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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT04521764
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating Protein — BIOLOGICAL
    Given IT
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Biopsy — PROCEDURE
    Undergo tumor biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood and urine sample collection

Study Details

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.

Key Dates

Start date
Sep 23, 2020
Status verified
Jan 2026
Primary completion
Aug 15, 2027
Completion
Aug 15, 2027

Study Design

Enrollment
54 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 (single treatment MV-s-NAP)
    Patients receive MV-s-NAP IT on day 1 in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, tumor biopsy, and blood and urine sample collection throughout the study.
  • Experimental: Cohort 2 (Every 21 day MV-s-NAP)
    Patients receive MV-s-NAP IT on day 1 of each cycle. Cycles repeat every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, tumor biopsy, and blood and urine sample collection throughout the study. (CLOSED TO ACCRUAL 6/9/2025)
  • Experimental: Cohort 3 (Every 14 day MV-s-NAP)
    Patients receive MV-s-NAP IT on day 1 of each cycle. Cycles repeat every 14 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, tumor biopsy and blood and urine sample collection throughout the study.

Primary Outcome Measure

Maximum tolerated dose [ Time Frame: During the first cycle of treatment (each cycle = 21 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Siddhartha Yadav, MD (PRINCIPAL_INVESTIGATOR)

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