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

This study has been completed.

First Received: January 26, 2006 Last Updated: October 30, 2007 History of Changes

Sponsor:	Kentuckiana Cancer Institute
Information provided by:	Kentuckiana Cancer Institute
ClinicalTrials.gov Identifier:	NCT00283478

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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

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

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

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

Keywords provided by Kentuckiana Cancer Institute:

Advanced stage
Lung cancer

Additional relevant MeSH terms:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Gemcitabine

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010