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Home > "I" Clinical Trials Conditions > INS316 Compared With Saline for Sputum Collection in Diagnosing Lung Cancer  INS316 Compared With Saline for Sputum Collection in Diagnosing Lung Cancer
INS316 Compared With Saline for Sputum Collection in Diagnosing Lung Cancer
For Condition: Small Cell Lung Cancer,Non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Jonsson Comprehensive Cancer Center
Synopsis: RATIONALE: INS316 may produce a better sputum sample for laboratory analysis and may provide a less invasive method of diagnosing lung cancer. PURPOSE: Randomized diagnostic trial to compare the effectiveness of INS316 with that of saline for sputum collection in diagnosing lung cancer in patients suspected of having lung cancer.
Details: OBJECTIVES: I. 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. II. Compare the relative sensitivity of sputum cytology in the diagnosis of primary lung cancer using these methods of sputum collection in these patients. III. Compare the amount of sputum collected from patients using these methods. IV. Correlate the number of macrophages in sputum with the predictive likelihood of obtaining a positive diagnosis by sputum cytology in these patients. V. Determine whether specificity of sputum cytology is adversely affected by induction with INS316 in these patients. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 - FEV1 at least 40% predicted --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JennyMao, Study Chair, Jonsson Comprehensive Cancer Center
Additional Information:
Study ID Numbers: CDR0000069297; NCI-G02-2055,UCLA-010302101,IP-01-312
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033527
Other Non-Small Cell Lung Cancer Studies:
1. Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients with Sensitive Small Cell Lung Cancer (SCLC)
2. Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults
3. Chest X-ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer
4. Inositol in Preventing Lung Cancer in Patients With Bronchial Epithelial Dysplasia Who Are Current or Former Smokers
5. Oltipraz in the Prevention of Lung Cancer in People Who Smoke
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INS316 Compared With Saline for Sputum Collection in Diagnosing Lung Cancer
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