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Virus Therapy
Gene Therapy for Liver Cancer
Phase 1
Waitlist Available
Research Sponsored by Kenneth K. Tanabe, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with hepatocellular carcinoma must have received sorafenib as one of the standard treatment options prior to being enrolled into the study
Subjects must have primary or metastatic liver malignancies which are surgically unresectable, and exhausted all standard therapeutic options
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment called rRp450 to see if it is safe and effective. rRp450 is a type of gene therapy that uses a modified version of the virus that causes cold sores (HSV-1) to target and kill cancer cells.
Who is the study for?
This trial is for adults with liver cancer that can't be removed by surgery and who have tried all standard treatments. They must not have had recent cancer therapies, their tumor should be less than half of the liver size, and they can't have brain metastases or certain other health conditions.Check my eligibility
What is being tested?
The trial tests rRp450, a gene therapy based on a modified herpes virus designed to target and kill cancer cells. It's delivered directly into the liver artery to see how safe it is, what dose is best, how it affects the body and its anti-cancer effects.See study design
What are the potential side effects?
Potential side effects may include typical reactions related to herpes virus such as cold sores but could also involve more severe infections due to immune system suppression caused by the treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have liver cancer and have been treated with sorafenib.
Select...
My liver cancer cannot be removed by surgery and I've tried all standard treatments.
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I am 18 or older and can understand and sign a consent form.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Characterize rRp450 pharmacokinetics and viral shedding.
Determine the dose-limiting toxicities and maximum dose of rRp450 that can be safely administered into the hepatic artery when administered weekly for four doses.
Evaluate the safety and tolerability of rRp450 administered into the hepatic artery as a single dose.
+1 moreSecondary outcome measures
Assess the relationship between systemic rRp450 levels and clinical toxicity.
Correlate radiographic and pathologic assessments of tumor response.
Evaluate tumor biopsies for rRp450 replication, tumor response and immune cell infiltrates.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Group 1Experimental Treatment1 Intervention
The first subjects will receive a single infusion of rRp450. Subsequent subjects will receive rRp450 as four doses administered every 1-2 weeks.
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Who is running the clinical trial?
Kenneth K. Tanabe, MDLead Sponsor
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,890 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on treatment for an active infection with antibiotics or anti-fungal medication.I have liver cancer and have been treated with sorafenib.I haven't had liver surgery, chemotherapy, immunotherapy, or liver radiotherapy in the last 4 weeks.I am currently taking medication that weakens my immune system.My tumor takes up less than half of my liver.I have fluid in my abdomen or a blocked main portal vein.I have a history of seizures.I don't have serious heart issues that can't be managed without my regular medication for 48 hours.I have been diagnosed with cirrhosis, hemochromatosis, or liver fibrosis.I do not have chronic hepatitis B or C, HIV, or liver problems.I don't have uncontrolled bleeding disorders and can stop blood thinners for 5 days.I have had a major liver surgery removing more than 2 segments.I have cancer that has spread to my liver or started in my liver, but it hasn't spread to my brain.My liver cancer cannot be removed by surgery and I've tried all standard treatments.I can care for myself and am expected to live more than 12 weeks.I am 18 or older and can understand and sign a consent form.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum capacity of participants for this research endeavor?
"Affirmative. Clinicaltrials.gov records show that this trial, which was published on October 1st 2010 is still active and recruiting participants. Forty individuals will be accepted from a single medical centre."
Answered by AI
Is this investigation currently taking applications from prospective participants?
"The information on clinicaltrials.gov suggests that this research is actively recruiting participants as of now. The study was first posted on October 1st 2010, and the latest edit to the listing occurred on November 23rd 2021."
Answered by AI
What safety protocols are in place when administering rRp450 into the hepatic artery?
"Given the limited safety and efficacy data, our team at Power judged that injection of rRp450 into a hepatic artery would be rated as 1 on a scale from 1 to 3."
Answered by AI
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