Phase I/II Open Label, Dose-Escalating Study of MDX-060 Administered Weekly for 4 Weeks in Patients With Refractory/Relapsed CD30 Lymphoma
- 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
- Determine the pharmacokinetic profile of this drug in these patients.
- Determine, preliminarily, the efficacy (antilymphoma activity) of this drug in these
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
Patients are followed monthly for 3 months and then every 3 months for 18 months or until
PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Steven M. Horwitz, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University||Columbus, Ohio 43210-1240|