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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:
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 or Metastatic Breast Cancer

Status Completed

Clinical Trial Summary

This phase I trial studies the side effects and the best dose of viral therapy in treating patients with squamous cell carcinoma of the head and neck that has returned (come back) after a period of improvement or has spread to other parts of the body or breast cancer that has spread to other parts of the body. A virus called encoding thyroidal sodium iodide symporter, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Breast Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Estrogen Receptor Negative
Estrogen Receptor Positive
Head and Neck Squamous Cell Carcinoma
HER2/Neu Negative
HER2/Neu Positive
Invasive Breast Carcinoma
Progesterone Receptor Negative
Progesterone Receptor Positive
Recurrence
Recurrent Head and Neck Carcinoma
Squamous Cell Carcinoma of Head and Neck
Stage IV Breast Cancer
Triple-Negative Breast Carcinoma

Clinical Trial Details

NCT number	NCT01846091
Study type	Interventional
Source	Mayo Clinic
Contact
Status	Completed
Phase	Phase 1
Start date	April 9, 2013
Completion date	November 26, 2019

View Details

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