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
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
I. To determine the safety and toxicity of intratumoral administration of MV-NIS in patients
with recurrent/metastatic squamous cell head and neck cancer.
II. To assess in a preliminary fashion antitumor efficacy of this approach by following,
radiographic response, and time to progression.
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
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 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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) as assessed by the National Cancer (NCI) CTCAE v. 4.0
United States: Food and Drug Administration
|Mayo Clinic||Rochester, Minnesota 55905|