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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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 criteria

Qualifiers

Age >= 18 years

COHORT 1 ONLY: Pathologically confirmed invasive breast adenocarcinoma with documented estrogen receptor (ER)/progesterone receptor (PR) /HER2 status and radiographic evidence of distant metastatic disease

COHORTS 2 & 3 ONLY: Pathologically confirmed invasive breast adenocarcinoma with documented ER/PR/HER2 status and radiographic evidence of distant metastatic or recurrent disease

COHORT 1 ONLY: Radiographic evidence of distant metastatic disease (using 7th edition American Joint Committee on Cancer [AJCC] criteria) with two discrete sites of measurable disease

Disqualifiers

Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy

Clinical or radiographic suspicion of impending visceral crisis due to invasion or compression by tumor

Active infection =< 5 days prior to registration

History of other malignancy =< 5 years except for non-melanoma skin cancer or carcinoma in situ of the cervix

Trial design

Treatments tested in this trial

  • Oncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating Protein
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Biopsy
  • Biospecimen Collection

Treatment groups

54 Participants
are divided into 3 treatment groups

Sponsors and collaborators