Lung Cancer
Conditions
Keywords
stage IV non-small cell lung cancer, stage IIIB non-small cell lung cancer
Brief 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 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
Interventions
DIETARY_SUPPLEMENTmistletoe extract
Sponsors
National Cancer Institute (NCI)
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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)
Countries
United States
Outcome results
None listed