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Phase II Trial of Bolus Interleukin-2 in Previously Treated 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.
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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Bloomington Hospital
Bloomington, Indiana, United States
Bergan Mercy Medical Center
Omaha, Nebraska, United States
St. Joseph Regional Cancer Center
Bryan, Texas, United States
Start Date
January 1, 1996
Last Updated
November 6, 2013
30
ESTIMATED participants
aldesleukin
BIOLOGICAL
Lead Sponsor
Cancer Biotherapy Research Group
NCT05198830
NCT05692635
Data Source & Attribution
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