Alefacept in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma or Peripheral T-Cell Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Combinations of biological substances in alefacept may be able to carry
      cancer-killing substances directly to cancer cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of alefacept in
      treating patients with relapsed or refractory cutaneous T-cell lymphoma or peripheral T-cell
      non-Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose or the optimal immunologic dose of alefacept in
           patients with relapsed or refractory cutaneous T-cell lymphoma or peripheral T-cell
           non-Hodgkin's lymphoma.

      Secondary

        -  Determine if antitumor activity of this drug exists in these patients.

      OUTLINE: This is a multicenter, dose-escalation study.

        -  Induction therapy: Patients receive alefacept IV over 2-5 minutes once weekly for up to
           8 weeks in the absence of disease progression or unacceptable toxicity. Patients with
           stable disease or complete or partial response after induction therapy proceed to
           maintenance therapy.

      Cohorts of 6 patients receive escalating doses of alefacept until the maximum tolerated dose
      (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
      experience dose-limiting toxicity. The optimal immunologic dose is defined as the dose that
      does not exceed the MTD, has the highest alefacept level, and achieves saturation of CD2
      receptors.

        -  Maintenance therapy: Patients receive alefacept IV on day 1. Treatment repeats every 4
           weeks for 10-12 courses in the absence of disease progression or unacceptable toxicity.

      Patients who experience disease progression during maintenance therapy may receive
      reinduction therapy* comprising 4 weekly doses of alefacept. The patient then proceeds to a
      second maintenance phase in the absence of disease progression.

      NOTE: *Only 1 reinduction allowed.

      Patients undergo blood and tissue collection periodically for pharmacological studies. Blood
      serum is analyzed for alefacept concentration, cytokine concentration, CD16 polymorphisms,
      and CD2 saturation via flow cytometry.

      After completion of study treatment, patients are followed every 3 months for up to 3 years
      and then periodically thereafter.

      PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
    

Intervention name(s): Alefacept
Intervention type(s): Drug
Intervention description(s): Dose escalation theme. 0.075mg/kg by IV Weekly x 8 to 0.30mg/kg IV Weekly x 8
Other intervention name(s): Amevive
Intervention MeSH terms: Alefacept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent cutaneous T-cell non-Hodgkin lymphoma; angioimmunoblastic T-cell lymphoma; anaplastic large cell lymphoma; adult nasal type extranodal NK/T-cell lymphoma; recurrent mycosis fungoides/Sezary syndrome