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Protocol No. UW19041

Principal Investigator Bruce, Justine

Phase I

Age Group Adult

Scope Local

Sponsor Type Externally Peer-Reviewed; Industry; Institutional

Title Therapeutic Combination of CLR 131 with External Beam Radiation in Head and Neck Cancer

Objective We want to find out if CLR 131 combined with radiation therapy (external beam radiation therapy or EBRT) is safe to use for recurrent head and neck cancer, to find a safe dose to use in future studies, and to find out what side effects CLR 131 has in people with recurrent head and neck cancer. CLR 131 is an investigational drug. This means that the US Food and Drug Administration (FDA) has not approved CLR 131 for the treatment of recurrent head and neck cancer, and CLR 131 can only be given in a research study

Treatment
  • You will receive 2 doses of CLR 131 given intravenously, about 1 week apart. CLR 131 is a radioactive agent. You may need to stay overnight in a leadshielded room for up to 3 days for your safety and to protect others from the radiation you emit. You will keep taking potassium iodide every day until 2 weeks after the last dose of CLR 131
  • External beam radiation therapy (EBRT). The EBRT will begin about 2-3 weeks after the last CLR 131 treatment. Your treating physician will tell you how many EBRT treatments you will need

  • Description Phase I study with combined treatment of CLR 131 with Radiation for Head and Neck Cancer

    Key Eligibility
  • Histologically or cytologically confirmed solid malignancy that has recurred in the head and neck (above the clavicles) region, e.g., subjects with recurrent cutaneous squamous cell carcinoma, salivary gland tumors or esthesioneuroblastoma are eligible for this clinical trial
  • 18 years of age or older
  • Must have undergone previous curative intent therapy, with radiation as a primary or adjuvant therapy
  • May have distant metastatic disease, as long as the locoregional site of recurrence is deemed eligible for radiation therapy, and treatment of the loco-regional disease is deemed as taking precedence over treatment of the remaining systemic disease
  • Must have at least one evaluable (measurable or non-measurable) recurrent lesion that is amenable to radiation therapy
  • Must demonstrate uptake of CLR 131 via SPECT/CT imaging, as determined by the study radiologist, in the specified site of recurrent/metastatic disease that is to be treated with radiation therapy
  • ECOG Performance status 0-1
  • Adequate hematologic, renal and hepatic function as defined by the protocol
  • Can not be pregnant or breastfeeding
  • Male and Female of child bearing potential must agree to adequate birth control as defined by the protocol
    EXCLUSION
  • Thyroid cancer
  • Other concurrent severe and/or uncontrolled concomitant medical or psychiatric conditions
  • Any ongoing or active infection, including active tuberculosis, hepatitis B or C, or known infection with the human immunodeficiency virus (HIV)
  • History of or concurrent second primary malignancy (stage III or IV) within 5 years to study enrollment
  • History of or concurrent second primary malignancy (stage I or II) that have been treated within 2 years of study enrollment
  • Subjects that have had total body or hemibody irradiation, or have had prior systemic radioisotope therapy (except for benign thyroid disease)
  • Poor venous access and will be unable to receive study drug into a peripheral venous catheter
  • Extradural tumor in contact with the spinal cord or tumor located where swelling in response to therapy may impinge upon the spinal cord
  • Serious or non-healing wound, ulcer, or bone fracture
  • History of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study entry
  • History of myocardial infarction, ventricular arrhythmia, stable/unstable angina,symptomatic congestive heart failure, coronary/peripheral artery bypass graft or stenting or other significant cardiac disease within 6 months prior to study entry
  • QT interval corrected for heart rate using Fridericia's formula (QTcF) greater than or equal to 480 ms
  • Any condition requiring the use of immunosuppression, excluding rheumatologic conditions treated with stable doses of corticosteroids (equivalent to less than or equal to prednisone 10 mg daily)
  • Ongoing hemodialysis or peritoneal dialysis
  • Poorly controlled severe COPD
  • Uncontrolled hypothyroidism or hyperthyroidism
  • Any medical condition that predisposes the subject to uncontrolled bleeding such as hemophilia, factor deficiencies, severe liver disease, or von Willebrand disease
  • Recurrent tumor recommended for surgical resection based on multidisciplinary Head and Neck Oncology Tumor Board Review

  • Applicable Disease Sites Head and Neck

    Status Open

    Participating Institutions UW Hospital and Clinics