Back to results

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

Primary Purpose

Non-Small Cell Lung Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Iscar Quercus

Gemcitabine

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Advanced stage, Lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kentuckiana Cancer Institute

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00283478

First Posted

January 26, 2006

Last Updated

October 30, 2007

Sponsor

Kentuckiana Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT00283478

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Completed

Study Start Date

May 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Kentuckiana Cancer Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Small Cell Lung Cancer

Keywords

Advanced stage, Lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Iscar Quercus

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Renato V. LaRocca, MD

Organizational Affiliation

Kentuckiana Cancer Institute

Official's Role

Study Director

Facility Information:

Facility Name

Kentuckiana Cancer Institute

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs