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Randomized Pilot Study of Supplemental Iscar in Combination With Gemcitabine vs. Gemcitabine Alone as Second Line Treatment for Advanced Non-Small Cell Lung Cancer.


N/A
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

Randomized Pilot Study of Supplemental Iscar in Combination With Gemcitabine vs. Gemcitabine Alone as Second Line Treatment for Advanced Non-Small Cell Lung Cancer.


RAndomized pilot study of supplemental Iscar in combination with Gemcitabine vs. Gemcitabine
alone as second line treatment for advanced non-small cell lung cancer.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine if Iscar improves immune function and quality of life.

Principal Investigator

Renato V. LaRocca, MD

Investigator Role:

Study Director

Investigator Affiliation:

Kentuckiana Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

1056757

NCT ID:

NCT00283478

Start Date:

May 2004

Completion Date:

April 2007

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Advanced stage
  • Lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Kentuckiana Cancer InstituteLouisville, Kentucky  40202