Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
18

Inclusion Criteria

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)
Creatinine =< 1.0 mg/dL
Measurable disease
...
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)
Creatinine =< 1.0 mg/dL
Measurable disease
Willingness to provide biologic samples for correlative research purposes
Platelet (PLT) >= 100,000
Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 1.5 x ULN
Life expectancy >= 12 weeks
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
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
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Willingness to return to Mayo Clinic enrolling institution for follow-up
Hemoglobin (HgB) > 9.0 g/dL
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
Total bilirubin =< institutional upper limit of normal (ULN)
Absolute neutrophil count (ANC) >= 1500
Provide informed written consent

Exclusion Criteria

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
Requiring blood product support
History of chronic hepatitis B or C
...
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
Requiring blood product support
History of chronic hepatitis B or C
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
Active infection =< 5 days prior to registration
Receiving therapeutic anticoagulation (Coumadin or low molecular weight heparin)
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
Human immunodeficiency virus (HIV)-positive test result, or history of other immunodeficiency
Current exposure to household contacts =< 15 months old or household contact with known immunodeficiency
History of organ transplantation
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)
History of tuberculosis or history of tuberculin purified protein derivative (PPD) positivity
Willing to avoid household contacts =< 15 months old or household contact with known immunodeficiency 1 week after treatment
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
Treatment with oral/systemic corticosteroids, with the exception of topical or inhaled steroids
Central nervous system (CNS) metastases or seizure disorder
Allergy to measles vaccine or history of severe reaction to prior measles vaccination
Allergy to iodine; Note: this does not include reactions to intravenous contrast materials

Summary

Conditions
  • HER2/Neu Positive
  • Estrogen Receptor Negative
  • Estrogen Receptor Positive
  • Head and Neck Squamous Cell Carcinoma
  • HER2/Neu Negative
  • Invasive Breast Carcinoma
  • Progesterone Receptor Negative
  • Progesterone Receptor Positive
  • Recurrent Head and Neck Carcinoma
  • Stage IV Breast Cancer
  • Triple-Negative Breast Carcinoma
Type
Interventional
Phase
Phase 1
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 ...

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.

Inclusion Criteria

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)
Creatinine =< 1.0 mg/dL
Measurable disease
...
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)
Creatinine =< 1.0 mg/dL
Measurable disease
Willingness to provide biologic samples for correlative research purposes
Platelet (PLT) >= 100,000
Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 1.5 x ULN
Life expectancy >= 12 weeks
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
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
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Willingness to return to Mayo Clinic enrolling institution for follow-up
Hemoglobin (HgB) > 9.0 g/dL
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
Total bilirubin =< institutional upper limit of normal (ULN)
Absolute neutrophil count (ANC) >= 1500
Provide informed written consent

Exclusion Criteria

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
Requiring blood product support
History of chronic hepatitis B or C
...
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
Requiring blood product support
History of chronic hepatitis B or C
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
Active infection =< 5 days prior to registration
Receiving therapeutic anticoagulation (Coumadin or low molecular weight heparin)
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
Human immunodeficiency virus (HIV)-positive test result, or history of other immunodeficiency
Current exposure to household contacts =< 15 months old or household contact with known immunodeficiency
History of organ transplantation
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)
History of tuberculosis or history of tuberculin purified protein derivative (PPD) positivity
Willing to avoid household contacts =< 15 months old or household contact with known immunodeficiency 1 week after treatment
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
Treatment with oral/systemic corticosteroids, with the exception of topical or inhaled steroids
Central nervous system (CNS) metastases or seizure disorder
Allergy to measles vaccine or history of severe reaction to prior measles vaccination
Allergy to iodine; Note: this does not include reactions to intravenous contrast materials

Locations

Rochester, Minnesota, 55905
Rochester, Minnesota, 55905

Tracking Information

NCT #
NCT01846091
Collaborators
National Cancer Institute (NCI)
Investigators
  • Principal Investigator: Scott Okuno Mayo Clinic
  • Scott Okuno Mayo Clinic