Monoclonal Antibody Therapy in Treating Patients With Advanced Kidney Cancer
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy in treating patients with advanced kidney cancer.
Radiation: iodine I 131 chimeric monoclonal antibody G-250
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I/II Study of 131-I-Labeled Chimeric Antibody G250 (131-I-cG250) in Patients With Advanced Renal Carcinoma|
|Study Start Date:||July 1997|
|Primary Completion Date:||August 2000 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003102
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Chaitanya R. Divgi, MD||Memorial Sloan-Kettering Cancer Center|