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

This study has been completed.

First Received on January 26, 2006. Last Updated on 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:	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:

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

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 February 09, 2012