Rituximab Plus Interleukin-2 in Treating Patients With Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver
      cancer-killing substances to them without harming normal cells. Interleukin-2 may stimulate a
      person's white blood cells to kill cancer cells.

      PURPOSE: Phase I/II trial to study the effectiveness of combining rituximab and interleukin-2
      intreating patients who have low-grade mantle cell lymphoma or follicular lymphoma.
    

Detailed description: 
      OBJECTIVES: I. Determine the response rate in patients with low-grade, mantle cell, or
      follicular B-cell lymphoma treated with a combination of rituximab and low-dose interleukin-2
      (IL-2). II. Determine the maximum tolerated dose of IL-2 when given in conjunction with
      rituximab in this patient population. III. Assess whether antibody dependent cellular
      cytotoxicity (ADCC) is enhanced by in vivo exposure to IL-2 and whether ADCC activity
      correlates with clinical response in these patients. IV. Assess the incidence of
      antirituximab antibody formation in these patients.

      OUTLINE: Patients receive interleukin-2 (IL-2) subcutaneously on days 1-5 and rituximab IV on
      day 3. Courses repeat weekly for up to 4 weeks in the absence of disease progression or
      unacceptable toxicity. Patients are followed weekly for 4 weeks and then every 3 months for 1
      year.

      PROJECTED ACCRUAL: A total of 14-29 patients with low-grade/follicular lymphoma and 14-29
      patients with mantle cell lymphoma will be accrued for this study within 2-5 years.
    

Intervention name(s): aldesleukin; rituximab
Intervention type(s): Biological; Biological
Intervention MeSH terms: Aldesleukin; Rituximab
Primary purpose: Treatment
Keywords: stage I grade 1 follicular lymphoma; stage I grade 2 follicular lymphoma; stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; stage I mantle cell lymphoma; contiguous stage II grade 1 follicular lymphoma; contiguous stage II grade 2 follicular lymphoma; contiguous stage II mantle cell lymphoma; noncontiguous stage II grade 1 follicular lymphoma; noncontiguous stage II grade 2 follicular lymphoma; noncontiguous stage II mantle cell lymphoma; stage III mantle cell lymphoma; stage IV mantle cell lymphoma; recurrent mantle cell lymphoma; noncontiguous stage II small lymphocytic lymphoma; noncontiguous stage II marginal zone lymphoma; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; stage I marginal zone lymphoma; stage I small lymphocytic lymphoma; stage III small lymphocytic lymphoma; stage III marginal zone lymphoma; stage IV small lymphocytic lymphoma; stage IV marginal zone lymphoma; contiguous stage II marginal zone lymphoma; contiguous stage II small lymphocytic lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma