An Oncolytic Measles Virus (MV-s-NAP) for the Treatment of Patients With Metastatic Breast Cancer

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PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose (MTD) of intratumoral administration of an Edmonston strain measles virus genetically engineered to express NAP (oncolytic measles virus encoding helicobacter pylori neutrophil-activating protein (modified virus strain neutrophil activ...

PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose (MTD) of intratumoral administration of an Edmonston strain measles virus genetically engineered to express NAP (oncolytic measles virus encoding helicobacter pylori neutrophil-activating protein (modified virus strain neutrophil activating protein [MV-s- NAP) in patients with metastatic breast cancer. II. To determine the safety and toxicity of one-time intratumoral administration of MV-s-NAP in patients with metastatic breast cancer. III. To determine the safety and toxicity of serial intratumoral administration of MV-s-NAP in patients with metastatic breast cancer. SECONDARY OBJECTIVES: I. To assess in a preliminary fashion antitumor efficacy of this approach by following radiographic response and time to progression. Ia. Response at and away from the site of MV-s-NAP administration will be evaluated. CORRELATIVE OBJECTIVES: I. To assess viremia, viral replication, and measles virus shedding/persistence following intratumoral administration. II. To determine the time course of viral infection and viral gene expression in treated/untreated lesions. III. To determine immune response development against MV, the therapeutic s-NAP transgene, and the tumor. IV. To obtain preliminary assessments of PD-L1 expression in tumor cells and tumor infiltrating lymphocytes (TILs). OUTLINE: Patients receive MV-s-NAP intratumorally (IT) on day 1 in the absence of disease progression or unacceptable toxicity. After 1 cycle of treatment, patients who experience disease progression proceed to follow-up. Patients who achieve complete response (CR), partial response (PR), or stable disease (SD) receive MV-s-NAP IT every 21 days for up to 3 additional cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months during year 1, and then every 6 months during year 2.

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