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

NCT01846091 | Completed Phase 1

• 2 other identifiers: MC0979NCI-2013-00811
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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; Recurrent Head and Neck Carcinoma; Stage IV Breast Cancer; Triple-Negative Breast Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Number of responses using Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1

  Up to 2 years

• Time to tumor progression

  Up to 2 years

Other Outcomes (8)

• Biodistribution of virally infected cells, assessed using SPECT/CT

  Up to day 28

• Cellular immune response

  Up to day 28

• Humoral immune response

  Up to day 28

Study Arms (1)

Treatment (MV-NIS)

EXPERIMENTAL

Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IT on day 1.

Other: Laboratory Biomarker Analysis; Biological: Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (MV-NIS)

Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter BIOLOGICAL

Given IT

Also known as: MV-NIS

Treatment (MV-NIS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed squamous cell carcinoma of the head and neck OR pathologically confirmed invasive breast adenocarcinoma with documented estrogen receptor (ER)/progesterone receptor (PR)/human epidermal growth factor receptor 2 (HER2) status and radiographic evidence of distant metastatic disease
• Measurable disease
• Head and neck cancer OR metastatic breast for which standard therapy is not curative \*NOTE: Patients with ER/PR positive, HER2 negative breast cancer must have progressed through at least one prior cytotoxic regimen for advanced disease and no longer be candidates for standard endocrine therapy; patients with HER2 positive breast cancer irrespective of ER/PR status must have received or no longer be candidates for standard HER2 directed therapy (i.e., trastuzumab, pertuzumab, trastuzumab emtansine, and lapatinib); patients with ER/PR/HER2 negative breast cancer must have progressed through at least one prior cytotoxic regimen for advanced disease; ER/PR and HER2 status are defined by current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
• Patient may have more than one site of recurrence/metastatic disease but only one lesion will be injected that is \>= 1 cm in size (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 ULN
• Creatinine =\< 1.0 mg/dL
• 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 enrolling institution for follow-up
• Willingness to provide biologic samples for correlative research purposes

You may not qualify if:

• 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)
• Active infection =\< 5 days prior to registration
• History of tuberculosis or history of tuberculin 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
• Requiring blood product support
• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Breast Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Scott Okuno

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: May 3, 2013
• Study Start: April 9, 2013
• Primary Completion: September 18, 2019
• Study Completion: November 26, 2019
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

US (1)