Lymphoma Clinical Trial
Official title:
A Phase II Study of Rituxan and IL-2 in Patients With Low Grade or Follicular B-Cell Lymphoma
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.
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.
;
Primary Purpose: Treatment
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