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Hepatocellular Carcinoma (HCC)Phase 2NCT02406508

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

A Phase 2 study testing Melphalan/HDS and Sorafenib in people with Hepatocellular Carcinoma (HCC), run by Delcath Systems Inc. at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma (HCC)
What is being tested?
Melphalan/HDS and Sorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesUnited States
Study dates
Oct 2014to Dec 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 30Show fewer
  • 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
  • Aspartate aminotransferase (AST) or alanine transaminase (ALT) > 5 times ULN
  • Serum albumin < 3.0 g/dL
  • Alcohol consumption within 30 days of first study treatment, or refusing to abstain from alcohol for the duration of study treatment
  • For female subjects of childbearing potential (i.e., have had a menstrual period within the past 12 months): a positive serum pregnancy test (β-human chorionic gonadotropin) within 7 days prior to enrollment; or unwilling or unable to undergo hormonal suppression to avoid menstruation during treatment
  • 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 30 days after last administration of study treatment

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Montefiore Medical Center

    New York, New York, 10467

  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: An International Multi-center Phase 2 Study to Evaluate the Safety and Efficacy of Sequential Melphalan Hydrochloride for Injection for Use With the Hepatic Delivery System Treatment Followed by Sorafenib in Patients With Unresectable Hepatocellular Carcinoma

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.

Read the detailed description

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.

Eligible patients will receive up to 3 Melphalan/HDS treatments. Each treatment cycle consists of 6 weeks with an acceptable delay for another 2 weeks before next planned treatment. The Melphalan/HDS treatment will be terminated in patients with progressive disease (PD), complete response (CR), and > 8 weeks delay of recovery from toxicity after last PHP treatment.

With the exception of patients with PD, all patients will be treated with sorafenib after completing the Melphalan/HDS treatment. Patients with PD will be managed with standard of care off-study by their treating physician.

Being tested
Melphalan/HDS, Sorafenib
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Melphalan/HDSDevice

    Also called Melphalan/Hepatic Delivery System, Percutaneous hepatic perfusion (PHP)

  • SorafenibDrug

    Also called Nexavar

Study groups in NCT02406508
Study groupRoleWhat they receive
Hepatic Delivery System Treatment followed by SorafenibExperimentalPercutaneous hepatic perfusion with melphalan hydrochloride for injection using the Hepatic Delivery System. Melphalan hydrochloride is administered at a dose of 3mg/kg ideal body weight once every 6 weeks for a maximum of 3 cycles of treatment. After the Melphalan/HDS treatment patients will be treated with sorafenib according to the package prescribing information.
Receives: Device: Melphalan/HDS; Drug: Sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with adverse events after treatment with Melphalan/HDS.

    Measured: 2 years

  2. Number of patients with adverse events after treatment with Sorafenib following treatment with Melphalan/HDS.

    Measured: 2 years

  3. Objective response rate in percentage of Melphalan/HDS treatment

    Measured: 2 years

  4. Progression free survival in months of patients receiving Melphalan/HDS treatment followed by Sorafenib

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2015 (estimated)
  2. Study startOct 2014
  3. Primary completionDec 2017
  4. Study completionDec 2017

Why it stopped: No enrollment in the study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02406508
Sponsor's protocol ID
PHP-HCC-201
Status last verified
Dec 2017
First submitted
23 Mar 2015
Last updated
18 Dec 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Melphalan/HDS and Sorafenib in people with Hepatocellular Carcinoma (HCC), run by Delcath Systems Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with adverse events after treatment with Melphalan/HDS. (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02406508.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017.

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