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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, Recurrent Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Salivary Gland Cancer, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Nasopharynx, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Recurrent Verrucous Carcinoma of the Larynx, Recurrent Verrucous Carcinoma of the Oral Cavity, Salivary Gland Squamous Cell Carcinoma, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Stage IVA Salivary Gland Cancer, Stage IVA Squamous Cell Carcinoma of the Larynx, Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVA Verrucous Carcinoma of the Larynx, Stage IVA Verrucous Carcinoma of the Oral Cavity, Stage IVB Salivary Gland Cancer, Stage IVB Squamous Cell Carcinoma of the Larynx, Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Oropharynx, Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVB Verrucous Carcinoma of the Larynx, Stage IVB Verrucous Carcinoma of the Oral Cavity, Stage IVC Salivary Gland Cancer, Stage IVC Squamous Cell Carcinoma of the Larynx, Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVC Squamous Cell Carcinoma of the Oropharynx, Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVC Verrucous Carcinoma of the Larynx, Stage IVC Verrucous Carcinoma of the Oral Cavity, Tongue Cancer

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Trial Information

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.


Inclusion Criteria:



- Pathologically confirmed squamous cell carcinoma of the head and neck

- Measurable disease

- Head and neck cancer for which standard therapy is not curative

- 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

- Life expectancy >= 12 weeks

- Must have anti-measles immunity as demonstrated by serum immunoglobulin G (IgG)
anti-measles antibody levels of >= 20.0 EU/ml as determined by enzyme immunoassay
(Diamedix, FL)

- Cluster of differentiation (CD) 4 count >= 200/uL or >= 15% of peripheral blood
lymphocytes

Exclusion Criteria:

- Any of the following because this study involves an agent that has known genotoxic,
mutagenic and teratogenic effects

- 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

- Willing to avoid household contacts =< 15 months old or household contact with known
immunodeficiency 1 week after treatment

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

4 weeks

Safety Issue:

Yes

Principal Investigator

Scott Okuno

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

MC0979

NCT ID:

NCT01846091

Start Date:

April 2013

Completion Date:

Related Keywords:

  • Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
  • Recurrent Metastatic Squamous Neck Cancer With Occult Primary
  • Recurrent Salivary Gland Cancer
  • Recurrent Squamous Cell Carcinoma of the Hypopharynx
  • Recurrent Squamous Cell Carcinoma of the Larynx
  • Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Recurrent Squamous Cell Carcinoma of the Nasopharynx
  • Recurrent Squamous Cell Carcinoma of the Oropharynx
  • Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Recurrent Verrucous Carcinoma of the Larynx
  • Recurrent Verrucous Carcinoma of the Oral Cavity
  • Salivary Gland Squamous Cell Carcinoma
  • Stage IV Squamous Cell Carcinoma of the Hypopharynx
  • Stage IV Squamous Cell Carcinoma of the Nasopharynx
  • Stage IVA Salivary Gland Cancer
  • Stage IVA Squamous Cell Carcinoma of the Larynx
  • Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IVA Squamous Cell Carcinoma of the Oropharynx
  • Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Stage IVA Verrucous Carcinoma of the Larynx
  • Stage IVA Verrucous Carcinoma of the Oral Cavity
  • Stage IVB Salivary Gland Cancer
  • Stage IVB Squamous Cell Carcinoma of the Larynx
  • Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IVB Squamous Cell Carcinoma of the Oropharynx
  • Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Stage IVB Verrucous Carcinoma of the Larynx
  • Stage IVB Verrucous Carcinoma of the Oral Cavity
  • Stage IVC Salivary Gland Cancer
  • Stage IVC Squamous Cell Carcinoma of the Larynx
  • Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IVC Squamous Cell Carcinoma of the Oropharynx
  • Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Stage IVC Verrucous Carcinoma of the Larynx
  • Stage IVC Verrucous Carcinoma of the Oral Cavity
  • Tongue Cancer
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Laryngeal Diseases
  • Tongue Neoplasms
  • Carcinoma, Verrucous
  • Neoplasms, Unknown Primary
  • Salivary Gland Neoplasms
  • Hypopharyngeal Neoplasms
  • Laryngeal Neoplasms
  • Paranasal Sinus Neoplasms
  • Oropharyngeal Neoplasms
  • Nasopharyngeal Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905