Rituximab Plus Interleukin-2 in Treating Patients With Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00003356|
Recruitment Status : Completed
First Posted : March 22, 2004
Last Update Posted : October 16, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: aldesleukin Biological: rituximab||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|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|
|Actual Primary Completion Date :||May 2002|
|Actual Study Completion Date :||May 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|