Iscar for Second Line Treatment of Advanced Non-Small Cell Lung Cancer
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Iscar Quercus
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Advanced stage, Lung cancer
Eligibility Criteria
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
Sites / Locations
- Kentuckiana Cancer Institute
Outcomes
Primary Outcome Measures
To determine if Iscar improves immune function and quality of life.
Secondary Outcome Measures
Full Information
NCT ID
NCT00283478
First Posted
January 26, 2006
Last Updated
October 30, 2007
Sponsor
Kentuckiana Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT00283478
Brief Title
Iscar for Second Line Treatment of Advanced Non-Small Cell Lung Cancer
Official Title
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
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kentuckiana Cancer Institute
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Advanced stage, Lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Iscar Quercus
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Primary Outcome Measure Information:
Title
To determine if Iscar improves immune function and quality of life.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renato V. LaRocca, MD
Organizational Affiliation
Kentuckiana Cancer Institute
Official's Role
Study Director
Facility Information:
Facility Name
Kentuckiana Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Iscar for Second Line Treatment of Advanced Non-Small Cell Lung Cancer
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