Lung CancerPhase 2NCT00052325
Mistletoe in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Are Receiving Palliative Chemotherapy
A Phase 2 study testing mistletoe extract in people with Lung Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
RATIONALE: Mistletoe may help the body build an immune response and may improve quality of life to help patients live more comfortably. PURPOSE: This phase II trial is studying mistletoe to see how well it works in treating patients who are receiving palliative chemotherapy for stage IIIB or stage IV non-small cell… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- mistletoe extract
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to not given
- Phase
- Phase 2
- 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
DISEASE CHARACTERISTICS:
- Stage IIIB or IV non-small cell lung cancer
- Newly diagnosed disease
- Planning to receive standard chemotherapy with either carboplatin plus paclitaxel or cisplatin plus gemcitabine
- Refused or ineligible to participate in experimental chemotherapy clinical trials
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant
- No AIDS
- Able to self-report quality of life
- No known allergy to Viscum album Linnaeus
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No other concurrent mistletoe products
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- No concurrent steroid or adrenocorticotropic hormone therapy
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No concurrent participation in other clinical trials
- No concurrent mushroom glucan or proteoglycan extracts
- No concurrent thymus extract
- No concurrent non-oncologic immunosuppressive therapy (e.g., therapy for rheumatoid arthritis or after organ transplantation)
Trial locations and contacts
1 site in 1 country.
United States1 site
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107
About this study
Official title: Iscar For Supplemental Care In Advanced Non-Small Cell Lung Carcinoma
RATIONALE: Mistletoe may help the body build an immune response and may improve quality of life to help patients live more comfortably.
PURPOSE: This phase II trial is studying mistletoe to see how well it works in treating patients who are receiving palliative chemotherapy for stage IIIB or stage IV non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
- Determine whether supplemental treatment with mistletoe increases immune function (as determined by total lymphocyte count, eosinophil count, and lymphocyte subset analysis) in patients with stage IIIB or IV non-small cell lung cancer receiving palliative chemotherapy.
- Determine the tolerability of this drug in these patients.
- Correlate immune function and quality of life in patients treated with this drug.
OUTLINE: This is an open-label, non-randomized, multicenter study.
Patients receive mistletoe subcutaneously three times a week for 15 weeks.
Dose of mistletoe is increased at weeks 2 and 3 and then every 3 weeks until a maximum response is seen, dose-limiting toxicity occurs, or the study ends.
Quality of life is assessed at baseline and at weeks 3, 6, 9, 12, and 15.
PROJECTED ACCRUAL: Not specified
- Conditions
- Lung Cancer
- Being tested
- mistletoe extract
- Keywords
- stage IV non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mistletoe extractDietary supplement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Steven Rosenzweig, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00052325
- Sponsor's protocol ID
- CDR0000258166
- Other IDs
- TJUH-01F.45, TJUH-2001-35
- Status last verified
- Jul 2005
- First submitted
- 24 Jan 2003
- Last updated
- 18 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iscar For Supplemental Care In Advanced Non-Small Cell Lung Carcinoma
- ClinicalTrials.gov ID
- NCT00052325
- Acronym / sponsor ID
- CDR0000258166
- Conditions
- Lung Cancer
- Keywords
- stage IV non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2002
- First posted
- 27 Jan 2003 (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.
RATIONALE: Mistletoe may help the body build an immune response and may improve quality of life to help patients live more comfortably.
PURPOSE: This phase II trial is studying mistletoe to see how well it works in treating patients who are receiving palliative chemotherapy for stage IIIB or stage IV non-small cell lung cancer.
Detailed description
OBJECTIVES:
- Determine whether supplemental treatment with mistletoe increases immune function (as determined by total lymphocyte count, eosinophil count, and lymphocyte subset analysis) in patients with stage IIIB or IV non-small cell lung cancer receiving palliative chemotherapy.
- Determine the tolerability of this drug in these patients.
- Correlate immune function and quality of life in patients treated with this drug.
OUTLINE: This is an open-label, non-randomized, multicenter study.
Patients receive mistletoe subcutaneously three times a week for 15 weeks.
Dose of mistletoe is increased at weeks 2 and 3 and then every 3 weeks until a maximum response is seen, dose-limiting toxicity occurs, or the study ends.
Quality of life is assessed at baseline and at weeks 3, 6, 9, 12, and 15.
PROJECTED ACCRUAL: Not specified
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| mistletoe extract | Dietary supplement | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
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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.
Steven Rosenzweig, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mistletoe extract in people with Lung Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University 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?
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: status not confirmed, as of the sponsor's last update on 18 Dec 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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.
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 18 Dec 2013.