NCT00026533已完成2 期
Phase II Trial of Thalidomide for Therapy of Radioiodine-Unresponsive Papillary and Follicular Thyroid Carcinomas and Medullary Thyroid Carcinomas
Kenneth Ain1 个研究点 分布在 1 个国家开始时间: 2001年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Thalidomide may stop the growth of thyroid cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness thalidomide in treating patients who have thyroid cancer.
详细描述
OBJECTIVES:
- Determine the antitumor activity of thalidomide, in terms of tumor response and duration of response, in patients with metastatic follicular, papillary, or medullary thyroid carcinoma that is unresponsive to systemic radioiodine.
- Compare the differences in antitumor activity of this drug in patients with medullary carcinomas vs those with papillary or follicular carcinomas.
- Determine the toxic effects and duration of toxic effects of this drug in these patients.
OUTLINE: Patients receive oral thalidomide once daily for 2 weeks and then twice daily. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed follicular, papillary, insular, or medullary thyroid carcinoma
- •Must meet criteria for 1 of the following:
- •Unresectable, distantly metastatic tumor that does not concentrate radioactive iodine
- •Follicular or papillary thyroid carcinoma with a large distant tumor burden that has not sufficiently responded to cumulative iodine I 131 doses exceeding 800 mCi
- •Radiographic evidence of tumor progression, meeting 1 of the following criteria:
- •Evidence gathered over a period of at least 1 year with at least 3 separate x-ray studies, defining tumor volume
- •Similar radiographic evidence over a shorter period of time, delineating more than 30% increase in tumor volume
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 750/mm^3
- •Hemoglobin at least 10.5 g/dL
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •Creatinine no greater than 1.5 times ULN
- •BUN no greater than 1.5 times ULN
- •No active infection not controlled with medications
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective double contraception (1 hormonal method plus 1 barrier method OR 2 simultaneous barrier methods) for female patients or barrier contraception for male patients for more than 4 weeks prior to, during, and for at least 4 weeks after study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior thalidomide
- •No other concurrent biologic therapy
- •Chemotherapy:
- •At least 4 weeks since prior systemic chemotherapy
- •No concurrent systemic chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •Prior radiotherapy allowed
- •Concurrent limited external-beam radiotherapy to isolated sites of bony metastases allowed, provided that these sites are not the sole sites of metastatic disease and do not constitute the sites of evaluable disease for this study
- •No concurrent radioiodine therapy
- •See Disease Characteristics
- •Prior surgery allowed
- •Concurrent surgery allowed to sites that do not constitute evaluable disease for this study
- •No concurrent medications that are known to increase the risk of peripheral neuropathy
排除标准
- 未提供
研究者
Kenneth Ain
Sponsor/PI
University of Kentucky
研究点 (1)
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