RATIONALE: Monoclonal antibodies such as MDX-060 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of MDX-060 monoclonal antibody in treating patients who have refractory or relapsed lymphoma.
OBJECTIVES: * Determine the safety and tolerability of MDX-060 monoclonal antibody in patients with refractory or relapsed CD30-positive lymphoma. * Determine the maximum tolerated dose and dose-limiting toxicity of this drug in these patients. * Determine the pharmacokinetic profile of this drug in these patients. * Determine, preliminarily, the efficacy (antilymphoma activity) of this drug in these patients. OUTLINE: This is an open-label, multicenter, dose-escalation study. Patients receive MDX-060 monoclonal antibody IV over 90 minutes once weekly for 4 weeks. Cohorts of 3-6 patients receive escalating doses of MDX-060 monoclonal antibody 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. Once the MTD is determined, an additional 16 patients are accrued and receive MDX-060 monoclonal antibody at the MTD. Patients are followed monthly for 3 months and then every 3 months for 18 months or until disease progression. PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.