MDX-060 Monoclonal Antibody in Treating Patients With Refractory or Relapsed Lymphoma
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Open Label, Dose-Escalating Study of MDX-060 Administered Weekly for 4 Weeks in Patients With Refractory/Relapsed CD30 Lymphoma|
|Study Start Date:||January 2003|
|Study Completion Date:||November 2009|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00059995
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University|
|Columbus, Ohio, United States, 43210-1240|
|Study Chair:||Steven M. Horwitz, MD||Memorial Sloan Kettering Cancer Center|