Phase I Safety and Dosimetry Study in Patients With Confirmed Metastatic Melanoma
2011年10月7日 更新者:Molecular Insight Pharmaceuticals, Inc.
A Phase I Study Evaluating the Safety, Pharmacokinetics, Tissue Distribution, and Determination of Radiation Dosimetry for 131-I-MIP-1145
This is an open-label, single dose study for patients 18 years of age or older with confirmed metastatic melanoma.
Up to 12 patients will be enrolled and all will receive an injection of approximately 4.0 to 6.0 mCi (148-222 MBq) of 131-I-MIP-1145 administered via IV injection.
The study will consist of a single dosing day followed by a 7-day assessment period and 21-day follow-up period.
The total duration of the study from screening to final follow-up visit is approximately 60 days.
研究概览
研究类型
介入性
注册 (预期的)
12
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104-4283
- Hospital of the University of Pennsylvania
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Provide written informed consent and be willing to comply with all protocol requirements
- Men and women 18 years of age or older
Female patients must meet 1 of the following criteria:
- not be of childbearing potential as documented by medical history (e.g., tubal ligation or hysterectomy), or be post menopausal with a minimum 1 year without menses
- Have a negative serum beta human chorionic gonadotropin (BHCG) pregnancy test within 48 hours prior to receiving the test article and agree to use a medically acceptable form of birth control, defined as abstinence or use of an intrauterine device (IUD), oral contraceptive, barrier and spermicide, or hormonal implant throughout the 28 day study period.
- Male patients of childbearing potential must agree to use at least one of the following medically acceptable forms of birth control throughout the 28 day study period; abstinence, barrier or other acceptable, effective contraceptive method.
- Historical diagnosis (surgical or histological) of primary melanoma with metastatic melanoma confirmed by histology and/or radiologically via MRI/CT.
- CT/MRI representing current measurable metastatic lesion (within 6 to 12 weeks of entry; at least one lesion > 2cm in the longest dimension)
Exclusion Criteria:
- Less than 18 years of age
- Pregnant or breastfeeding
- Inadequate venous access (defined as contralateral antecubital or equivalent venous access sites which are required for study drug injection and PK blood sampling, respectively)
- Uncontrolled glaucoma or retinopathy (e.g. macular degeneration) treated in the past year
- Cataracts or other lens opacities
- Any ophthalmologic intervention within the last 30 days (e.g., cataract extraction, laser procedure or equivalent, anti-VEGF treatment for macular degeneration. Topical treatments including antibiotics for conjunctivitis are allowed.)
- Patient received external beam therapy or chemotherapy within the last 30 days
- Any history of head and neck radiotherapy
- Karnofsky performance status is less than 60 (ECOG status > 2)
- Serum creatinine is greater or equal to 2.0 mg/dL
- Total bilirubin greater or equal to 1.5 times upper limit of normal
- SGOT/AST or SGPT/ALT greater or equal to 3 times upper limit of normal (patients with metastatic liver disease are eligible if transaminase elevation is > 5 times the upper limit of normal)
- Received an investigational compound and/or medical device within 30 days before admission into this study
- Administered a 99mTc-labeled radioisotope < 3 days prior to imaging or < 7days prior to imaging for other diagnostic radioisotopes with half lives greater than 24 hours
- Any known allergy or sensitivity to iodine. Iodinated X-ray contrast hypersensitivity is not an exclusion.
- Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-injection follow-up examinations
- Determined by the Investigator to be clinically unsuitable for the study
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
研究衡量的是什么?
次要结果测量
结果测量 |
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To estimate radiation absorbed doses (dosimetry) to known 131-I-MIP-1145 avid lesions and to the whole body, following a single bolus (IV) injection of approximately 4.0 to 6.0 mCi (148-222 MBq) of 131-I-MIP-1145.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年12月1日
初级完成 (实际的)
2011年9月1日
研究完成 (实际的)
2011年9月1日
研究注册日期
首次提交
2008年9月4日
首先提交符合 QC 标准的
2008年9月4日
首次发布 (估计)
2008年9月5日
研究记录更新
最后更新发布 (估计)
2011年10月12日
上次提交的符合 QC 标准的更新
2011年10月7日
最后验证
2011年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
131-I-MIP-1145的临床试验
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