|
INS316 in Diagnosing Lung Cancer in Patients With Untreated Lung Cancer Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on INS316 in Diagnosing Lung Cancer in Patients With Untreated Lung Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. INS316 in Diagnosing Lung Cancer in Patients With Untreated Lung Cancer Clinical research trials and INS316 in Diagnosing Lung Cancer in Patients With Untreated Lung Cancer health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like INS316 in Diagnosing Lung Cancer in Patients With Untreated Lung Cancer. INS316 in Diagnosing Lung Cancer in Patients With Untreated Lung Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a INS316 in Diagnosing Lung Cancer in Patients With Untreated Lung Cancer clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their INS316 in Diagnosing Lung Cancer in Patients With Untreated Lung Cancer condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "I" Clinical Trials Conditions > INS316 in Diagnosing Lung Cancer in Patients With Untreated Lung Cancer  INS316 in Diagnosing Lung Cancer in Patients With Untreated Lung Cancer
INS316 in Diagnosing Lung Cancer in Patients With Untreated Lung Cancer
For Condition: Small Cell Lung Cancer,Non-small cell lung cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertKorst, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000068391; NCI-G00-1894,MSKCC-00092
Study Start Date: August 2000
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008255
Other Non-Small Cell Lung Cancer Studies:
1. Celecoxib in Preventing Lung Cancer in Former Heavy Smokers
2. Evaluation of efficacy, safety and tolerability of Targretin capsules in patients with advanced or metastatic non-small cell lung cancer
3. Induction Therapy Using Cisplatin, Etoposide, and Radiation Therapy Followed By Consolidation Therapy Using Gemcitabine With or Without Docetaxel in Treating Patients With Unresectable Stage IIIB Non-Small Cell Lung Cancer
4. BB-10901 in Treating Patients With Recurrent or Refractory Lung Cancer, Metastatic Carcinoid Tumor, or Other Solid Tumors
5. Isotretinoin With or Without Vitamin E for Prevention of Lung Cancer
Related Studies:
Other Non-small cell lung cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
INS316 in Diagnosing Lung Cancer in Patients With Untreated Lung Cancer
|
|
|
|
|
|
|
|
