NCT00052325Unknown2 期
Iscar For Supplemental Care In Advanced Non-Small Cell Lung Carcinoma
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University2 个研究点 分布在 1 个国家开始时间: 2002年10月1日最近更新:
适应症
试验速览
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •18 and over
- •Performance status
- •Karnofsky 60-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Not pregnant
- •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
- •Not specified
- •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)
排除标准
- 未提供
研究者
研究点 (2)
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