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Virus Therapy

Viral Therapy for Liver Cancer

Phase 1
Waitlist Available
Led By Mitesh Borad
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

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.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,175 Previous Clinical Trials
3,758,144 Total Patients Enrolled
4 Trials studying Liver Cancer
9,361 Patients Enrolled for Liver Cancer
National Cancer Institute (NCI)NIH
13,604 Previous Clinical Trials
40,913,270 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer
Mitesh BoradPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
14 Total Patients Enrolled

Media Library

Recombinant Vesicular Stomatitis Virus-expressing Interferon-beta (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01628640 — Phase 1
Liver Cancer Research Study Groups: Arm A (viral therapy in single tumor location), Arm B (viral therapy in multiple locations)
Liver Cancer Clinical Trial 2023: Recombinant Vesicular Stomatitis Virus-expressing Interferon-beta Highlights & Side Effects. Trial Name: NCT01628640 — Phase 1
Recombinant Vesicular Stomatitis Virus-expressing Interferon-beta (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01628640 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an intake process currently in place for this research endeavor?

"Per the clinicaltrials.gov platform, this medical trial is not currently enrolling any individuals; however it was first posted on August 3rd 2012 and last updated October 7th 2022. Currently, there are 2680 other trials actively recruiting patients to participate in research studies."

Answered by AI

Could you outline any previous investigations into the therapeutic effects of Pharmacological Study?

"At present, 5 experiments on Pharmacological Study are in progress with 1 of them being tested at the late-stage. The majority of these tests take place in Scottsdale, Arizona; however there are 133 other places that offer trials for this same medication."

Answered by AI

Has the Pharmacological Study been given approval from the FDA?

"We have assigned a score of 1 to the safety profile for this pharmacological study, as it is only at Phase 1 and thus has limited evidence showing its efficacy or risk."

Answered by AI

What is the current sample size of this research endeavor?

"This clinical trial has concluded its recruitment process, having started on August 3rd 2012 and ending October 7th 2022. Nonetheless, there are currently 2675 trials for liver carcinoma that still need participants as well 5 Pharmacological Studies welcoming volunteers."

Answered by AI
~1 spots leftby Mar 2025