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Virus Therapy

Viral Therapy for Liver Cancer

Phase 1

Waitlist Available

Led By Mitesh J. Borad, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ARM A: Predominant intrahepatic burden (> 75%) of disease

ARM B: Histologically or cytologically confirmed solid tumor with subcutaneous/cutaneous lesions that is refractory to or intolerant to standard therapy

Must not have

ARM B: Other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy

ARM A: Other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is studying a new virus that has been genetically engineered to produce interferon beta, which may help to treat patients with liver cancer or other solid tumors that have spread to other parts of the body and are not responding to treatment.

Who is the study for?

This trial is for adults with advanced liver cancer or solid tumors that have spread and are not responding to treatment. Participants must meet specific health criteria like certain blood cell counts, liver function tests, and life expectancy of at least 12 weeks. Pregnant women, those with organ transplants, uncontrolled infections, HIV, or recent corticosteroid use cannot join.

What is being tested?

The trial is testing a genetically modified virus designed to target cancer cells without harming healthy ones. It carries a gene for interferon beta which may help control the tumor's growth. The study aims to find the safest dose while observing any potential benefits such as tumor shrinkage.

What are the potential side effects?

Potential side effects include typical reactions related to immune stimulation by interferon-beta such as flu-like symptoms (fever, chills), fatigue, headache and muscle pain. As this is an investigational therapy, there may be unknown risks involved.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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Most of my liver cancer is inside my liver.

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My cancer is confirmed and has skin lesions, and standard treatments haven't worked or caused side effects.

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My liver function is classified as Child-Pugh A.

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My liver cancer affects less than 25% of my liver.

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My liver cancer hasn't responded to or I can't tolerate sorafenib, or my advanced cancer mainly affects the liver and has worsened despite treatment.

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I am fully active or restricted in physically strenuous activity but can do light work.

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Less than 25% of my liver is affected by the disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not receiving any other cancer treatments.

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I am not receiving any other cancer treatments while on ARM A.

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I have had a bone marrow or organ transplant.

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Surgery or liver transplant is a better option for me than ARM A treatment.

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I do not have any infections that are currently uncontrolled.

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I am HIV positive.

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I have had a bone marrow or organ transplant.

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I have not used any corticosteroids in the last 28 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Best tumor response, defined as the best objective status recorded among patients with measurable disease at baseline using Response Evaluation Criteria in Solid Tumors version 1.1

Incidence of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Maximum tolerated dose, defined as the highest dose at which no more than 1/6 patients experiences dose limiting toxicities, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

+2 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (viral therapy in multiple locations)Experimental Treatment3 Interventions

Patients with advanced solid tumor with subcutaneous/cutaneous lesions receive recombinant vesicular stomatitis virus expressing interferon beta intratumorally in up to 5 cutaneous, subcutaneous, or soft tissue tumor lesions on day 1.

Group II: Arm A (viral therapy in single tumor location)Experimental Treatment3 Interventions

Patients with hepatocellular carcinoma or advanced solid tumor with liver lesions receive recombinant vesicular stomatitis virus expressing interferon beta intratumorally in a single tumor location on day 1.

0 / 15Eligibility criteria met