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

Anatomic Stage IV Breast Cancer AJCC v8 Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Anatomic Stage IV Breast Cancer AJCC v8
• Breast Neoplasms
• Carcinoma
• Invasive Breast Carcinoma
• Metastatic Breast Adenocarcinoma
• Recurrent Breast Carcinoma

• NCT number: NCT04521764
• Study type: Interventional
• Source: Mayo Clinic
• Status: Recruiting
• Phase: Phase 1
• Start date: September 23, 2020
• Completion date: August 15, 2027