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Sponsored by: |
Cancer Biotherapy Research Group |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003090 |
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 | Intervention | Phase |
Lung Cancer |
Drug: aldesleukin |
Phase II |
MedlinePlus related topics: | Cancer Lung Cancer |
ChemIDplus related topics: | Aldesleukin Interleukin-2 |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Trial of Bolus Interleukin-2 in Previously Treated Lung Cancer |
Estimated Enrollment: | 30 |
Study Start Date: | January 1996 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory non-small cell lung cancer At least one prior systemic therapy OR prior radiation therapy Must have measurable disease Previously irradiated sites of disease are not considered evaluable unless there is radiologic documentation of progression
PATIENT CHARACTERISTICS: Age: Not specified Performance Status: ECOG 0-2 Life Expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm3 Hemoglobin greater than 10 g/dL Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No prior history of myocardial infarction within previous 6 months No uncompensated congestive heart failure No primary (not due to electrolytes or drugs) cardiac arrhythmias besides premature ventricular contractions Pulmonary: No dyspnea at rest or need for supplemental oxygen Patients with symptomatic lung disease or extensive lung metastases must have oxygen saturation greater than 90% Other: Not pregnant or nursing Negative pregnancy test Patients with elevated temperatures greater than 100.5 F must have no occult infection
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent cyclosporin Chemotherapy: At least 3 weeks since chemotherapy and recovered No concurrent methotrexate See Disease Characteristics Endocrine therapy: No concurrent systemic corticosteroids Radiotherapy: At least 3 weeks since radiotherapy See Disease Characteristics Surgery: Not specified
United States, Indiana | |||||
Bloomington Hospital | |||||
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 |
Cancer Biotherapy Research Group |
Study Chair: | Datchen F. Tai, MD | Cancer Biotherapy Research Group |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000065794, CBRG-9602, NBSG-9602, NCI-V97-1345 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003090 |
Health Authority: | United States: Federal Government |
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