal or gastric varices, or active peptic ulcer
• Previous malignancy within 3 years prior to enrollment, except for curatively-treated basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, bladder carcinoma in situ or breast cancer in situ
• Inadequate hematologic function as evidenced by any of the following:
• Platelets < 125,000/µL
• Hemoglobin ≤ 10 g/dL, independent of transfusion or growth factor support
• Neutrophils < 1,500/µL
• Serum creatinine > 1.5 mg/dL
• Inadequate liver function as evidenced by any of the following:
• Total serum bilirubin ≥ 2.0 mg/dL
• Prothrombin time International Normalized Ratio (INR) > 1.5

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute at University of South Florida — Tampa, Florida, United States
• Montefiore Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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