Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-00811 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| MC0979 | Other Identifier | Mayo Clinic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (MV-NIS) | Experimental | Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IT on day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Correlative studies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Number of toxicity incidents defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment | Assessed by the NCI CTCAE v. 4.0. Toxicity data will be summarized for MV-NIS virus cohorts. | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of responses using Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 | Responses will be summarized separately for MV-NIS virus by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease. | Up to 2 years |
| Time to tumor progression |
| Measure | Description | Time Frame |
|---|---|---|
| Biodistribution of virally infected cells, assessed using SPECT/CT | Descriptive statistics and simple scatter plots will form the basis of presentation. Correlations with other outcome measures will be carried out by standard parametric and nonparametric correlation procedures (Pearson's and Spearman's coefficients). Prerequisite normality testing carried out via standard Shapiro-Wilk testing. Where patterns of correlation are indicated, ordinary and partial correlation coefficients (controlling for dose levels) will be calculated. Inferential testing for significant shifts in the correlative laboratory data carried out as a hypothesis-generating exercise. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Scott Okuno | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter |
| Biological |
Given IT |
|
|
The time to tumor progression will be summarized by Kaplan-Meier curve. |
| Up to 2 years |
| Up to day 28 |
| Cellular immune response | Descriptive statistics and simple scatter plots will form the basis of presentation. Correlations with other outcome measures will be carried out by standard parametric and nonparametric correlation procedures (Pearson's and Spearman's coefficients). Prerequisite normality testing carried out via standard Shapiro-Wilk testing. Where patterns of correlation are indicated, ordinary and partial correlation coefficients (controlling for dose levels) will be calculated. Inferential testing for significant shifts in the correlative laboratory data carried out as a hypothesis-generating exercise. | Up to day 28 |
| Humoral immune response | Descriptive statistics and simple scatter plots will form the basis of presentation. Correlations with other outcome measures will be carried out by standard parametric and nonparametric correlation procedures (Pearson's and Spearman's coefficients). Prerequisite normality testing carried out via standard Shapiro-Wilk testing. Where patterns of correlation are indicated, ordinary and partial correlation coefficients (controlling for dose levels) will be calculated. Inferential testing for significant shifts in the correlative laboratory data carried out as a hypothesis-generating exercise. | Up to day 28 |
| Measles virus shedding/persistence | Descriptive statistics and simple scatter plots will form the basis of presentation. Correlations with other outcome measures will be carried out by standard parametric and nonparametric correlation procedures (Pearson's and Spearman's coefficients). Prerequisite normality testing carried out via standard Shapiro-Wilk testing. Where patterns of correlation are indicated, ordinary and partial correlation coefficients (controlling for dose levels) will be calculated. Inferential testing for significant shifts in the correlative laboratory data carried out as a hypothesis-generating exercise. | Up to 3 months |
| Time course of viral gene expression | Descriptive statistics and simple scatter plots will form the basis of presentation. Correlations with other outcome measures will be carried out by standard parametric and nonparametric correlation procedures (Pearson's and Spearman's coefficients). Prerequisite normality testing carried out via standard Shapiro-Wilk testing. Where patterns of correlation are indicated, ordinary and partial correlation coefficients (controlling for dose levels) will be calculated. Inferential testing for significant shifts in the correlative laboratory data carried out as a hypothesis-generating exercise. | Up to 3 months |
| Time course of virus elimination | Descriptive statistics and simple scatter plots will form the basis of presentation. Correlations with other outcome measures will be carried out by standard parametric and nonparametric correlation procedures (Pearson's and Spearman's coefficients). Prerequisite normality testing carried out via standard Shapiro-Wilk testing. Where patterns of correlation are indicated, ordinary and partial correlation coefficients (controlling for dose levels) will be calculated. Inferential testing for significant shifts in the correlative laboratory data carried out as a hypothesis-generating exercise. | Up to 3 months |
| Viral replication | Descriptive statistics and simple scatter plots will form the basis of presentation. Correlations with other outcome measures will be carried out by standard parametric and nonparametric correlation procedures (Pearson's and Spearman's coefficients). Prerequisite normality testing carried out via standard Shapiro-Wilk testing. Where patterns of correlation are indicated, ordinary and partial correlation coefficients (controlling for dose levels) will be calculated. Inferential testing for significant shifts in the correlative laboratory data carried out as a hypothesis-generating exercise. | Up to 3 months |
| Viremia | Descriptive statistics and simple scatter plots will form the basis of presentation. Correlations with other outcome measures will be carried out by standard parametric and nonparametric correlation procedures (Pearson's and Spearman's coefficients). Prerequisite normality testing carried out via standard Shapiro-Wilk testing. Where patterns of correlation are indicated, ordinary and partial correlation coefficients (controlling for dose levels) will be calculated. Inferential testing for significant shifts in the correlative laboratory data carried out as a hypothesis-generating exercise. | Up to day 28 |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided