Spots Global Cancer Trial Database for Rituximab and Interleukin-2 in Treating Patients With Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma

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Trial Identification

Brief Title: Rituximab and Interleukin-2 in Treating Patients With Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma

Official Title: An Open-Labeled, Phase II Study of Rituximab in Combination With Recombinant IL-2 for Relapsed or Refractory Non-Hodgkin's Lymphoma of Intermediate- or High-Grade Histology

Study ID: NCT00059904

Conditions

Lymphoma

Interventions

aldesleukin

rituximab

Study Description

Brief Summary: RATIONALE: Monoclonal antibodies such as rituximab 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. Combining rituximab with interleukin-2 may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab with interleukin-2 in treating patients who have relapsed or refractory intermediate- or high-grade non-Hodgkin's lymphoma.

Detailed Description: OBJECTIVES: * Determine the clinical efficacy of rituximab and interleukin-2 in patients with relapsed or refractory intermediate- or high-grade non-Hodgkin's lymphoma. * Determine the 2-year progression-free survival of patients treated with this regimen. * Determine the safety of this regimen in these patients. * Correlate response with natural killer cell numbers and rituximab, interleukin-2 (IL-2), and soluble IL-2 receptor levels in patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive rituximab IV once weekly on weeks 1-4 and interleukin-2 subcutaneously 3 times weekly on weeks 2-9. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 12 weeks for 2 years. PROJECTED ACCRUAL: A total of 50-100 patients will be accrued for this study.