Biological Therapy in Previously Treated Patients With Non-small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00003090
- Lead Sponsor
- Cancer Biotherapy Research Group
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Bloomington Hospital
🇺🇸Bloomington, Indiana, United States
Bergan Mercy Medical Center
🇺🇸Omaha, Nebraska, United States
St. Joseph Regional Cancer Center
🇺🇸Bryan, Texas, United States
Bloomington Hospital🇺🇸Bloomington, Indiana, United States