124I-cG250 PET/CT in Early Detection of Response to Therapy in Patients with Advanced or Metastatic Kidney Cancer

Inclusion Criteria

• Histologically confirmed clear cell carcinoma (conventional) with advanced and/or metastatic disease
• Radiographic evidence of unidimensionally measurable disease; lesions will be considered measurable or non-measurable as per definitions provided in RECIST version 1.1
• Subjects must be planned for treatment with approved treatment doses of a VEGF receptor TKI (e.g., sunitinib, pazopanib, cabozantinib, axitinib, sorafenib, lenvatinib)
• Male or female, 18 years of age or older
• Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
• Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, or surgical procedure to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade =< 2
• Absolute neutrophil count (ANC) >= 1.5 x 10^9/L, within 2 weeks prior to study start
• Total serum bilirubin < 2.0 mg/dL, within 2 weeks prior to study start
• Platelets >= 100,000/L, within 2 weeks prior to study start
• Serum creatinine =< 2.0 mg/dL, within 2 weeks prior to study start
• Aspartate aminotransaminase (AST) =< 2.5 x upper limit of normal (ULN) (=< 5.0 x in case of liver [metastases] mets), within 2 weeks prior to study start
• Alanine aminotransferase (ALT) =< 2.5 x ULN (=< 5.0 x in case of liver mets), within 2 weeks prior to study start
• Valid written informed consent signed by the patient prior to any study-specific procedures

Exclusion Criteria

• Women who are pregnant or breast-feeding; female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy; a negative pregnancy test is required within 24 hours of administration of radiotracer and study initiation for women of childbearing age and potential
• Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study
• Prior treatment with a VEGF receptor TKI within a time period equivalent to 5 half-lives of the prior TKI (e.g., there should be no substantial amount of TKI remaining in the patient)
• Patient is unable to undergo contrast-enhanced CT
• Uncontrolled or unstable hyperthyroidism or Grave’s disease
• Contraindication to potassium iodide
• Uncontrolled active seizure disorder or history of cerebrovascular accident (CVA) or transient ischemic (TI) attack within the past 12 months
• Unstable cardiac disease, e.g., unstable angina, congestive heart failure or myocardial infarction within the preceding 6 months
• Known active hepatitis B/C or HIV (human immunodeficiency virus) infection
• Prior exposure to murine proteins or chimeric antibodies