Finding studies
Finding studies
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Lead
Memorial Sloan Kettering Cancer Center
With
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.
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
