Mistletoe in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Are Receiving Palliative Chemotherapy
NCT ID: NCT00052325
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
INTERVENTIONAL
2002-10-31
Brief Summary
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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
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* 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
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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mistletoe extract
Eligibility Criteria
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Inclusion Criteria
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)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sidney Kimmel Cancer Center at Thomas Jefferson University
OTHER
Principal Investigators
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Steven Rosenzweig, MD
Role: STUDY_CHAIR
Sidney Kimmel Cancer Center at Thomas Jefferson University
Locations
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Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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TJUH-01F.45
Identifier Type: -
Identifier Source: secondary_id
TJUH-2001-35
Identifier Type: -
Identifier Source: secondary_id
CDR0000258166
Identifier Type: -
Identifier Source: org_study_id