NCT00283478

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable nonsmall-cell-lung-cancer

Timeline
Completed

Started May 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

October 31, 2007

Status Verified

October 1, 2007

First QC Date

January 26, 2006

Last Update Submit

October 30, 2007

Conditions

Non-Small Cell Lung Cancer

Keywords

Advanced stageLung cancer

Outcome Measures

Primary Outcomes (1)

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

Interventions

Iscar QuercusDRUG
GemcitabineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kentuckiana Cancer Institute

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Renato V. LaRocca, MD

    Kentuckiana Cancer Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 26, 2006

First Posted

January 30, 2006

Study Start

May 1, 2004

Study Completion

April 1, 2007

Last Updated

October 31, 2007

Record last verified: 2007-10

Locations

US(1)