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Biological Therapy in Previously Treated Patients With Non-small Cell Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2000 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003090
First received: November 1, 1999
Last updated: November 5, 2013
Last verified: July 2000

November 1, 1999
November 5, 2013
January 1996
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Complete list of historical versions of study NCT00003090 on ClinicalTrials.gov Archive Site
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Biological Therapy in Previously Treated Patients With Non-small Cell Lung Cancer
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.

Interventional
Phase 2
Primary Purpose: Treatment
Lung Cancer
Biological: aldesleukin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
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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

Both
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003090
CDR0000065794, CBRG-9602, NBSG-9602, NCI-V97-1345
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Cancer Biotherapy Research Group
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Study Chair: Datchen F. Tai, MD Cancer Biotherapy Research Group
National Cancer Institute (NCI)
July 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP