INS316 in Diagnosing Lung Cancer in Patients With Untreated Lung Cancer
|First Received Date ICMJE||January 6, 2001|
|Last Updated Date||June 25, 2013|
|Start Date ICMJE||August 2000|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00008255 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||INS316 in Diagnosing Lung Cancer in Patients With Untreated Lung Cancer|
|Official Title ICMJE||Evaluation Of Uridine 5-Triphosphate Solution For Inhalation (UTP) As An Adjunct In The Diagnosis Of Lung Cancer By Sputum Cytology|
RATIONALE: Doctors can diagnose lung cancer by collecting mucus coughed up from the lungs and examining it under a microscope to look for cancer cells. Breathing in INS316 may make it easier for patients to cough up mucus.
PURPOSE: Randomized phase II trial to study the effectiveness of INS316 in helping to diagnose lung cancer.
OBJECTIVES: I. Determine whether a cytological diagnosis of lung cancer can be obtained more frequently from sputum specimens following inhalation of INS316 compared to specimens obtained following placebo or compared to specimens spontaneously expectorated in patients with untreated lung cancer. II. Assess the relative sensitivity of sputum cytology in the diagnosis of lung malignancies in this patient population using these sputum collection regimens. III. Determine the quantity of macrophages in sputum of these patients using these techniques. IV. Determine if the number of macrophages in sputum obtained by these methods is predictive of the likelihood of obtaining a positive diagnosis of lung cancer in these patients. V. Determine the total amount of sputum expectorated from these patients using these techniques.
OUTLINE: This is a randomized, double-blind, placebo-controlled, cross-over, multicenter study. Patients are randomized to one of two arms, then cross-over to the other arm. Arm I: Patients receive INS316 by inhalation via a nebulizer. Sputum is collected throughout the dosing and for 1 hour post dosing. Arm II: Patients receive placebo in the same manner as INS136 in arm I. All patients receive both treatments. Patients receive the first dose no more than 7 days after screening, and the second dose 3 to 10 days after the first dose. Patients are followed 1 day after completion of the second treatment. The sputum samples are fixed and examined cytologically.
PROJECTED ACCRUAL: Approximately 100-130 patients will be accrued for this study.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Primary Purpose: Diagnostic|
|Condition ICMJE||Lung Cancer|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Completion Date||May 2004|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
DISEASE CHARACTERISTICS: Histologically or cytologically proven primary lung cancer OR Presumptive diagnosis based on chest x-ray, CT scan, history, or symptoms No prior treatment
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Pulmonary: FEV1 at least 35% predicted Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other comorbid condition that would preclude study
PRIOR CONCURRENT THERAPY: See Disease Characteristics At least 4 days since prior bronchoscopic examination or pulmonary fine needle aspiration biopsy At least 3 days since prior sputum induction No concurrent medication that would preclude study At least 30 days since prior investigational drugs (including INS316) or experimental therapy
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00008255|
|Other Study ID Numbers ICMJE||MSKCC-00092, CDR0000068391, NCI-G00-1894|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Memorial Sloan-Kettering Cancer Center|
|Collaborators ICMJE||National Cancer Institute (NCI)|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||May 2001|
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