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INS316 in Diagnosing Lung Cancer in Patients With Untreated Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00008255
Recruitment Status : Completed
First Posted : May 5, 2004
Last Update Posted : June 26, 2013
Information provided by:

January 6, 2001
May 5, 2004
June 26, 2013
August 2000
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Complete list of historical versions of study NCT00008255 on ClinicalTrials.gov Archive Site
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INS316 in Diagnosing Lung Cancer in Patients With Untreated Lung Cancer
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.

Phase 2
Primary Purpose: Diagnostic
Lung Cancer
  • Drug: INS316
  • Other: sputum cytology
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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May 2004
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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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000068391 ( Registry Identifier: PDQ (Physician Data Query) )
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Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Robert J. Korst, MD Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
May 2001

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