NCT00436410已完成早期 1 期
An Evaluation of the Tissue Distribution and the Selective Tumor Trafficking of TNF-Bound Colloidal Gold (CYT-6091) Following Intravenous Administration in Subjects With Primary and Metastatic Cancer Undergoing Surgical Resection
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 4
- 主要终点
- Tumor tissue and normal tissue distribution of colloidal gold-bound tumor necrosis factor
研究概览
简要总结
RATIONALE: Biological therapies, such as tumor necrosis factor, may stimulate the immune system in different ways and stop tumor cells from growing. Studying tumor necrosis factor in samples of tumor tissue and healthy tissue from patients with cancer in the laboratory may help doctors learn how tumor necrosis factor works in tumor tissue and healthy tissue.
PURPOSE: This clinical trial is studying tumor necrosis factor in patients undergoing surgery for primary cancer or metastatic cancer .
详细描述
OBJECTIVES:
Primary
- Determine the tumor tissue and normal tissue distribution of colloidal gold-bound tumor necrosis factor in patients with primary or metastatic cancer undergoing surgery.
Secondary
- Determine, by histological examination of resected tumor tissue, the acute antitumor effects of this treatment in these patients.
- Determine the long-term toxicities of this treatment in these patients.
- Determine the response to this treatment in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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:
- •Histologically confirmed primary or metastatic malignancy, including any of the following:
- •Colorectal cancer
- •Hepatocellular cancer
- •Pancreatic exocrine cancer
- •Pancreatic endocrine cancer
- •Breast cancer
- •Primary adrenal tumors
- •Renal cell carcinoma
- •Ovarian cancer
- •Adenocarcinoma of gastrointestinal origin
- •Peritoneal mesothelioma
- •Clinical indication for surgical resection
- •No known brain metastases
- •Previously treated brain metastases with no evidence of recurrence allowed
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Male or female
- •Menopausal status not specified
- •ECOG performance status 0-2
- •Life expectancy ≥ 5 months
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Creatinine ≤ 2.0 mg/dL
- •Bilirubin ≤ 2.5 mg/dL
- •ALT and AST ≤ 3 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 3 times ULN
- •Hemoglobin ≥ 9.0 g/dL
- •Ejection fraction ≥ 45% by echocardiogram, thallium stress test, or MUGA (for patients with prior cardiovascular disease)
- •FEV_1 OR DLCO > 30% of predicted (for patients with prior pulmonary disease)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active bacterial infection
- •Localized chronic infection (e.g., mild acne, tinea pedis) allowed
- •No known bleeding disorder
- •No other serious illness including, but not limited to, any of the following:
- •Unstable angina
- •Severe oxygen-dependent chronic obstructive pulmonary disease
- •End-stage liver disease
- •No HIV positivity
- •PRIOR CONCURRENT THERAPY:
- •Recovered from prior therapy, including cytotoxic drugs, radiotherapy, surgery, or other anticancer modalities
- •More than 3 weeks since prior biologic therapy or cytotoxic agents (6 weeks for nitrosoureas) and recovered
- •No concurrent treatment in a protocol for which patient is being evaluated for response
- •No other concurrent anticancer treatment
排除标准
- 未提供
结局指标
主要结局
Tumor tissue and normal tissue distribution of colloidal gold-bound tumor necrosis factor
Comparison of the impact of distribution time and histology on accumulation of treatment particles in tumor vs normal tissues
次要结局
- Acute antitumor activity of treatment
- Long-term toxicity of treatment as assessed by CTCAE v3.0
研究者
研究点 (4)
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