Lymphoma Clinical Trial
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
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.
;
Masking: Open Label, Primary Purpose: Treatment
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