A Phase II Clinical and Biological Study of Lithium Carbonate in Patients With Low-Grade Neuroendocrine Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 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
The purpose of this study is to learn more about the effectiveness and side effects of lithium treatment for subjects with low-grade neuroendocrine tumors.
详细描述
Lithium 300mg by mouth, three times daily, escalating to a lithium level of 0.8-1.0; Continue until progressive disease/unacceptable toxicity;Evaluate q 8 weeks.
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
- 否
入选标准
- •Must have histologically confirmed metastatic low-grade neuroendocrine neoplasms. Small cell lung cancers, paragangliomas and pheochromocytomas are excluded. Pathologic diagnosis must be confirmed at the University of Wisconsin Carbone Cancer Center (UWCCC). Grading must be confirmed by pathologic review performed at UWCCC.
- •Must have measurable disease
- •Must have radiographic evidence of disease progression following any prior systemic therapy, chemoembolization, bland embolization, surgery, or observation.
- •Must be ≥ 4 weeks from the completion of major surgery, chemotherapy, or other systemic therapy or local liver therapy to study registration
- •Must be ≥ 3 weeks from the completion of radiation therapy to study registration
- •The following laboratory values are to be obtained within 14 days prior to registration: Absolute neutrophils count (ANC) ≥ 1000/mm3; Platelets ≥ 75,000/mm3; Hemoglobin ≥ 8.0 g/dL; Total bilirubin less than or equal 2.0 X the upper limit of normal (ULN); AST less than or equal to 3 X ULN or less than or equal 5 X ULN if liver metastases are present; Creatinine less than or equal ULN; Serum sodium within normal limits
- •Capable of understanding the investigational nature, potential risks and benefits fo the study and able to provide valid informed consent.
- •Must have available tissue specimens to be analyzed for pathologic confirmation.
- •Age ≥ 18 years.
- •Women must not be pregnant or lactating.
- •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 derivatives.
- •Patients are not allowed to be on concurrent chemotherapy or radiation therapy.
- •Patients are excluded if they have any of the following:
- •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.
- •History of hypothyroid disease Significant, active cardiac disease
- •Patients must not be taking the following medications: diuretics, ACE inhibitors, NSAIDs (except aspirin or sulindac), neuroleptics, tetracycline, COX2 (cyclooxygenase-2) inhibitors, citalopram, clovoxamine, escitalopram, femoxetine, fluoxetine, fluvoxamine, paroxatine, sertraline, and zimeldine.
- •Must be willing to undergo a tumor biopsy pre and post therapy.
- •Patients with a concurrent malignancy are allowed on study as long as the patient is not undergoing active treatment for their disease.
- •Patients already taking Lithium for any reason are not allowed on study.
排除标准
- 未提供
研究组 & 干预措施
Lithium
Lithium carbonate will be dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate will be provided as a 300mg tablet and will be taken daily without breaks in treatment.
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: Up to 4 years
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>=20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), small changes that do not meet the above criteria.
次要结局
- Overall Survival (OS)(Up to 4 years)
- Progression Free Survival (PFS)(Up to 4 years)