Mistletoe in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Are Receiving Palliative Chemotherapy

Study Overview
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Brief Summary
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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
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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

Official Title
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Iscar For Supplemental Care In Advanced Non-Small Cell Lung Carcinoma

Conditions
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Lung Cancer

Intervention / Treatment
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* Dietary Supplement: mistletoe extract


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: mistletoe extract|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV non-small cell lung cancer, stage IIIB non-small cell lung cancer