Viral Therapy for Liver Cancer

Recruiting in Palo Alto (17 mi)

Overseen byMitesh Borad, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase I trial studies the best dose and side effects of recombinant vesicular stomatitis virus expressing interferon beta in treating patients with liver cancer or solid tumors with lesions that have spread to other parts of the body and do not respond to treatment. The study virus has a gene inserted into it which will allow production of interferon beta, which is a substance that will restrict the spread of the virus to tumor cells and not healthy cells. It will also have some independent anti-cancer activity. Although the primary goal of this study is to evaluate the safety of delivery of this viral agent to people, patients may benefit clinically by having shrinkage or stabilization of their tumor or reduction in their cancer related symptoms (e.g., pain). Funding Source - FDA OOPD.

Research Team

Mitesh Borad, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

ARM A: INR =< 1.5 x ULN

ARM A: aPTT =< 1.5 x ULN

ARM A: Life expectancy >= 12 weeks

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Exclusion Criteria

ARM A: Uncontrolled infection

I am not receiving any other cancer treatments.

ARM B: Any condition, which in the opinion of the investigator would render the patient unsuitable to participate in the study

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Treatment Details

Interventions

Recombinant Vesicular Stomatitis Virus-expressing Interferon-beta (Virus Therapy)

Trial OverviewThe 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.

Participant Groups

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.