Melphalan for Use With the Hepatic Delivery System Treatment in Patients With Unresectable Hepatocellular Carcinoma or Intra Hepatic Cholangiocarcinoma

NCT02415036 | Terminated Phase 2

• 1 other identifier: PHP-HCC-202
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

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.

Conditions

Hepatocellular Carcinoma; Intrahepatic Cholangiocarcinoma

Keywords

HCC; ICC; Percutaneous hepatic perfusion

Outcome Measures

Primary Outcomes (1)

• Objective response rate in percentage of Melphalan/HDS treatment

  2 years

Secondary Outcomes (2)

• 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

Study Arms (2)

Melphalan/HDS treatment of patients with HCC

EXPERIMENTAL

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.

Device: Delcath Hepatic Delivery System; Drug: Melphalan

Melphalan/HDS treatment of patients with ICC

EXPERIMENTAL

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.

Device: Delcath Hepatic Delivery System; Drug: Melphalan

Interventions

Delcath Hepatic Delivery System DEVICE

Also known as: Melphalan/Hepatic Delivery System, Percutaneous hepatic perfusion (PHP)

Melphalan/HDS treatment of patients with HCC; Melphalan/HDS treatment of patients with ICC

Melphalan DRUG

Melphalan/HDS treatment of patients with HCC; Melphalan/HDS treatment of patients with ICC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ECOG PS 0-1.
• 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.
• Unresectable ICC without clinically significant extra hepatic disease (minor lesions \[≤ 1 cm and not consistent with metastatic disease\] acceptable) based on 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.
• ECOG PS 0-1.

You may not qualify if:

• 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 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 infection, including Hepatitis B and Hepatitis C infection. Patients with anti-hepatitis B core antigen (HBc) positive, or hepatitis B surface antigen (HBsAg) but viral deoxyribonucleic acid (DNA) negative are exception(s).
• History of bleeding disorders.

Sponsors & Collaborators

• Delcath Systems Inc.: lead

Study Sites (3)

Universitätsklinikum Frankfurt

Frankfurt, 60590, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsklinikum Jena

Jena, 07747, Germany

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Cholangiocarcinoma

Interventions

Melphalan

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Johnny John, MD

  Delcath Systems

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 14, 2015
• Study Start: June 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 17, 2022

Record last verified: 2022-10

Locations

DE (3)