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
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.
SECONDARY OBJECTIVES:
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.
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 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.
Interventional
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
4 weeks
Yes
Scott Okuno
Principal Investigator
Mayo Clinic
United States: Food and Drug Administration
MC0979
NCT01846091
April 2013
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |