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Virus Therapy
Modified Virus Therapy for Advanced Skin Cancer
Phase 1
Waitlist Available
Led By Roxana S. Dronca, 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
For cutaneous melanoma patients: at least one prior FDA approved systemic therapy in the metastatic setting and disease progression after immune checkpoint inhibitors
Injectable disease defined as at least 1 injectable and safely accessible cutaneous, subcutaneous, or nodal melanoma lesion >= 5 mm in longest diameter for metastatic cutaneous or mucosal melanoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is studying a modified virus that may help to treat patients with stage III-IV melanoma.
Who is the study for?
This trial is for adults over 18 with stage III-IV melanoma, including ocular melanoma. Participants must have tried FDA-approved systemic therapy and progressed after immune checkpoint inhibitors. For those with BRAF mutations, prior targeted therapies are needed. They should have at least one injectable tumor lesion and a life expectancy of 12+ weeks. Contraception use is required during the study and for 120 days after.Check my eligibility
What is being tested?
The trial tests a modified virus called VSV-IFNbetaTYRP1 on patients with advanced melanoma to see if it's safe and what dose works best. The virus has been changed to include genes that might protect healthy cells and help the immune system attack melanoma cells.See study design
What are the potential side effects?
Potential side effects aren't detailed here but may relate to how the body responds to the introduction of foreign genetic material designed to stimulate an immune response against cancer cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have skin cancer that worsened after treatment with specific immune drugs.
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I have a melanoma spot or node that can be injected and is at least 5 mm big.
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I am 18 years old or older.
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My melanoma cannot be removed by surgery and has spread to other parts.
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I am fully active or can carry out light work.
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I have had treatments targeting BRAF or MEK for my melanoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Maximum-tolerated dose
Secondary outcome measures
Overall survival
Tumor response rate
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group B (VSV-IFNbetaTYRP1)Experimental Treatment1 Intervention
Patients receive recombinant vesicular stomatitis virus-expressing interferon-beta and tyrosinase related protein 1 IT and IV over 30-60 minutes 2-4 hours later on day 1. Cycle 1 continues for 28 days, with subsequent cycles repeating every 21 days in the absence of disease progression or unacceptable toxicity.
Group II: Group A (VSV-IFNbetaTYRP1)Experimental Treatment1 Intervention
Patients receive recombinant vesicular stomatitis virus-expressing interferon-beta and tyrosinase related protein 1 IT and IV over 30-60 minutes 2-4 hours later on day 1.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,071 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,655 Total Patients Enrolled
4 Trials studying Cutaneous Melanoma
198 Patients Enrolled for Cutaneous Melanoma
Roxana S. Dronca, M.D.Principal InvestigatorMayo Clinic
2 Previous Clinical Trials
250 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active skin issues, received vaccines for infections, and need blood thinners.I have melanoma and a weakened immune system.You have a detectable disease that can be seen on scans or imaging tests.I have a history of tuberculosis, HIV, or hepatitis B/C.I have skin cancer that worsened after treatment with specific immune drugs.Women who can have babies need to have a negative pregnancy test within 7 days before joining the study.I am willing and able to follow the study's schedule and procedures.I have a melanoma spot or node that can be injected and is at least 5 mm big.There is a known treatment that could cure or extend my life.I have followed all timing rules for my past treatments and vaccines.I have had liver radioembolization for ocular melanoma within the last 90 days.My cancer has spread to my brain.I do not have any uncontrolled illnesses or infections.I am 18 years old or older.My melanoma cannot be removed by surgery and has spread to other parts.I am fully active or can carry out light work.You are expected to live for at least 12 more weeks.I have had treatments targeting BRAF or MEK for my melanoma.I haven't had any cancer other than non-dangerous skin or cervical cancer in the last 3 years.I have had or am planning to have surgery or radiation on my spleen.My eye melanoma has spread, and my liver and blood tests meet specific criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Group B (VSV-IFNbetaTYRP1)
- Group 2: Group A (VSV-IFNbetaTYRP1)
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.
Has the FDA cleared Recombinant Vesicular Stomatitis Virus-expressing Interferon-beta and Tyrosinase Related Protein 1 for use?
"Data supporting the safety and efficacy of Recombinant Vesicular Stomatitis Virus-expressing Interferon-beta and Tyrosinase Related Protein 1 is limited, thus our team at Power assigned it a score of 1."
Answered by AI
What is the current capacity of participants for this research?
"This trial has completed its search for volunteers and updated their information on August 9th, 2022. If you are still searching for studies to join, 827 trials involving melanoma patients are currently recruiting and 5 trials related to Recombinant Vesicular Stomatitis Virus-expressing Interferon-beta and Tyrosinase Related Protein 1 have open spots available."
Answered by AI
Are there any openings remaining for enrollment in this experiment?
"This specific clinical trial, which was first published on June 12th 2019 and recently updated August 9th 2022, is not currently recruiting. However, there are 832 other trials actively sourcing participants at the current moment."
Answered by AI
Have any other research endeavors delved into the effects of Recombinant Vesicular Stomatitis Virus-expressing Interferon-beta and Tyrosinase Related Protein 1?
"In 2012, the Mayo Clinic in Arizona initiated research into Recombinant Vesicular Stomatitis Virus-expressing Interferon-beta and Tyrosinase Related Protein 1. This particular topic has thus far been explored through 29 studies, 5 of which are still active with many taking place at Rochester Medical Centre in Minnesota."
Answered by AI
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