Phase I/II Study of 131-I-Labeled Chimeric Antibody G250 (131-I-cG250) in Patients With Advanced Renal Carcinoma

Trial Information

Phase I/II Study of 131-I-Labeled Chimeric Antibody G250 (131-I-cG250) in Patients With Advanced Renal Carcinoma

OBJECTIVES: I. Define the safety of iodine I 131 chimeric monoclonal antibody G250 (131I
MOAB cG250) in patients with advanced renal cell carcinoma. II. Determine the maximum
tolerated dose (MTD) of 131I MOAB cG250. III. Describe the pharmacokinetics and
biodistribution of 131I MOAB cG250. IV. Determine the response rate of 131I MOAB cG250 at
the MTD.

OUTLINE: This is a dose escalation study. Initially patients receive a scout dose of IV
iodine I 131 chimeric monoclonal antibody G250 (131I MOAB cG250) over 10 minutes to
determine whole body clearance. One week later, patients receive incremental doses of IV
131I MOAB cG250 over 10 minutes at 2-3 day intervals for 2-6 weeks. Dose escalation begins
at least 8 weeks after the last infusion of 131I MOAB cG250. In the absence of dose limiting
toxicity in the first 3 patients treated, subsequent cohorts of 3 patients each receive
escalating doses of 131I MOAB cG250 on the same schedule. If dose limiting toxicity occurs
in 4 of 6 patients treated at a given dose level, then dose escalation ceases and the next
lower dose is declared the maximum tolerated dose (MTD). Treatment continues once recovery
from all toxic effects occurs, beginning 8 to 12 weeks following the last course of 131I
MOAB cG250. Patients achieving complete remission, partial remission, or stable disease
receive up to 3 courses of treatment. Treatment ceases once disease progression is reached
following 8 weeks of 131I MOAB cG250.

PROJECTED ACCRUAL: This study will accrue a maximum of 48 patients, with 24 patients per
Phase, at an anticipated enrollment of 2 patients per month over 24 months.