NCT00582712终止2 期
An Initial Study of Lithium in Patients With Medullary Thyroid Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
研究概览
简要总结
Primary objective is to evaluate the tumor response rate of patients with MTC treated with Lithium carbonate
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Histologically confirmed MTC with signs of residual/persistent disease based on tumor marker levels and/or radiographic imaging. Pathologic diagnosis must be confirmed at UWCCC. Grading must be confirmed by pathologic review performed at UWCCC.
- •Elevated neuroendocrine markers at least 1 month post -op. In MTC, persistently elevated neuroendocrine markers such as calcitonin and CEA are indicative of persistent disease.
- •Disease progression is not required for this trial
- •4 weeks from the completion of major surgery, chemotherapy, or other systemic therapy or local liver therapy to study registration. Subjects will have had standard of care prior to enrollment. Subjects will have had standard of care prior to enrollment (for example it could include total thyroidectomy, central lymph node dissection, and when necessary ipsilateral radical neck dissection but is tailored to the patient).
- •3 weeks from the completion of radiation therapy to study registration
- •The following laboratory values obtained within 14 days prior to registration:
- •Absolute neutrophils count (ANC) ≥ 1000/mm3
- •Platelets ≥ 75,000/mm3
- •Hemoglobin ≥ 8.0 g/dL
- •Total bilirubin greater than or equal to 2.0 X the upper limit of normal (ULN)
- •AST greater than or equal to 3 X ULN or greater than or equal to 5 X ULN if liver metastases are present
- •Creatinine greater than or equal to ULN
- •Serum sodium within normal limits
- •ECOG performance status of 2
- •Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
- •Availability of tissue specimens to be analyzed for pathologic confirmation.
- •Age ≥ 18 years.
- •Women must not be pregnant or lactating due to the deleterious effects of Lithium carbonate on a fetus or small child. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy.
- •Women of childbearing potential and sexually active males are required to use an accepted and effective method of contraception.
- •Patients must not have known history of allergic reactions or adverse reactions to Lithium or its derivatives.
- •Patients are not allowed to be on concurrent chemotherapy or radiation therapy.
排除标准
- •Gastrointestinal tract disease resulting in an inability to take oral medication (i.e. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, bowel obstruction, or inability to swallow the tablets).
- •Significant, active cardiac disease
- •Patients must not be taking the following medications: diuretics, ACE inhibitors, NSAIDs (except aspirin or sulindac), neuroleptics, tetracycline, and COX2 inhibitors.
- •Patients with radiographic evidence of disease will be presented the option to undergo a tumor biopsy although this is not mandatory.
- •Patients already taking Lithium for any reason are not allowed on study
研究组 & 干预措施
Lithium Capsules
Experimental
Lithium carbonate
干预措施: Lithium carbonate (Drug)
结局指标
主要结局
Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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