Phase I Trial of Intratumoral Administration of a NIS-Expressing Derivative Manufactured From a Genetically Engineered Strain of Measles Virus in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Inclusion Criteria:

- Pathologically confirmed squamous cell carcinoma of the head and neck

- Measurable disease

- Head and neck cancer for which standard therapy is not curative

- 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

- Must have anti-measles immunity as demonstrated by serum immunoglobulin G (IgG)
anti-measles antibody levels of >= 20.0 EU/ml as determined by enzyme immunoassay
(Diamedix, FL)

- Cluster of differentiation (CD) 4 count >= 200/uL or >= 15% of peripheral blood
lymphocytes

Exclusion Criteria:

- Any of the following because this study involves an agent that has known genotoxic,
mutagenic and teratogenic effects

- 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