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Virus Therapy

Measles Virus-Based Vaccine for Breast Cancer

Phase 1

Recruiting

Led By Siddhartha Yadav, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

Age >= 18 years

Must not have

Standing requirement for blood product support

HER2 directed therapy =< 3 weeks prior to registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating the side effects and best dose of a modified measles virus, MV-s-NAP, in treating patients with metastatic breast cancer.

Who is the study for?

Adults with invasive breast cancer that has spread (metastatic) and no curative standard therapy available. Must have good organ function, acceptable blood counts, ECOG status 0-2, and a life expectancy of at least 12 weeks. Cannot be pregnant or have had certain treatments recently.

What is being tested?

The trial is testing MV-s-NAP, a modified measles virus designed to target and destroy breast cancer cells by producing an inflammatory protein called NAP. The study will determine the best dose and monitor its effects on metastatic breast cancer through various tests.

What are the potential side effects?

Potential side effects may include typical reactions to vaccines such as fever or rash, inflammation due to the immune response triggered by NAP protein production, and possible tissue damage at tumor sites where the virus is administered.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself and perform daily activities.

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I am 18 years old or older.

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There are no curative treatment options available for my condition.

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My breast cancer has spread, and its ER/PR/HER2 status is known.

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I have a cancer spot larger than 1 cm, or over 2 cm in my lungs, that can be safely treated with an injection.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need regular blood transfusions.

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I have not had HER2 therapy in the last 3 weeks.

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My cancer is causing or might soon cause serious problems by pressing on or invading into nearby organs.

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There is a known treatment for my condition that could cure me or extend my life.

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I still have side effects from my last cancer treatment.

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I have not received any viral or gene therapy before signing up.

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I am not currently on any experimental treatments.

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I have not had immunotherapy in the last 4 weeks.

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I am HIV positive or have a history of immunodeficiency.

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My cancer has spread to my brain and hasn't been treated or is getting worse.

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I haven't had chemotherapy in the last 3 weeks.

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I have had an organ transplant.

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I have a history of chronic hepatitis B or C.

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I have severe heart issues, including heart failure or irregular heartbeats.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Best tumor response

Incidence of adverse events

Maximum tolerated dose

+2 more

Secondary study objectives

Overall survival (OS)

Progression-free survival (PFS)

Tumor response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2 (multiple cycles MV-s-NAP)Experimental Treatment4 Interventions

Patients receive MV-s-NAP IT on day 1 of each cycle. Cycles repeat every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, tumor biopsy and blood sample collection throughout the study.

Group II: Cohort 1 (single treatment MV-s-NAP)Experimental Treatment5 Interventions

Patients receive MV-s-NAP IT on day 1 in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, tumor biopsy and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Biopsy

2014

Completed Phase 4

~1090