Denileukin Diftitox in Treating Patients With Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Immunotoxins such as denileukin diftitox can locate cancer cells and kill them
      without harming normal cells. This may be an effective treatment for non-Hodgkin's lymphoma.

      PURPOSE: Phase II trial to study the effectiveness of denileukin diftitox in treating
      patients who have non-Hodgkin's lymphoma that has not responded to previous treatment.
    

Detailed description: 
      OBJECTIVES: I. Determine the objective response rate in patients with previously treated
      stage I, II, III, or IV low- or intermediate-grade B-cell non-Hodgkin's lymphoma treated with
      denileukin diftitox. II. Determine the time to progression, duration of remission, and time
      to treatment failure in patients after treatment with this therapy. III. Determine the
      toxicity of this therapy in these patients. IV. Correlate the results of the inteleukin-2
      receptor assay with treatment outcomes in these patients.

      OUTLINE: Patients are stratified according to interleukin-2 receptor classification (positive
      vs negative). Patients receive immunotoxin therapy with denileukin diftitox IV over 15-60
      minutes on days 1-5. Treatment repeats every 21 days for 2-6 courses in the absence of
      disease progression or unacceptable toxicity. Patients are followed every 3 months for 2
      years, every 6 months for 3 years, and then annually thereafter.

      PROJECTED ACCRUAL: A total of 33 patients will be accrued for the interleukin-2 (IL-2)
      receptor-positive stratum and a total of 11-44 patients will be accrued for the IL-2
      receptor-negative stratum.
    

Intervention name(s): denileukin diftitox
Intervention type(s): Biological
Intervention MeSH terms: Denileukin diftitox
Primary purpose: Treatment
Keywords: Waldenstrom macroglobulinemia; stage I grade 1 follicular lymphoma; stage I grade 2 follicular lymphoma; stage I grade 3 follicular lymphoma; stage I adult diffuse large cell lymphoma; stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage III adult diffuse large cell lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma; stage IV adult diffuse large cell lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent adult diffuse large cell lymphoma; contiguous stage II grade 1 follicular lymphoma; contiguous stage II grade 2 follicular lymphoma; contiguous stage II grade 3 follicular lymphoma; contiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II grade 1 follicular lymphoma; noncontiguous stage II grade 2 follicular lymphoma; noncontiguous stage II grade 3 follicular lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; contiguous stage II marginal zone lymphoma; contiguous stage II small lymphocytic lymphoma; noncontiguous stage II small lymphocytic lymphoma; noncontiguous stage II marginal zone lymphoma; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; stage III small lymphocytic lymphoma; stage III marginal zone lymphoma; stage IV small lymphocytic lymphoma; stage IV marginal zone lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma