Viral Therapy In Treating Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Cancer or Metastatic Breast Cancer

PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose (MTD) of intratumoral
administration of an Edmonston strain measles virus genetically engineered to express human
thyroidal sodium-iodide symporter (NIS) (oncolytic measles virus encoding thyroidal sodium
iodide symporter [MV-NIS]) in patients with recurrent/metastatic squamous cell head and neck
cancer. II. To determine the safety and toxicity of intratumoral administration of MV-NIS in
patients with recurrent/metastatic squamous cell head and neck cancer and 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. TERTIARY
OBJECTIVES: I. To determine the time course of viral gene expression and virus elimination
and biodistribution of virally infected cells at various time points after infection with
MV-NIS using single-photon emission computed tomography (SPECT)/computed tomography (CT)
imaging. II. To assess viremia, viral replication, and measles virus shedding/persistence
following intratumoral administration. III. To determine humoral and cellular immune response
to the injected virus. OUTLINE: This is a dose-escalation study. Patients receive oncolytic
measles virus encoding thyroidal sodium iodide symporter intratumorally (IT) on day 1. After
completion of study treatment, patients are followed up at 6 weeks, every 3 months for 1
year, and then every 6 months for 1 year.

Inclusion Criteria:

- Pathologically confirmed squamous cell carcinoma of the head and neck OR
pathologically confirmed invasive breast adenocarcinoma with documented estrogen
receptor (ER)/progesterone receptor (PR)/human epidermal growth factor receptor 2
(HER2) status and radiographic evidence of distant metastatic disease

- Measurable disease

- Head and neck cancer OR metastatic breast for which standard therapy is not 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; 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; ER/PR and HER2
status are defined by current American Society of Clinical Oncology (ASCO)/College of
American Pathologists (CAP) guidelines

- Patient may have more than one site of recurrence/metastatic disease but only one
lesion will be injected that is >= 1 cm in size (if in the lung, the lesion must be >=
2 cm and adjacent to the pleura in the lung)

- Absolute neutrophil count (ANC) >= 1500

- Platelet (PLT) >= 100,000

- Hemoglobin (HgB) > 9.0 g/dL

- Total bilirubin =< institutional upper limit of normal (ULN)

- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =<
1.5 x ULN

- Creatinine =< 1.0 mg/dL

- 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

- Provide informed written consent

- Willingness to return to Mayo Clinic enrolling institution for follow-up

- Willingness to provide biologic samples for correlative research purposes

- Life expectancy >= 12 weeks

Exclusion Criteria:

- Any of the following * Pregnant women * Nursing women * Men or women of childbearing
potential who are unwilling to employ adequate contraception during treatment and 8
weeks following the completion of treatment

- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
of the investigator, would make the patient inappropriate for entry into this study or
interfere significantly with the proper assessment of safety and toxicity of the
prescribed regimens

- Receiving therapeutic anticoagulation (Coumadin or low molecular weight heparin)

- Active infection =< 5 days prior to registration

- History of tuberculosis or history of tuberculin purified protein derivative (PPD)
positivity

- Any of the following prior therapies: * Chemotherapy =< 3 weeks prior to registration
* Immunotherapy =< 4 weeks prior to registration * Biologic therapy =< 4 weeks prior
to registration * Radiation therapy =< 3 weeks prior to registration

- Failure to fully recover from acute, reversible effects defined as =< grade 1 Common
Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0 of prior chemotherapy
regardless of interval since last treatment

- Requiring blood product support

- Central nervous system (CNS) metastases or seizure disorder

- 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)

- Treatment with oral/systemic corticosteroids, with the exception of topical or inhaled
steroids

- Current exposure to household contacts =< 15 months old or household contact with
known immunodeficiency

- Willing to avoid household contacts =< 15 months old or household contact with known
immunodeficiency 1 week after treatment

- Allergy to measles vaccine or history of severe reaction to prior measles vaccination

- Allergy to iodine; Note: this does not include reactions to intravenous contrast
materials