Spots Global Cancer Trial Database for Biological Therapy in Previously Treated Patients With Non-small Cell Lung Cancer

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Trial Identification

Brief Title: Biological Therapy in Previously Treated Patients With Non-small Cell Lung Cancer

Official Title: Phase II Trial of Bolus Interleukin-2 in Previously Treated Lung Cancer

Study ID: NCT00003090

Conditions

Lung Cancer

Interventions

aldesleukin

Study Description

Brief Summary: 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.

Detailed Description: 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.