NCT00356980已完成1 期
A Phase I Trial of TNF-Bound Colloidal Gold (CYT-6091) by Intravenous Administration in Subjects With Advanced Solid Organ Malignancies
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose of TNF-bound colloidal gold (CYT-6091)
研究概览
简要总结
RATIONALE: Biological therapies, such as TNF-bound colloidal gold, may stimulate the immune system in different ways and stop tumor cells from growing.
PURPOSE: This phase I trial is studying the side effects and best dose of TNF-bound colloidal gold in treating patients with advanced solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of TNF-bound colloidal gold (CYT-6091) in patients with advanced solid tumors.
- Determine the toxicities of CYT-6091 in these patients.
Secondary
- Determine the pharmacokinetics of CYT-6091 in these patients.
- Evaluate biopsy samples of tumor and adjoining normal tissue for levels of CYT-6091.
- Determine if antitumor effects of CYT-6091 occur in 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed solid tumor
- •Advanced and/or metastatic disease
- •Unresponsive to conventional therapy (i.e., disease progressed while receiving any known standard curative or palliative therapy) OR previously untreated tumor for which no standard treatment exists
- •Measurable or evaluable metastatic disease
- •No lymphoma or other hematologic malignancy
- •No known brain metastases
- •Previously treated brain metastases with no evidence of recurrence allowed
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy ≥ 3 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 ≤ 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases are present)
- •Alkaline phosphatase ≤ 1.5 times ULN (3 times ULN if liver metastases are present)
- •Prothrombin time ≤ 1.5 times ULN
- •Hemoglobin ≥ 10.0 g/dL (transfusion allowed)
- •LVEF ≥ 45% by echocardiogram or thallium stress test for patients > 50 years of age or history of cardiovascular disease
- •FEV_1 and DLCO > 30% of predicted for patients with a history of pulmonary disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active bacterial or viral infection with systemic manifestations (e.g., fever, symptoms, leukocytosis)
- •Localized chronic infections, such as mild acne or tinea pedis allowed
- •No acute or chronic viral hepatitis
- •No known bleeding disorder
- •No other concurrent life-threatening illness, including any of the following:
- •Unstable angina
- •Severe oxygen-dependent chronic obstructive pulmonary disease
- •End-stage liver disease
- •No known active renal disease or renal insufficiency as evidenced by serum creatinine > 2.0 mg/dL
- •No HIV positivity
- •PRIOR CONCURRENT THERAPY:
- •Recovered from prior therapy
- •More than 3 weeks since prior biological or cytotoxic agents (6 weeks for nitrosoureas)
- •No known requirment for palliative treatment
- •No concurrent surgery
- •No other concurrent anticancer therapy
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose of TNF-bound colloidal gold (CYT-6091)
Toxicity
次要结局
- Pharmacokinetic profile of CYT-6091
- Measurements of CYT-6091 in tumor biopsies
- Tumor biopsy histology and gene expression after treatment
- Immunogenicity of CYT-6091
- Electron microscopy of biopsy to determine presence of colloidal gold
- Response of target and nontarget lesions
- Overall response
- Duration of response
- Duration of stable disease
研究者
研究点 (2)
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