Viral Therapy In Treating Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Cancer
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: I What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 11-007350
NCT ID: NCT01846091
Sponsor Protocol Number: MC0979
About this study
This phase I trial studies the side effects and the best dose of viral therapy in treating patients with recurrent or metastatic squamous cell carcinoma of the head and neck. 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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility 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
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Scott Okuno, M.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office