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Virus Therapy

Measles Virus-Based Vaccine for Breast Cancer

Phase 1

Recruiting

Led By Minetta C Liu

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

Age >= 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is investigating the side effects and best dose of a modified measles virus, MV-s-NAP, in treating patients with metastatic breast cancer.

Who is the study for?

Adults with invasive breast cancer that has spread (metastatic) and no curative standard therapy available. Must have good organ function, acceptable blood counts, ECOG status 0-2, and a life expectancy of at least 12 weeks. Cannot be pregnant or have had certain treatments recently.Check my eligibility

What is being tested?

The trial is testing MV-s-NAP, a modified measles virus designed to target and destroy breast cancer cells by producing an inflammatory protein called NAP. The study will determine the best dose and monitor its effects on metastatic breast cancer through various tests.See study design

What are the potential side effects?

Potential side effects may include typical reactions to vaccines such as fever or rash, inflammation due to the immune response triggered by NAP protein production, and possible tissue damage at tumor sites where the virus is administered.

Eligibility Criteria

Inclusion Criteria

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

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I am able to care for myself and perform daily activities.

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I am 18 years old or older.

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There are no curative treatment options available for my condition.

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My breast cancer has spread, and its ER/PR/HER2 status is known.

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I have a cancer spot larger than 1 cm, or over 2 cm in my lungs, that can be safely treated with an injection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Incidence of adverse events

Maximum tolerated dose

+2 more

Secondary outcome measures

Overall survival time

Progression-free survival time

Tumor response

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (MV-s-NAP)Experimental Treatment1 Intervention

Patients receive MV-s-NAP intratumorally (IT) on day 1 in the absence of disease progression or unacceptable toxicity. After 1 cycle of treatment, patients who experience disease progression proceed to follow-up. Patients who achieve CR, PR, or SD receive MV-s-NAP IT every 21 days for up to 3 additional cycles in the absence of disease progression or unacceptable toxicity.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,209 Previous Clinical Trials

3,767,101 Total Patients Enrolled

83 Trials studying Breast Cancer

13,810 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,663 Previous Clinical Trials

40,925,872 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Minetta C LiuPrincipal InvestigatorMayo Clinic in Rochester

2 Previous Clinical Trials

501 Total Patients Enrolled

Media Library

Oncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating Protein (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04521764 — Phase 1

Frequently Asked Questions

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

What is the sample size of this investigation?

"Verified. Clinicaltrials.gov documents that this research endeavour, which was initially published on September 23rd 2020, is currently recruiting participants. 33 individuals are needed from a single medical facility for the study to be completed successfully."

Answered by AI

Is recruitment still open for this scientific experiment?

"Clinicaltrials.gov confirms that this trial is currently in progress, with its initial posting on September 23rd 2020 and most recent update occurring two years later."

Answered by AI

Are there any other investigations that have focused on the Oncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating Protein?

"Currently, there are 8 studies in progress looking into Oncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating Protein. 1 of those trials has advanced to Phase 3 status and is located within Rochester, Minnesota; though, 70 additional sites are conducting research on this treatment."

Answered by AI

How hazardous is the application of Oncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating Protein for people?

"Data related to the safety and efficacy of Oncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating Protein is limited, therefore our team at Power appraised its safety level as a 1."

Answered by AI

Recent research and studies

Molecular Therapy - Methods & Clinical DevelopmentJournal

Preclinical Safety Assessment of Mv-s-nap, a Novel Oncolytic Measles Virus Strain Armed with an H. Pylori Immunostimulatory Bacterial Transgene

Viker, Kimberly B., Michael B. Steele, Ianko D. Iankov, Susanna C. Concilio, Arun Ammayappan, Brad Bolon, Nathan J. Jenks, et al.. 2022. “Preclinical Safety Assessment of Mv-s-nap, a Novel Oncolytic Measles Virus Strain Armed with an H. Pylori Immunostimulatory Bacterial Transgene”. Molecular Therapy - Methods & Clinical Development. Elsevier BV. doi:10.1016/j.omtm.2022.07.014.

clinicaltrials.govStudy

A Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Breast Cancer

2020. "A Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04521764.