A Phase I Study Of LMB-9, A Recombinant Disulfide Stabilized Anti-Lewis Y Immonutoxin Administered By 5-Days Continuous Infusion For Patients With Colorectal Adenocarcinoma
- Determine the toxicity of LMB-9 immunotoxin in patients with advanced adenocarcinoma of
the colon, rectum, pancreas, esophagus, or stomach with overexpression of the Lewis-Y
- Determine the maximum tolerated dose of this drug in these patients.
- Determine the clinical response of patients treated with this drug.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive LMB-9 immunotoxin IV continuously on days 1-5. Patients with stable or
responding disease after completion of the first course receive additional courses every 4-5
weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of LMB-9 immunotoxin until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which
at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 3 weeks and then every 2 months thereafter.
PROJECTED ACCRUAL: A total of 40-50 patients will be accrued for this study within 1-2
Primary Purpose: Treatment
Peter Hafkemeyer, MD
United States: Federal Government