Mistletoe in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Are Receiving Palliative Chemotherapy
This trial is active, not recruiting.
|Sponsor||Kimmel Cancer Center (KCC)|
|Collaborator||National Cancer Institute (NCI)|
|Start date||October 2002|
|Trial identifier||NCT00052325, CDR0000258166, TJUH-01F.45, TJUH-2001-35|
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.
Male or female participants at least 18 years old.
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)
|Official title||Iscar For Supplemental Care In Advanced Non-Small Cell Lung Carcinoma|
|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|
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