Monoclonal Antibody Therapy in Treating Patients With Prostate 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 trial to study the effectiveness of monoclonal antibody therapy in treating patients who have prostate cancer that no longer responds to antiandrogen therapy.
Biological: monoclonal antibody muJ591
Radiation: iodine I 131 monoclonal antibody muJ591
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Evaluation of 131I-J591 Murine Monoclonal Antibody in Patients With Progressive Androgen-Independent Prostate Cancer|
|Study Start Date:||September 2000|
|Study Completion Date:||March 2002|
|Primary Completion Date:||March 2002 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the biodistribution and normal organ dosimetry of iodine I 131 monoclonal antibody muJ591 in patients with progressive androgen independent prostate cancer. II. Determine the safety of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients. IV. Determine the human antimouse antibody response in these patients to this drug. V. Determine the antitumor effects of this drug in these patients.
OUTLINE: This is a dose escalation study of iodine I 131 monoclonal antibody muJ591 (131I-J591). Patients receive unlabeled monoclonal antibody muJ591 IV over 1 hour followed by 131I-J591 IV over 1 hour. Cohorts of 3-6 patients receive escalating doses of 131I-J591 (radioactivity is escalated, monoclonal antibody dose is fixed) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose limiting toxicity. Patients are followed at weeks 3, 4, 6, 8, 9, and 12, and then every 6 months until month 21.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study over 12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006380
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Howard I. Scher, MD||Memorial Sloan Kettering Cancer Center.|