Iscar for Second Line Treatment of Advanced Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
Kentuckiana Cancer Institute
ClinicalTrials.gov Identifier:
NCT00283478
First received: January 26, 2006
Last updated: October 30, 2007
Last verified: October 2007
  Purpose

To determine if Iscar Quercus improves immune function and quality of life among patients with stage IV non-small cell lung cancer.


Condition Intervention
Non-Small Cell Lung Cancer
Drug: Iscar Quercus
Drug: Gemcitabine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Kentuckiana Cancer Institute:

Primary Outcome Measures:
  • To determine if Iscar improves immune function and quality of life.

Estimated Enrollment: 20
Study Start Date: May 2004
Study Completion Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00283478

Locations
United States, Kentucky
Kentuckiana Cancer Institute
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Kentuckiana Cancer Institute
Investigators
Study Director: Renato V. LaRocca, MD Kentuckiana Cancer Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00283478     History of Changes
Other Study ID Numbers: 1056757, Mistletoe
Study First Received: January 26, 2006
Last Updated: October 30, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Kentuckiana Cancer Institute:
Advanced stage
Lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 16, 2014