RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Urine samples, MRI scans, CT scans, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients undergo computed tomography (CT) scan, magnetic resonance imaging (MRI), tumor biopsy and blood and urine sample collection throughout the study."
  • "Patients undergo CT scan, MRI, tumor biopsy and blood and urine sample collection throughout the study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early-stage study tests the side effects and best dose of MV-s-NAP, a vaccine made from a changed measles virus. It is for adults with breast cancer that has spread or, in some study groups, has come back. Tests and scans will help show whether it affects the cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older, with breast cancer confirmed by tissue testing and known hormone receptor and HER2 results.
  • Have cancer seen on scans: group 1 needs cancer that has spread and two areas that can be measured; groups 2 and 3 need cancer that has spread or returned and at least one area that can be measured.
  • Have at least one tumor wider than 1 cm, or wider than 2 cm if in the lung. In group 1, the tumor must be safe to inject through the skin.
  • Meet prior treatment rules based on your cancer type. These include cancer worsening after chemotherapy, prior HER2 treatment, or no longer being able to use certain standard treatments.
  • Meet blood count, liver, and kidney test limits. If you could become pregnant, have a negative pregnancy test within 7 days before signing up.
  • Be able to care for yourself and be out of bed at least half the day. Be expected to live at least 12 weeks.
  • Be able to give written consent to join.
  • Agree to return to the Mayo Clinic study site for follow-up and give samples for research.

Who can't join

  • Have a standard treatment available that could cure the cancer or clearly help you live longer, or have a tumor threatening serious organ problems.
  • Have an active infection within 5 days before signing up, or another cancer within 5 years, except certain skin cancers or very early cervical cancer.
  • Had chemotherapy or HER2 treatment within 3 weeks, immune treatment or an experimental drug within 4 weeks, or targeted treatment within 2 weeks. Any past virus or gene therapy also rules you out.
  • Have not fully recovered from short-term effects of past cancer treatment, or are getting other cancer treatment, experimental treatment, or medicines that could interfere with the study. Most steroid pills or injections are not allowed, with limited exceptions.
  • Have serious heart disease, certain abnormal heart rhythms, or untreated or worsening cancer in the brain or spinal cord. Treated brain cancer spread must cause no symptoms and have stable MRI scans for 3 months, including a scan within 28 days of entry.
  • Need ongoing blood transfusions, have HIV or another weakened immune system, have had an organ transplant, or have long-term hepatitis B or C.
  • Have household contact with a child age 15 months or younger or someone with a weakened immune system.
  • Have a measles vaccine allergy or past severe reaction, or received the killed measles vaccine in 1963–1967 without later getting two live vaccine doses.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 * COHORTS 2 \& 3 ONLY: Radiographic evidence of distant metastatic or recurrent disease (using 8th edition AJCC criteria) with at least one site of measurable disease * Prior therapies: * Patients with ER/PR positive, HER2 negative breast cancer must have progressed through at least one prior cytotoxic regimen for advanced disease and no longer be candidates for standard endocrine therapy or combination of endocrine therapy with other agents such as CDK4/6 inhibitors * Patients with HER2 positive breast cancer irrespective of ER/PR status must have received or no longer be candidates for HER2 directed therapy with trastuzumab or pertuzumab * Patients with ER/PR/HER2 negative breast cancer must have progressed through at least one prior cytotoxic regimen for advanced disease * COHORT 1: At least one site of recurrent/metastatic disease that measures \> 1 cm in greatest dimension (\> 2 cm for lung lesions) and is amenable to safe percutaneous intratumoral administration of MV-s-NAP as determined by an interventional radiologist * COHORTS 2 \& 3 ONLY: At least 1 site of recurrent/metastatic disease measuring \> 1 cm in greatest dimension \[\> 2 cm for lung lesions\] (Note that if the lesion injected in cycle 1 is not amenable to re-injection, another lesion could be selected for injection * Absolute neutrophil count (ANC) \>= 1500/uL (=\< 7 days prior to registration) * Platelets (PLT \>= 100,000/uL) (=\< 7 days prior to registration) * Total bilirubin =\< institutional upper limit of normal (=\< 7 days prior to registration) * Aspartate aminotransferase (AST) =\< 2 x upper limit of normal (ULN) (=\< 7 days prior to registration) * Creatinine =\< 1.5 x ULN (=\< 7 days prior to registration) * Hemoglobin \>= 9.0 g/dL (=\< 7 days prior to registration) * Negative pregnancy test done =\< 7 days prior to registration (for women of childbearing potential only) * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 * Ability to provide informed written consent * Willingness to return to the Mayo Clinic enrolling institution for follow-up * Willingness to provide biologic samples for correlative research purposes * Life expectancy \>= 12 weeks * Concomitant administration of a bone modifying agent (e.g., zoledronic acid or denosumab) is permitted for the prevention or management of skeletal related events in patients with bone metastases and documentation of tolerability with prior exposures Exclusion Criteria: * 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 * Any of the following prior therapies: * Chemotherapy =\< 3 weeks prior to registration * Immunotherapy =\< 4 weeks prior to registration * HER2 directed therapy =\< 3 weeks prior to registration * Targeted therapy =\< 2 weeks prior to registration (e.g., CDK4/6 inhibitors, everolimus) * Investigational agent =\< 4 weeks prior to registration * Any viral or gene therapy prior to registration * Failure to fully recover from acute, reversible effects of prior systemic therapy regardless of interval since last treatment * New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias (atrial fibrillation or supraventricular tachycardia \[SVT\]) * Untreated or progressive central nervous system (CNS) metastases * NOTE: Patients with a history of treated brain metastases (surgical resection, whole brain radiation, and/or stereotactic radiosurgery) are eligible only if they are asymptomatic and have stable MRI scans for 3 consecutive months, including \< 28 days of study entry * Standing requirement for blood product support * Human immunodeficiency virus (HIV) positive test result or history of other immunodeficiency * History of organ transplantation * History of chronic hepatitis B or C * Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration \[FDA\]-approved indication and in the context of a research investigation) * Any concurrent medications that the principal investigator determines could interfere with the trial * Treatment with oral/systemic corticosteroids, with the exception of topical or inhaled steroids or low dose systemic steroids for physiologic replacement (e.g., Prednisone ≤10 mg/day) * Exposure to household contacts =\< 15 months old or household contact with known immunodeficiency * Allergy to measles vaccine or history of severe reaction to prior measles vaccination * History of receiving the measles vaccination with the "killed vaccine" between 1963-1967 without subsequent re-immunization (2 doses) with the active, live vaccination."

Study sites (1)

MN