Monoclonal Antibody Therapy in Treating Patients With Colorectal 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 colorectal cancer.
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Procedure: radionuclide imaging
Radiation: iodine I 131 monoclonal antibody F19
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Single Dose-Escalation Study of BIBH-1 in Patients With Colorectal Cancer Scheduled for Surgical Resection|
|Study Start Date:||September 1999|
|Study Completion Date:||August 2000|
|Primary Completion Date:||August 2000 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine any toxicity associated with increasing single doses of monoclonal antibody F19 (BIBH-1) administered by intravenous infusion in patients with colorectal cancer scheduled for surgical resection. II. Compare the pharmacokinetics, biodistribution, and imaging characteristics of increasing intravenous doses of iodine I 131 BIBH-1 in this patient population. III. Compare the BIBH-1 related human antihuman antibody (HAHA) serum concentration with immunologic related clinical effects in these patients. IV. Compare the uptake of iodine I 131 BIBH-1 in tumor to the uptake of normal tissue when administered to these patients.
OUTLINE: This is a dose escalation study. Patients receive monoclonal antibody F19 (BIBH-1) combined with iodine I 131 IV over 60 minutes. Patients undergo surgical resection approximately 7 days after BIBH-1 infusion. Cohorts of 3-6 patients receive escalating doses of BIBH-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Patients are followed once during days 5-14 and then at day 30 after surgery.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 4 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005616
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Sydney Welt, MD||Memorial Sloan Kettering Cancer Center|