Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkin's Lymphoma
Description
OBJECTIVES:
Determine the safety and tolerability of multiple doses of monoclonal antibody HeFi-1 in patients with CD30+ anaplastic large cell lymphoma or Hodgkin's lymphoma.
Determine the pharmacokinetics of this drug in this patient population.
Evaluate the efficacy, in terms of correlating immunologic parameters and immunogenicity, of this drug in these patients.
OUTLINE: This is an open-label, dose-escalation study.
Patients receive monoclonal antibody HeFi-1 IV over 30 minutes 3 times a week for 2 weeks. Treatment may continue for 2 additional weeks in the absence of anti-HeFi-1 response. Responding patients may continue treatment at monthly intervals for one year.
Cohorts of 3-4 patients receive escalating doses of monoclonal antibody HeFi-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4 patients experience dose-limiting toxicity.
Patients are followed monthly.
PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.
