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Hepatocellular CarcinomaPhase 2NCT02415036

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

A Phase 2 study testing Delcath Hepatic Delivery System and Melphalan in people with Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma, run by Delcath Systems Inc. at 3 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Delcath Hepatic Delivery System and Melphalan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
3 sitesGermany
Study dates
Jun 2014to Dec 2018
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

  • 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.
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  • 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.
  • 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 ICC, if any, must have been completed at least 4 weeks prior to baseline imaging.
  • Age ≥ 18 years.
  • Signed informed consent.

Who cannot join

  • 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.
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  • 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.
  • Brain lesions with a propensity to bleed.
  • Known 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 < 90,000/µL
  • Hemoglobin < 8 g/dL, independent of transfusion or growth factor support
  • Neutrophils < 1,500 cells/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 (PT)/international normalized ratio (INR) > 1.5
  • Aspartate aminotransferase (AST) > 10 times the upper limit of normal (ULN) or alanine aminotransferase (ALT) > 5 times ULN
  • Serum albumin < 3.0 g/dL.
  • Known alcohol abuse.
  • 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 [β HCG]) 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

3 sites in 1 country.

Germany3 sites

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Jena

    Jena, 07747

Other trials in Germany

About this study

Official title: 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

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.

Read the 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.

Being tested
Delcath Hepatic Delivery System, Melphalan
Keywords
HCC, ICC, Percutaneous hepatic perfusion
Medical subject headings
Carcinoma, Hepatocellular, Cholangiocarcinoma

What participants receive

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

  • Delcath Hepatic Delivery SystemDevice

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

  • MelphalanDrug

Study groups in NCT02415036
Study groupRoleWhat they receive
Melphalan/HDS treatment of patients with HCCExperimentalPercutaneous 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.
Receives: Device: Delcath Hepatic Delivery System; Drug: Melphalan
Melphalan/HDS treatment of patients with ICCExperimentalPercutaneous 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.
Receives: Device: Delcath Hepatic Delivery System; Drug: Melphalan

What is being measured

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

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

    Measured: 2 years

Secondary outcomes (2)

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

    Measured: 2 years

  2. Progression free survival in months of patients receiving Melphalan/HDS treatment.

    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 posted14 Apr 2015 (estimated)
  2. Study startJun 2014
  3. Primary completionOct 2018
  4. Study completionDec 2018

Why it stopped: Limited enrollment

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02415036
Sponsor's protocol ID
PHP-HCC-202
Status last verified
Oct 2022
First submitted
8 Apr 2015
Last updated
17 Oct 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Delcath Hepatic Delivery System and Melphalan in people with Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma, run by Delcath Systems Inc. at 3 sites in Germany.

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 18 inclusion and 31 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: stopped early, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. 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 stopped early (reason given: Limited enrollment). Results are not available in the source record.

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?

Objective response rate in percentage of Melphalan/HDS treatment (time frame: 2 years). 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 NCT02415036.

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 17 Oct 2022.

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