Biological Therapy in Previously Treated Patients With Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00003090|
Recruitment Status : Unknown
Verified July 2000 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : August 2, 2004
Last Update Posted : November 6, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Biological: aldesleukin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Official Title:||Phase II Trial of Bolus Interleukin-2 in Previously Treated Lung Cancer|
|Study Start Date :||January 1996|
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): 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|