NCT03099356招募中2 期
An Open Label Phase II Trial Evaluating the Efficacy of Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Percentage of patients that respond to treatment
研究概览
简要总结
This study will be a non-randomized pilot trial using Cyclophosphamide and Sirolimus for the treatment of metastatic differentiated thyroid cancer. Patients will be treated with Sirolimus 4 mg, PO, days 1-28 as well as Cyclophosphamide 100 mg, PO, days 1-5 and 15-19. Cycle length will be 28 days. Patients will be monitored closely for toxicity and undergo imaging to evaluate efficacy once every 2 cycles.
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
- •Histologically documented differentiated thyroid cancer with or without metastases, not amenable to curative treatment; or the patient has documented refusal of curative treatment
- •Measurable disease (>10 mm) and have progression of disease based on RECIST criteria. Previously irradiated tumor lesions are not considered measurable unless they have progressed since radiation.
- •Previous failure of Iodine-131 (131I) therapy or not candidates to receive 131I as assessed by treating physician.
- •Age ≥ 18 years
- •ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- •Life expectance of ≥ 12 weeks
- •131I therapy not allowed within 24 weeks before entry (4 weeks if negative post-treatment scan)
- •Adequate organ and marrow function
- •Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to treatment
- •Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
- •Willingness and ability to comply with scheduled visits, treatment plans, including willingness to take study medication, laboratory tests, and other study procedures
排除标准
- •Inability to obtain Foundation One testing on archival tissue, or, lack of previous Next Generation Sequencing
- •Chemotherapy, tyrosine kinase inhibitor, or radiation therapy within 4 weeks
- •Prior experimental therapy within 4 weeks of planned start of this trial
- •131I therapy within 24 weeks before entry (4 weeks if negative post-treatment scan)
- •Previous treatment with an mTOR inhibitor
- •Patients who are currently receiving treatment with strong inhibitors or inducers of CYP3A4 or P-glycoprotein that cannot be discontinued at least one week prior to the start of treatment with Cyclophosphamide and Sirolimus
- •Impairment of GI (gastrointestinal) function or GI disease that may significantly alter the absorption of study medications (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection) including dependence on a G-Tube for administration of medications.
- •A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment
- •Patients with known sensitivities to either cyclophosphamide and/or sirolimus
- •Patients with known urinary outflow obstruction
- •Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol
- •Patients (male and female) having procreative potential who are not willing or not able to use adequate contraception or practicing abstinence
- •Women who are pregnant or breast-feeding
- •Patients residing in prison
研究组 & 干预措施
Cyclophosphamide and Sirolimus
Experimental
Sirolimus 4 mg, PO, days 1-28 as well as Cyclophosphamide 100 mg, PO, days 1-5 and 15-19
干预措施: Cyclophosphamide (Drug)
Cyclophosphamide and Sirolimus
Experimental
Sirolimus 4 mg, PO, days 1-28 as well as Cyclophosphamide 100 mg, PO, days 1-5 and 15-19
干预措施: Sirolimus (Drug)
结局指标
主要结局
Percentage of patients that respond to treatment
时间窗: Patients will be followed for response until progression or up to 2 Years
The primary measure of efficacy will be the overall response rate (ORR) which is defined as those achieving either complete response (CR) or partial response (PR). Partial response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Complete response is defined as Disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart (there can be no appearance of new lesions) and the disappearance of all non-target lesions and normalization of tumor marker level.
次要结局
- The number of patients that experience toxicity(Patients are followed for toxicity up to 30 days after the last dose of study drug)
- Median overall survival time(Patients will be followed until death or up to 2 years)
- Median progression free survival time(Patients will be followed for response until progression or up to 2 Years)
研究者
研究点 (2)
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