Biological Therapy in Previously Treated Patients With Non-small Cell Lung Cancer
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill non-small cell lung cancer cells.
PURPOSE: Phase II trial to study the effect of biological therapy with interleukin-2 in patients with previously treated non-small cell lung cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Trial of Bolus Interleukin-2 in Previously Treated Lung Cancer|
|Study Start Date:||January 1996|
OBJECTIVES: I. Determine the response rate and median duration of response of interleukin-2 (IL-2) in patients with previously treated non-small cell lung cancer. II. Determine the median survival of patients treated with IL-2. III. Further delineate the toxicity of IL-2 in these patients.
OUTLINE: This is an open label study. Patients receive bolus interleukin-2 on days 1-5 and 8-12. The cycle repeats every 3 weeks. Patient response is evaluated after 2 cycles. Patients with stable disease, partial, or complete response may be treated with maintenance IL-2 for up to 4 additional cycles. Patient evaluation is performed after every 2 cycles. At this point, patients with stable or responding disease may be treated with IL-2 every 6 weeks until disease progression, intolerable toxic effects, or 2 cycles beyond complete response.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003090
|United States, Indiana|
|Bloomington, Indiana, United States, 47402|
|United States, Nebraska|
|Bergan Mercy Medical Center|
|Omaha, Nebraska, United States, 68124|
|United States, Texas|
|St. Joseph Regional Cancer Center|
|Bryan, Texas, United States, 77802|
|Study Chair:||Datchen F. Tai, MD||Cancer Biotherapy Research Group|