Colorectal Cancer Clinical Trial
Official title:
A Phase I Single Dose-Escalation Study of BIBH-1 in Patients With Colorectal Cancer Scheduled for Surgical Resection
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.
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.
;
Primary Purpose: Treatment
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