Rituximab Plus Interleukin-2 in Treating Patients With 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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of Rituxan and IL-2 in Patients With Low Grade or Follicular B-Cell Lymphoma|
|Study Start Date:||November 1997|
|Study Completion Date:||May 2002|
|Primary Completion Date:||May 2002 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003356
|United States, New York|
|University of Rochester Cancer Center|
|Rochester, New York, United States, 14642|
|Study Chair:||Joseph D. Rosenblatt, MD||University of Miami Sylvester Comprehensive Cancer Center|