RecruitingPhase 1NCT04521764

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

Phase I Trial of Intratumoral Administration of a Measles Virus Derivative Expressing the Helicobacter Pylori Neutrophil-Activating Protein (NAP) (MV-s-NAP) in Patients With Metastatic Breast Cancer

Sponsor

Mayo Clinic

Enrollment

54 participants

Start Date

Sep 23, 2020

Study Type

INTERVENTIONAL

Conditions

Anatomic Stage IV Breast Cancer AJCC v8 Recurrent Breast Carcinoma Invasive Breast Carcinoma Stage IV Breast Cancer AJCC v6 and v7 Metastatic Breast Adenocarcinoma

Summary

This phase I trial investigates the side effects and best dose of using a modified measles virus, MV-s-NAP, in treating patients with invasive breast cancer that has spread to other places in the body (metastatic). Both the unmodified vaccination measles virus (MV-Edm) and this modified virus (MV-s-NAP) have been shown to multiply in and destroy breast cancer cells in the test tube and in research mice. MV-s-NAP has been altered by having an extra gene (piece of deoxyribonucleic acid \[DNA\]) so that virus can make a protein called helicobacter pylori neutrophil activating protein (NAP) which is normally expressed in inflammatory reactions. Monitoring blood, urine, tissue, and throat swab samples, and using imaging tests may help to determine whether MV-s-NAP has any impact on the amount of disease present in metastatic breast cancer patients.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental cancer vaccine (MV-s-NAP) made from a modified measles virus in people with metastatic breast cancer, to see if it can help the immune system fight the cancer. **You may be eligible if...** - You are 18 or older - You have been diagnosed with breast cancer that has spread to distant parts of the body (metastatic) - Your cancer has been tested for hormone receptors and HER2 - You have already received standard treatments for metastatic breast cancer **You may NOT be eligible if...** - You have untreated cancer in the brain or spinal cord - You have significant immune system problems or are on immune-suppressing medications - You have active serious infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALOncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating Protein

Given IT

PROCEDUREComputed Tomography

Undergo CT scan

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREBiopsy

Undergo tumor biopsy

PROCEDUREBiospecimen Collection

Undergo blood and urine sample collection

Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT04521764

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