Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Immunotoxin for Advanced Carcinomas That Express Lewis Y Antigen
OBJECTIVES: I. Determine the toxic effects and the pharmacokinetics of LMB-9 immunotoxin in
patients with advanced solid tumors that express Lewis Y antigen. II. Evaluate the
anti-tumor activity and the immunogenicity of this treatment regimen in these patients.
OUTLINE: This is a dose-escalation study. Patients receive LMB-9 immunotoxin IV over 30
minutes on days 1, 3, and 5. Patients with negative neutralizing antibody to LMB-9
immunotoxin with stable or responding disease receive additional courses every 4 weeks in
the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive
escalating doses of LMB-9 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
toxicity. Once the MTD is determined, an additional cohort of 6 patients may be treated at
the MTD. Patients are followed at 1 month and then every 2 months thereafter.
PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued within 12-24 months.
Primary Purpose: Treatment
Ira Pastan, MD
National Cancer Institute (NCI)
United States: Federal Government
|Medicine Branch||Bethesda, Maryland 20892|