Vaccine Therapy in Treating Patients With Malignant Peripheral Nerve Sheath Tumor That is Recurrent or Cannot Be Removed by Surgery

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) of intratumoral administration of an
Edmonston strain measles virus genetically engineered to express neurofibromatosis type 1
(NIS) (oncolytic measles virus encoding thyroidal sodium iodide symporter [MV-NIS]) in
patients with inoperable or recurrent malignant peripheral nerve sheath tumor (MPNST).

II. To determine the safety and toxicity of intratumoral administration of MV-NIS in patients
with inoperable recurrent MPNST.

III. To preliminarily assess antitumor efficacy of intratumoral MV-NIS administration by the
rate of progression-free survival at 3 months, achieved by following radiographic response of
the treated lesion using World Health Organization (WHO) response criteria guidelines.

SECONDARY 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. IV. To assess
the quality-of-life of patients treated with MV-NIS, using two inventories (Pain and
Fatigue).

V. To assess time to progression and differences in growth rates between treated and
untreated tumor lesions.

VI. To assess the overall survival time of patients treated with MV-NIS.

OUTLINE:

Patients receive MV-NIS intratumorally on day 1. Patients also undergo SPECT/CT at baseline
and at 3 and 8 days after MV-NIS. Patients may also undergo SPECT/CT at 15 and 28 days, and
at 6 weeks based on whether there is uptake on prior imaging studies.

After completion of study treatment, patients are followed up at 3, 6, 12, 18, and 24 months.

Inclusion Criteria:

- Pathologically confirmed MPNST, with or without underlying diagnosis of
neurofibromatosis type 1 (diagnostic criteria for neurofibromatosis type 1)

- Measurable disease as defined by at least one tumor that is measurable in two
dimensions on CT or magnetic resonance imaging (MRI) scan (minimum size 1.0 cm for at
least one lesion)

- MPNST for which standard therapy is not curative, including patients with surgically
unresectable lesions, progression (WHO criteria) or recurrence of an MPNST in a
previously radiated field (if it has been at least 4 weeks prior to registration since
the last dose of radiation); Note: patients with metastatic disease also are eligible
for participation

- Patient may have more than one site of recurrent or metastatic disease but only one
lesion that is >= 1 cm in size will be injected (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 upper limit of normal (ULN)

- Creatinine =< 1.0 mg/dL

- International normalized ratio (INR) =< 2.0

- 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 Rochester for follow-up

- Willingness to provide biologic samples for correlative research purposes

- Life expectancy >= 12 weeks

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

- Ability to complete questionnaire(s) by themselves or with assistance

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,
heparin, apixaban, dabigatran, rivaroxaban, warfarin)

- Active infection =< 5 days prior to registration

- History of tuberculosis or history of 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 except alopecia and neuropathy

- Requiring blood product support

- Patient has 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; NOTE: patient must avoid contact during documented viral
shedding; participants with continuous viral shedding will be given recommendations
for restricted activities to avoid contact with immunocompromised persons

- 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

- Allergy to lidocaine, fentanyl, midazolam, or propofol (may be used during tumor
biopsy or injection)