Interferon Alfa-2b in Treating Patients With Advanced Low-Grade Non-Hodgkin's Lymphoma
RATIONALE: Interferon alfa may interfere with the growth of the cancer cells and slow the growth of non-Hodgkin's lymphoma.
PURPOSE: Phase II trial to study the effectiveness of interferon alfa-2b in treating patients who have advanced low-grade non-Hodgkin's lymphoma.
|Lymphoma Small Intestine Cancer||Biological: pegylated interferon alfa||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of Weekly Administered High-Dose Pegylated Interferon Alfa-2B (PEGIntron) in Advanced Stage Low Grade Non-Hodgkin's Lymphoma|
|Study Start Date:||December 1999|
|Study Completion Date:||March 2001|
|Primary Completion Date:||March 2001 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the response in patients with minimally treated or previously untreated advanced low-grade non-Hodgkin's lymphoma treated with pegylated interferon alfa-2b. II. Determine the effects of this treatment regimen on the immune system by measuring T-cell subsets and NK cells in this patient population. III. Determine event-free and progression-free survival in this patient population treated with this regimen. IV. Evaluate the toxicity profile of this treatment regimen in these patients.
OUTLINE: Patients receive pegylated interferon alfa-2b subcutaneously once weekly for 6 months in the absence of disease progression or unacceptable toxicity. Upon completion of treatment, patients are followed every 6 months for at least 2 years.
PROJECTED ACCRUAL: A total of 30 patients will be initially accrued for this study. Additional patients will be accrued if acceptable responses are seen in the first cohort.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006039
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Carol S. Portlock, MD||Memorial Sloan Kettering Cancer Center|