Iscar for Second Line Treatment of Advanced Non-Small Cel... | NCT00283478

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

NCT00283478

Sponsor

Kentuckiana Cancer Institute

Status

Completed

Last Update Posted

Oct 31, 2007Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Non-Small Cell Lung Cancer

Interventions

Iscar Quercus
Gemcitabine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Mistletoe

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

May 2004

Primary Completion Date

Not provided

Completion Date

Apr 2007Actual

First Submitted Date

Jan 26, 2006

First Submission Date that Met QC Criteria

Jan 26, 2006

First Posted Date

Jan 30, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2007

Last Update Posted Date

Oct 31, 2007Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Measure	Description	Time Frame
To determine if Iscar improves immune function and quality of life.

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Renato V. LaRocca, MD	Kentuckiana Cancer Institute	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kentuckiana Cancer Institute		Louisville	Kentucky	40202	United States

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000093542	Gemcitabine

Ancestor Terms

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Iscar Quercus	Drug
Gemcitabine	Drug