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Iscar for Second Line Treatment of Advanced Non-Small Cell 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: NCT00283478
Recruitment Status : Completed
First Posted : January 30, 2006
Last Update Posted : October 31, 2007
Sponsor:
Information provided by:
Kentuckiana Cancer Institute

Tracking Information
First Submitted Date  ICMJE January 26, 2006
First Posted Date  ICMJE January 30, 2006
Last Update Posted Date October 31, 2007
Study Start Date  ICMJE May 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2006)		 To determine if Iscar improves immune function and quality of life.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Iscar for Second Line Treatment of Advanced Non-Small Cell Lung Cancer
Official Title  ICMJE Randomized Pilot Study of Supplemental Iscar in Combination With Gemcitabine vs. Gemcitabine Alone as Second Line Treatment for Advanced Non-Small Cell Lung Cancer.
Brief Summary To determine if Iscar Quercus improves immune function and quality of life among patients with stage IV non-small cell lung cancer.
Detailed Description RAndomized pilot study of supplemental Iscar in combination with Gemcitabine vs. Gemcitabine alone as second line treatment for advanced non-small cell lung cancer.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Iscar Quercus
  • Drug: Gemcitabine
Study Arms  ICMJE 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 Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 26, 2006)		 20
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • newly diagnosed IIIB and IV NSCLC who have failed one prior line of chemo
  • Karnofsky score 60% or greater
  • patients who will be treated with Gemcitabine
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00283478
Other Study ID Numbers  ICMJE 1056757
Mistletoe
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Kentuckiana Cancer Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Renato V. LaRocca, MD Kentuckiana Cancer Institute
PRS Account Kentuckiana Cancer Institute
Verification Date October 2007

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