Expired Study
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Philadelphia, Pennsylvania 19107


Purpose:

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.


Study summary:

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


Criteria:

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)


NCT ID:

NCT00052325


Primary Contact:

Study Chair
Steven Rosenzweig, MD
Kimmel Cancer Center (KCC)


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19107
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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