NCT00718770已完成早期 1 期
Rexinoid Therapy for Poorly Differentiated Thyroid Cancer: A Pilot Clinical Trial and Correlation to Retinoid and PPARy Receptor Expression
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Tumor Size
研究概览
简要总结
This study plans to learn more about a drug called bexarotene for the treatment of advanced thyroid cancer. Subjects are asked to be in this study because they have thyroid cancer that will not respond to radioactive iodine therapy and shows signs of aggressive behavior.
Bexarotene has been FDA approved for the treatment of a type of skin cancer called cutaneous T-cell lymphoma, but has not been FDA approved for this use. Bexarotene is investigational in the treatment of thyroid cancer.
The purpose of this research study is to test how well the study drug works in humans. The study doctors want to know if:
- The subjects thyroid cancer gets smaller while you are taking the study drug.
- The subjects thyroid cancer takes up radioactive iodine better after treatment with the study drug than before treatment.
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
- •Subject must have a histologically/cytologically confirmed diagnosis of papillary, follicular, or anaplastic thyroid cancer (any follicular cell derived thyroid cancer).
- •Subjects must have evidence of follicular cell-derived thyroid cancer progression. In patients with anatomically stable disease, PET positive lesions will also be eligible given the poor prognostic risk for PET positive thyroid cancer.
- •Subjects must not be eligible for surgical resection.
- •Subjects must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- •Subjects must have laboratory values that fall within certain ranges.
- •Subjects must be age 18 years or older.
- •Subjects must provide written informed consent prior to any study procedures being performed.
- •Females of childbearing potential must have a negative pregnancy test prior to enrollment.
- •All eligible subjects must be willing to use adequate contraception throughout the duration of the study.
- •Subjects must be willing to submit a primary tumor tissue sample for immunohistochemical analysis.
- •Subjects have the option of providing one additional test tube of blood taken at baseline, 6 months and 1 year for banking of plasma for potential future studies (no genetic testing will be conducted). The current planned analysis is for the assessment of a potential peripheral marker for rexinoid responsive cancer - leukemia inhibitory factor (LIF)
排除标准
- •Subjects with a known history of hyperlipidemia refractory to treatment.
- •Subjects with a known history of hypertriglyceridemia refractory to treatment.
- •Subjects with leukopenia below the reference range for the University of Colorado Hospital (UCH) laboratory.
- •Subjects, who are pregnant, have a desire to become pregnant or are breastfeeding.
- •Subjects who are unwilling or unable to comply with study medication administration, or study guidelines, as determined by the investigator.
- •Subjects with any prior history of malignancy with the exception of adequately treated basal cell skin cancer, in situ cervical cancer or other cancer for which the subject has been disease free for 3 years or more.
- •Subjects without radiographically assessable disease
研究组 & 干预措施
Bexarotene
Experimental
Open label - all patients receive intervention
干预措施: Bexarotene (Drug)
结局指标
主要结局
Change in Tumor Size
时间窗: 1 year
To assess the tumor response of recurrent or metastatic radioiodine resistant thyroid cancer to bexarotene therapy using standard RECIST criteria
次要结局
未报告次要终点
研究者
研究点 (1)
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