CLR 131 Combined With Radiation for Head and Neck Cancer

Inclusion Criteria

• Participant must be informed of the investigational nature of the study and must be able to sign a written informed consent.
• Participants with histologically or cytologically confirmed solid malignancy that has recurred in the head and neck (above the clavicles) region, e.g., participants with recurrent cutaneous squamous cell carcinoma, salivary gland tumors or esthesioneuroblastoma are eligible for this clinical trial.
• Participants must have undergone previous curative intent therapy, with radiation as a primary or adjuvant therapy.
• Participants 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.
• Participants must have at least one evaluable (measurable or non-measurable) recurrent lesion that is amenable to radiation therapy.
• Participants 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. There is a subset of up to 6 patients who may continue with CLR 131 treatment without uptake on the SPECT/CT scan after the test dose.
• Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
• Participants must have a life expectancy of at least 6 months.
• The participant has adequate hematologic function, as evidenced by:
• an absolute neutrophil count (ANC) ≥ 1500 / µL
• hemoglobin ≥9 g/dL (5.58 mmol/L)
• and platelets ≥100,000 / µL
• If full-dose anticoagulation therapy is used, platelets ≥ 150,000 / µL are required.
• If participant is on full-dose anticoagulation therapy, the anticoagulation therapy must be reversible, and reversal of the anticoagulation therapy must not be life-threatening, as judged by the investigator.
• The participant has adequate renal function as defined by:
• serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or Cockcroft-Gault calculated creatinine clearance >/= 60 ml/min
• The participant has adequate hepatic function as defined by:
• total bilirubin ≤ 1.5 mg/dL (25.65 μmol/L)
• aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 times the ULN
• Women of childbearing potential (WOCP) have a confirmed negative urine pregnancy test within 24 hours prior to test dose of CLR 131.
• Participants must use a medically acceptable method of birth control such as an oral, implantable, injectable, or transdermal hormonal contraceptive, an intrauterine device (IUD), a double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream), or total abstinence during the study participation and for 6 months after last dose of study drug. Women who are postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) are not considered to be WOCP.
• Men who are not surgically or medically sterile agree to use an acceptable method of contraception. Male participants with female sexual partners who are pregnant, possibly pregnant, or who could become pregnant during the study must abstain from intercourse for three weeks after each CLR 131 dose and agree to use condoms at least 6 months after the last dose of study drug. Total abstinence for the same study period is an acceptable alternative.

Exclusion Criteria

• Recurrent tumor recommended for surgical resection based on multidisciplinary Head and Neck Oncology Tumor Board Review
• Thyroid cancer
• Known hypersensitivity to iodine
• Other concurrent severe and/or uncontrolled concomitant medical or psychiatric conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol, per investigator discretion
• Chemotherapy or major surgery within 4 weeks