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

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ClinicalTrials.gov Identifier: NCT00283478

Recruitment Status : Completed

First Posted : January 30, 2006

Last Update Posted : October 31, 2007

Sponsor:

Information provided by:

Kentuckiana Cancer Institute

Tracking Information

First Submitted Date ^ICMJE

January 26, 2006

First Posted Date ^ICMJE

January 30, 2006

Last Update Posted Date

October 31, 2007

Study Start Date ^ICMJE

May 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Non-Small Cell Lung Cancer

Intervention ^ICMJE

Drug: Iscar Quercus
Drug: Gemcitabine

Study Arms ^ICMJE

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Original Enrollment ^ICMJE

Same as current

Actual Study Completion Date ^ICMJE

April 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00283478

Other Study ID Numbers ^ICMJE

1056757
Mistletoe

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Kentuckiana Cancer Institute

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Renato V. LaRocca, MD

Kentuckiana Cancer Institute

PRS Account

Kentuckiana Cancer Institute

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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