NCT00442533已完成2 期
High Dose Indium-111 Pentetreotide Therapy in Somatostatin Receptor Expressing Neuroendocrine Neoplasms.
Radio Isotope Therapy of America2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2005年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in solid tumor dimensions by CT scan.
研究概览
简要总结
The purpose of this study is to determine if High-dose 111In-Pentetreotide known as NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.
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
- •Patients must have received first line standard chemotherapy and/or radiation therapy for neuroendocrine malignancy in the past and failed the therapy.
- •Patients must have evidence of residual multifocal active tumor.
- •All patients must sign an informed consent indicating the awareness of the investigational nature of the studies involved.
- •All patients must have a Karnofsky performance status of at least
- •Patients must be greater than 18 years of age.
- •Patients must have measurable and/or followable disease based on either clinical or radiologic exam.
- •Sensitivity to Indium-111 pentetreotide or any of its components is an absolute contraindication to participation in this trial.
- •An absolute contraindication is pregnancy as evidenced by the clinical condition, a positive pregnancy test (Beta type Human chorionic gonadotropin (β-HCG) or pelvic ultrasound).
- •If patients have received prior radionuclide therapy of the same product, there must be documented response to that therapy and/or residual active stable disease.
排除标准
- •Karnofsky performance status of 50 or less.
- •Patients who are unable to give informed consent.
- •Patients under 18 years of age. There will be no upper age discrimination.
- •Patients who are pregnant or those potentially pregnant subjects not willing to practice effective contraceptive techniques during the study period.
- •Patients with renal insufficiency as defined by a calculated creatinine clearance (based on age, weight and serum creatinine) of 39.9 ml/min or less.
研究组 & 干预措施
Indium-111 pentetreotide
Experimental
4 cycles of 500 mCi treatments every 10-12 weeks
干预措施: Indium-111 pentetreotide (Drug)
结局指标
主要结局
Change in solid tumor dimensions by CT scan.
时间窗: Baseline to post treatment CT scan performed 2-4 days after each cycle and 12and 24 weeks after treatments
Change in diameters of measurable lesions on CT using RECIST. and will be classified into 4 groups. 1. Complete response 2. Partial response 3. No change or stable disease 4. Progression
次要结局
- Frequency and severity of adverse events(up to 6 months following the last cycle of therap)
研究者
Ebrahim Delpassand
President and CEO
Radio Isotope Therapy of America
研究点 (2)
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