Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Anti-Lewis Y Immunotoxin Admistered by Continuous Infusion
I. Determine the maximum tolerated dose of LMB-9 immunotoxin in patients with advanced
colon, breast, non-small cell lung, bladder, pancreas, or ovarian cancer.
II. Assess the toxicity and pharmacokinetics of this treatment regimen in these patients.
III. Determine the clinical responses in patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Patients receive LMB-9 immunotoxin IV continuously for 10 days. Treatment continues every 30
days 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 2
of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 3 weeks and then every 2 months thereafter.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Judith E. Karp, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Food and Drug Administration
|Marlene and Stewart Greenebaum Cancer Center, University of Maryland||Baltimore, Maryland 21201-1595|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|