Phase II Trial of Bolus Interleukin-2 in Previously Treated Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Cancer Biotherapy Research Group
- Enrollment
- 30
- Locations
- 3
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified