MC1733, 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

Overview

About this study

To determine the maximally tolerated dose (MTD) of intratumoral administration of an Edmonston strain measeles virus genetically engineered to express NAP (MV-s-NAP) in patients with metastatic breast cancer; to determine the safety and toxicity of on-time and serial administration of MV-s-NAP in patients with metastic breast cancer. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 18 years.
  • Pathologically confirmed invasive breast adenocarcinoma with documented ER/PR/HER2 status and radiographic evidence of distant metastatic disease.
  • Radiographic evidence of distant metastatic disease (using 7th edition AJCC criteria) with two discrete sites of measurable disease.         
  • No available standard therapy that is considered curative.
    • NOTE: 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 (including combination therapy that includes palbociclib or everolimus). Patients with HER2 positive breast cancer irrespective of ER/PR status must have received or no longer be candidates for standard HER2 directed therapy (i.e., trastuzumab, pertuzumab, trastuzumab emtansine, and lapatinib). Patients with ER/PR/HER2 negative breast cancer must have progressed through at least one prior cytotoxic regimen for advanced disease.
  • 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.
    • NOTE: In Phase I of the trial (single injection), only one lesion will be injected. In Phase II of the trial (3, Q3weekly injections), the same lesion will be injected unless the interventional radiologist determines that lesion is not amenable to re-injection, in which case another lesion (if present and measuring > 1 cm in greatest dimension [> 2 cm for lung lesions]) will be injected.   
  • The following laboratory values obtained < 7 days prior to registration:
    • ANC ≥ 1500/mL;
    • PLT ≥ 100,000/mL;
    • Total bilirubin ≤ institutional upper limit of normal;
    • AST ≤ 2 x ULN;
    • Creatinine ≤ 1.5 x ULN;
    • Hgb ≥ 9.0 g/dL.
  • Negative pregnancy test done ≤ 7 days prior to registration (for women of childbearing potential only).
  • 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) 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 tuberculosis or history of tuberculin skin test positivity.
  • 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 SVT).
  • Untreated or progressive 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.
  • 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-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.
  • 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.”

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Minetta Liu, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20502718

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