Pilot Trial To Evaluate The Utility Of 124I-cG250 for The Early Detection Of Response to Therapy In Patients With Metastatic Renal Cell Carcinoma
- Histologically confirmed clear cell carcinoma (conventional) with advanced and/or
- Radiographic evidence of unidimensionally measurable disease with at least one lesion
≥2.0 cm in diameter on 16-slice multi-detector CT scan of the chest, abdomen, and
pelvis. 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 sunitinib or
- Male or female, 18 years of age or older.
- ECOG (Eastern Cooperative Oncology Group) performance status of ≤ 2.
- Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, or
surgical procedure to NCI CTCAE grade ≤2.
- The following laboratory results should be within the following limits, within 2
weeks prior to study start:
- Absolute neutrophil count (ANC) ≥1.5 x 109/L
- Total serum bilirubin <2.0 mg/dL
- Platelets ≥100,000/μL
- Serum creatinine ≤2.0 mg/dL
- Aspartate aminotransaminase (AST) ≤ 2.5 x ULN (≤ 5.0x in case of liver mets)
- Alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5.0x in case of liver mets)
- Valid written informed consent signed by the patient prior to any study-specific
- 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 sunitinib or pazopanib within the past 4 weeks or at any time of
greater than 6 weeks duration.
- Patient is unable to undergo contrast-enhanced CT.
- Uncontrolled or unstable hyperthyroidism or Grave's Disease.
- Contraindication to IOSATTM intake (see package insert).
- Contraindication to sunitinib or pazopanib treatment.
- 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.