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HeFi-1 Antibody Therapy in Ki-1 and Hodgkin's Lymphomas, a Phase I Study (NCT00003741)

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients with refractory anaplastic large cell lymphoma or Hodgkin's lymphoma.
  • Biological: monoclonal antibody HeFi-1
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    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.

    1 locations

    United States (1)
    • Beth Israel Deaconess Medical Center
      Boston, Massachusetts, United States, 02215
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    31 January, 1999
    Updated:
    24 June, 2013
    Participants:
    0
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