NCT00560495撤回1 期
The Combination of Radiotherapy With the Anti-Angiogenic Agent Tetrathiomolybdate (TM) in the Treatment of Stage I-IIIB Non-Small Cell Lung Cancer (NSCLC): A Phase I Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Acute toxicity
研究概览
简要总结
RATIONALE: Ammonium tetrathiomolybdate may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving ammonium tetrathiomolybdate together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of giving radiation therapy together with ammonium tetrathiomolybdate in treating patients with stage I, stage II, or stage III non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To assess the acute toxicity of combining antiangiogenic copper reduction with ammonium tetrathiomolybdate (TM) and standard external-beam radiotherapy in patients with stage I-IIIB non-small cell lung cancer.
Secondary
- To measure changes in biological markers of angiogenesis (i.e., ELISA analysis of serum bFGF, VEGF, TGF-beta, IL-6, and IL-8) affected by TM or radiotherapy and an imaging technique (technetium 99m sestamibi) known to correlate with intratumoral angiogenesis.
- To follow the late toxicity that exists when angiogenic inhibition with the copper reduction agent TM is combined with standard external-beam radiotherapy in these patients.
- To collect tumor response, recurrence rate, and survival data on these patients.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting the following criteria:
- •Squamous, large cell undifferentiated, or adenocarcinoma
- •Sputum cytology not acceptable evidence of cell type
- •Cytologic specimens obtained by brushing, washing, or needle aspiration of a defined lesion allowed
- •Stage I-IIIB disease
- •No evidence of distant metastases
- •Planning to receive definitive radiotherapy alone or post-operative radiotherapy (for gross residual disease or positive margin)
- •Medically inoperable disease or chemotherapy or surgery refused
- •Mediastinal lymph nodes must be evaluated by either mediastinoscopy or by PET scan, unless definitive CT-positive mediastinal disease is noted
- •If patient cannot tolerate mediastinoscopy and no PET is available, the technetium 99m sestamibi scan is allowed for assessment of the mediastinum
- •No stage IIIB disease with pleural effusions or stage IV disease
- •No small cell lung cancer or mixed small cell/non-small cell histology
- •PATIENT CHARACTERISTICS:
- •SWOG performance status 0-2
- •Hemoglobin ≥ 9.0 g/dL
- •WBC ≥ 3,000/mm³
- •ANC ≥ 1,200/mm³
- •Platelet count ≥ 80,000/mm³
- •Creatinine < 1.8 mg/dL
- •Prior malignancy allowed if disease free for ≥ 5 years
- •Nonmelanoma skin cancer allowed within 5 years
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No grade 3 hemoptysis (or hemoptysis not requiring transfusion, but where the radiation oncologist has concerns about a 3-week delay in treatment)
- •No pneumonia due to bronchial obstruction (or a high-grade bronchial obstruction where the radiation oncologist has concerns about a 3-week delay in treatment)
- •No transfusion dependence requiring > 2 units of packed RBCs every 2 weeks for more than 28 days
- •No medically serious acute or chronic medical condition that is unstable and/or requires intensive management
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Prior thoracic radiation allowed if the new lesion can be treated with absolutely no overlap of previous treatment fields
- •At least 3 weeks since prior surgery
- •No concurrent chemotherapy
排除标准
- 未提供
结局指标
主要结局
Acute toxicity
次要结局
- Late toxicity
- Assessment of markers of angiogenesis on imaging (technetium 99m sestamibi) scans
- Collection of response, recurrence, and survival data(every 3 months for up to 2 years)
- Assessment of markers of angiogenesis in serum (VEGF, bFGF, TGF-beta, IL-6, IL-8)
研究者
研究点 (1)
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