Last updated on July 2009

Four Doses of MAGE Vaccine for Patients With Squamous Cell Carcinoma of the Head and Neck


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Squamous Cell Carcinoma | Head and Neck Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    Age 18 or older.
    Biopsy proven progressive, recurrent (post-surgical, radiation therapy, chemotherapy,
    combination therapy), or metastatic SCC of the head and neck which, in the judgment
    of the attending physician, is incurable by standard treatment modalities, OR Biopsy
    proven SCC which the patient is unwilling to have treated with surgery, chemotherapy
    or radiation therapy.
    One or more of the following:
    MAGE-A3 positive tumor
    HPV 16 positive tumor.
    Laboratory values obtained ≤30days prior to registration:
    Alkaline phosphatase ≤3 x upper normal limit (UNL)
    AST ≤3 x UNL
    Creatinine ≤1.5 x UNL
    Hemoglobin ≥9.0 g/dL
    Albumin ≥3 mg/dL
    The subject must be capable of understanding the investigational nature, potential
    risks and benefits of the study and capable of providing valid informed consent.
    The subject must be willing to return to the University of Maryland Medical center
    for treatment and study-related follow up procedures including blood and tumor
    collections and completion of imaging studies as required by the protocol.
    Life expectancy 6 months or greater (in the judgment of the Medical
    Oncologist/Co-Investigator).
    Tumor that is biopsy accessible and measurable. This includes, but is not limited
    to, open biopsy, endoscopic biopsy, image guided biopsy, core biopsy and fine needle
    aspiration.

You may not be eligible for this study if the following are true:

  • ECOG performance status 3 or 4.
    Any of the following:
    Known HIV infection,
    Other circumstances (i.e. concurrent use of systemic immunosuppressants and
    immunocompromising condition) that in the opinion of the physician renders the
    patient a poor candidate for this trial.
    Patients with ANY malignant or metastatic SCC mass or lesion within the Central
    Nervous System (CNS). (e.g. intraparenchymal - brain, intracordal / spinal
    canal, bony masses or lesions with extension into the CNS parenchyma)
    Patients with ANY malignant or metastatic SCC mass or lesion or a volume of a
    mass or lesion in a location that in the judgment of the investigator may
    ignificantly impair the health of or threaten the patient's life, should an
    Inflammatory Response occur.
    Any of the following prior therapies:
    Chemotherapy < 4 weeks from the date of first vaccination
    Immunotherapy < 4 weeks from the date of first vaccination
    Biologic therapy < 4 weeks from the date of first vaccination
    Radiation therapy < 4 weeks from the date of first vaccination
    Any of the following:
    Pregnant women
    Nursing women unwilling to stop breastfeeding
    Men or women of childbearing potential who are unwilling to employ adequate
    contraception (condoms, diaphragm, birth control pills, injections, intrauterine
    device [IUD], or abstinence, etc.).
    NOTE: This study involves an investigational agent whose genotoxic, mutagenic and
    teratogenic effects on the developing fetus and newborn are unknown.
    Other concurrent chemotherapy, immunotherapy, radiotherapy, device, or any ancillary
    therapy considered investigational (utilized for a non-FDA-approved indication and in
    the context of a research investigation).
    Either of the following:
    Other active cancer requiring therapy to control the disease
    History of other malignancy (i.e. excluding disease under study) ≤3 years.
    Exceptions to the above include: adequately treated basal cell or squamous cell
    kin cancer, prostate cancer.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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