An International Multi-center Phase 2 Study to Evaluate the Efficacy and Safety of Melphalan Hydrochloride for Injection for Use With the Hepatic Delivery System Treatment in Patients With Unresectable Hepatocellular Carcinoma or Intra Hepatic Cholangiocarcinoma
Overview
- Phase
- Phase 2
- Intervention
- Delcath Hepatic Delivery System
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Delcath Systems Inc.
- Enrollment
- 17
- Locations
- 3
- Primary Endpoint
- Objective response rate in percentage of Melphalan/HDS treatment
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a two arm, open label, multi-center, Phase 2 study to evaluate the efficacy and safety of Melphalan/HDS in patients with unresectable Hepatocellular Carcinoma (HCC) or Intra Hepatic Cholangiocarcinoma (ICC) confined to the liver.
Detailed Description
This is a two arm, open label, multi-center, Phase 2 study to evaluate the efficacy and safety of Melphalan/HDS in patients with unresectable HCC or ICC confined to the liver. Eligible patients will receive up to 2 Melphalan/HDS treatments. Each treatment cycle consists of 6 weeks with an acceptable delay for another 2 weeks before next planned treatment. Tumor response will be assessed at the end of cycle 2. The Melphalan/HDS treatment will be terminated in patients with progressive disease (PD) after the 1st treatment and based on safety in patients with \> 8 weeks delay of recovery from toxicity.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with HCC must meet all of the following criteria for study entry:
- •HCC diagnosed by tissue or imaging study.
- •Unresectable HCC without clinically significant extra hepatic disease (minor lesions \[≤ 1 cm and not consistent with metastatic disease\] acceptable) based on computed tomography (CT).
- •At least one target lesion based on mRECIST. In patients with prior loco-regional therapy, the target lesion(s) must be located in area(s) outside previous treatment or must have progressed after prior treatment if located within previous treatment field.
- •Child-Pugh Class A.
- •No prior radiation therapy to the liver including Y90-, I131-based loco-regional therapy. Prior loco regional therapy, including resection, 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.
- •Patients with ICC must meet all of the following criteria for study entry:
- •ICC diagnosed by tissue or imaging study.
Exclusion Criteria
- •For the HCC cohort, patients for whom transplantation, radiofrequency ablation (RFA), transarterial chemoembolization (TACE), or systemic treatment with sorafenib are better therapeutic options are to be excluded from study entry.
- •Additionally, for both the HCC and ICC cohorts, patients who meet any of the following criteria will be excluded from study entry:
- •Greater than 50% tumor burden in the liver by imaging.
- •History of orthotopic liver transplantation, Whipple's procedure, hepatic vasculature incompatible with perfusion, hepatofugal flow in the portal vein or known unresolved venous shunting.
- •Evidence of ascites on imaging study, or the use of diuretics for ascites.
- •Clinically significant encephalopathy.
- •History of, 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 \[NCI\] CTCAE version 4.03). Certain side effects that are unlikely to develop into serious or life-threatening events (e.g. alopecia) are allowed at \> Grade
Arms & Interventions
Melphalan/HDS treatment of patients with HCC
Percutaneous hepatic perfusion with melphalan hydrochloride for injection using the Hepatic Delivery System on patients with Hepatocellular carcinoma (HCC). Melphalan hydrochloride is administered at a dose of 3mg/kg ideal body weight once every 6 weeks for a maximum of 2 cycles of treatment.
Intervention: Delcath Hepatic Delivery System
Melphalan/HDS treatment of patients with HCC
Percutaneous hepatic perfusion with melphalan hydrochloride for injection using the Hepatic Delivery System on patients with Hepatocellular carcinoma (HCC). Melphalan hydrochloride is administered at a dose of 3mg/kg ideal body weight once every 6 weeks for a maximum of 2 cycles of treatment.
Intervention: Melphalan
Melphalan/HDS treatment of patients with ICC
Percutaneous hepatic perfusion with melphalan hydrochloride for injection using the Hepatic Delivery System on patients with Intrahepatic cholangiocarcinoma (ICC). Melphalan hydrochloride is administered at a dose of 3mg/kg ideal body weight once every 6 weeks for a maximum of 2 cycles of treatment.
Intervention: Delcath Hepatic Delivery System
Melphalan/HDS treatment of patients with ICC
Percutaneous hepatic perfusion with melphalan hydrochloride for injection using the Hepatic Delivery System on patients with Intrahepatic cholangiocarcinoma (ICC). Melphalan hydrochloride is administered at a dose of 3mg/kg ideal body weight once every 6 weeks for a maximum of 2 cycles of treatment.
Intervention: Melphalan
Outcomes
Primary Outcomes
Objective response rate in percentage of Melphalan/HDS treatment
Time Frame: 2 years
Secondary Outcomes
- Number of patients with adverse events after treatment with Melphalan/HDS.(2 years)
- Progression free survival in months of patients receiving Melphalan/HDS treatment.(2 years)