RATIONALE: Immunotoxins can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of LMB-2 immunotoxin in treating patients who have leukemia or lymphoma.
OBJECTIVES: * Assess the therapeutic efficacy and toxicity of the recombinant immunotoxin LMB-2, an anti-Tac murine monoclonal antibody fragment conjugated to a truncated portion of Pseudomonas exotoxin, in patients with Tac-expressing leukemias and lymphomas. * Define the pharmacokinetics of LMB-2, including the terminal elimination serum half-life, area under the curve, and volume of distribution. * Evaluate, in a preliminary manner, the immunogenicity of LMB-2 in these patients. * Determine the effect of LMB-2 on various components of the circulating cellular immune system. OUTLINE: This is a dose escalation study. Patients receive LMB-2 immunotoxin IV over 30 minutes on days 1, 3, and 5. Treatment repeats every 15-21 days for up to 10 courses in the absence of disease progression, neutralizing antibodies, or unacceptable toxicity. Cohorts of 3-6 patients each receive escalating doses of LMB-2 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 patient experiences dose limiting toxicity. PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Laboratory of Molecular Biology
Bethesda, Maryland, United States
Medicine Branch
Bethesda, Maryland, United States
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.