A Double-Blinded, Placebo-Controlled, Parallel Group Study Of Uridine 5'-Triphosphate (UTP) Solution For Inhalation As An Adjunct In The Diagnosis Of Lung Cancer By Sputum Cytology
18 Years
N/A
Both
Lung Cancer
Trial Information
A Double-Blinded, Placebo-Controlled, Parallel Group Study Of Uridine 5'-Triphosphate (UTP) Solution For Inhalation As An Adjunct In The Diagnosis Of Lung Cancer By Sputum Cytology
OBJECTIVES:
- Compare the number of lung cancer diagnoses obtained from cytological evaluation of
sputum expectorated after inhalation of INS316 versus normal saline as an adjunct for
spontaneous expectoration of sputum in patients with suspected lung cancer.
- Compare the relative sensitivity of sputum cytology in the diagnosis of primary lung
cancer using these methods of sputum collection in these patients.
- Compare the amount of sputum collected from patients using these methods.
- Correlate the number of macrophages in sputum with the predictive likelihood of
obtaining a positive diagnosis by sputum cytology in these patients.
- Determine whether specificity of sputum cytology is adversely affected by induction
with INS316 in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel, multicenter
study. Patients are stratified according to tumor size and location as visualized by chest
radiography, CT scan, or positron-emission tomography scan (peripheral tumor (distal to the
subsegmental bronchi) no greater than 2 cm in diameter vs peripheral tumor greater than 2 cm
in diameter vs central tumor no greater than 2 cm in diameter vs central tumor greater than
2 cm in diameter). Patients are randomized to one of two arms.
Prior to dosing with sputum induction adjunct, all patients expectorate sputum
spontaneously.
- Arm I: Patients receive a single dose of INS316 by inhalation.
- Arm II: Patients receive a single dose of placebo (normal saline) by inhalation.
In both arms, patients expectorate sputum during dosing, immediately after dosing, and then
within 15, 30, and 60 minutes after dosing.
Patients are followed on day 1 after dosing, for up to 8 weeks until a diagnosis is made,
and then up to 3 months if diagnosis is malignant.
PROJECTED ACCRUAL: Approximately 800 patients (or until 600 confirmed diagnoses of
malignancy are made) will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Suspected of having primary lung cancer by chest radiography, CT scan, or
positron-emission tomography scan with symptoms, risk profile, or history suggestive
of malignancy
- No prior confirmed diagnosis for current suspicious lung tumor
- Expected to have a histological or cytological confirmation within 8 weeks after
study completion
- No prior treatment for current suspicious tumor unless current lesion is recurrence
of same tumor (in same location) for which prior treatment was received at least 180
days prior to study
- FEV_1 at least 40% predicted
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other concurrent comorbid condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- See Disease Characteristics
Radiotherapy:
- See Disease Characteristics
Surgery:
- At least 4 days since prior pulmonary fine needle aspiration biopsy
- No concurrent mediastinoscopy or thoracotomy
Other:
- At least 4 days since prior bronchoscopic examination
- At least 3 days since prior sputum induction
- At least 30 days since prior investigational drugs (including INS316) or experimental
therapy
- No concurrent medication that would preclude study participation
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Diagnostic
Principal Investigator
Jenny T. Mao, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000069297
NCT ID:
NCT00033527
Start Date:
Completion Date:
Related Keywords:
- Lung Cancer
- non-small cell lung cancer
- small cell lung cancer
- Lung Neoplasms
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