HeFi-1 Antibody Therapy in Ki-1 and Hodgkin's Lymphomas, a Phase I Study
- 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.
Masking: Open Label, Primary Purpose: Treatment
Henry Koon, MD
Beth Israel Deaconess Medical Center
United States: Federal Government
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|