Cohort Study of Increasing Doses of Yttrium-90 Conjugated to Chimeric Monoclonal Antibody cG250 (^90Y-DOTA-cG250) in Patients With Advanced Renal Cancer
This was a Phase 1, open-label, dose-escalation study of yttrium-90 conjugated chimeric G250 (\^90Y-DOTA-cG250) in patients with advanced, measurable clear cell renal cell carcinoma (RCC). Study objectives were to determine the safety, targeting, and dosimetry of \^90Y-DOTA-cG250, using indium-111 conjugated chimeric G250 (\^111In-DOTA-cG250) as a surrogate, as well as to evaluate the immunogenicity of cG250.
• All patients must have had histologically proven clear cell renal carcinoma.
• Age ≥ 18 years. Children were not enrolled because clear cell renal cancer is rarely seen in children.
• All patients must have had a clinical presentation consistent with metastatic renal carcinoma.
• Patients must have had bidimensionally measurable disease by conventional imaging methods including radiography, ultrasound, CT, or other anatomic imaging modalities. Lesions seen on skeletal scintigraphy alone were not considered measurable.
• Female patients of childbearing age were required to have a negative pregnancy test carried out the day of and prior to receiving therapy, and were asked to use effective contraception during the study.
• All patients must have been ambulatory with a Karnofsky Performance Status of at least 70.
• The following laboratory results within the last 2 weeks prior to study Day 1:
‣ serum creatinine ≤ 2.0 mg/dL
⁃ serum bilirubin (total) ≤ 2.0 mg/dL
⁃ aspartate aminotransferase (AST) ≤ 2.5 × the upper limit of normal (ULN)
⁃ alanine aminotransferase (ALT) ≤ 2.5 × ULN
⁃ white blood cell (WBC) count ≥ 3500/mm\^3
⁃ platelet count ≥ 100,000/mm\^3
⁃ prothrombin time ≤ 1.3 × control
• Able and willing to give valid written informed consent.