Non-Small Cell Lung CancerNCT00283478
Iscar for Second Line Treatment of Advanced Non-Small Cell Lung Cancer
A study testing Iscar Quercus and Gemcitabine in people with Non-Small Cell Lung Cancer, run by Kentuckiana Cancer Institute at 1 site in United States.
Trial summary
To determine if Iscar Quercus improves immune function and quality of life among patients with stage IV non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Iscar Quercus and Gemcitabine
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kentuckiana Cancer Institute
Louisville, Kentucky, 40202
About this study
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.
To determine if Iscar Quercus improves immune function and quality of life among patients with stage IV non-small cell lung cancer.
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Iscar Quercus, Gemcitabine
- Keywords
- Advanced stage, Lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iscar QuercusDrug
GemcitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if Iscar improves immune function and quality of life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2006 (estimated)
- Study startMay 2004
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kentuckiana Cancer Institute
- Sponsor type
- University, hospital or other
- Investigators
- Renato V. LaRocca, MD, Study director, Kentuckiana Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283478
- Sponsor's protocol ID
- 1056757
- Other IDs
- Mistletoe
- Status last verified
- Oct 2007
- First submitted
- 26 Jan 2006
- Last updated
- 31 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00283478
- Acronym / sponsor ID
- 1056757
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Advanced stage, Lung cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kentuckiana Cancer InstituteUniversity, hospital or other
- Study start
- May 2004
- Study completion
- Apr 2007 (actual)
- First posted
- 30 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iscar Quercus | Drug | – |
| Gemcitabine | Drug | – |
Primary outcome
To determine if Iscar improves immune function and quality of life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renato V. LaRocca, MD study director
Kentuckiana Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iscar Quercus and Gemcitabine in people with Non-Small Cell Lung Cancer, run by Kentuckiana Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if Iscar improves immune function and quality of life.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2007.