NCT00118248已完成2 期
A Phase II Trial of 17-Allylaminogeldanamycin (17AAG) in Advanced Medullary and Differentiated Thyroid Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Proportion of Patients Who Have Remained on Treatment and Progression-free at Least One Year After Start of 17-AAG (Tanespimycin)
研究概览
简要总结
This phase II trial is studying how well tanespimycin works in treating patients with inoperable locoregionally advanced or metastatic thyroid cancer. Drugs used in chemotherapy, such as tanespimycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
详细描述
PRIMARY OBJECTIVES:
I. Determine the 1-year treatment failure rate in patients with inoperable locoregionally advanced or metastatic medullary or differentiated thyroid carcinoma treated with 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) (tanespimycin).
SECONDARY OBJECTIVES:
I. Determine the toxicity of this drug in these patients. Determine the 1-year progression-free rate in patients treated with this drug.
II. Determine the response rate and duration of response in patients treated with this drug.
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
- •Diagnosis of thyroid carcinoma of 1 of the following types:
- •Medullary
- •Differentiated
- •Iodine I 131-resistant disease, defined as failure to incorporate and/or progression of measurable disease after treatment with iodine I 131
- •Inoperable locoregionally advanced or metastatic disease
- •Measurable disease, defined as ≥ 1 lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
- •No active CNS metastases
- •Performance status - ECOG 0-2
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9.0 g/dL
- •Bilirubin ≤ normal
- •Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
- •AST ≤ 1.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •QTc < 450 msec for male patients (470 msec for female patients)
- •LVEF > 40% by MUGA
- •DLCO ≥ 80%
- •No cardiac symptoms ≥ grade 2
- •No active ischemic heart disease within the past year
- •No congenital long QT syndrome
- •No left bundle branch block
- •No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
- •No myocardial infarction within the past year
- •No New York Heart Association class III or IV congestive heart failure
- •No poorly controlled angina
- •No history of angina (of any sort) within the past 6 months
- •No history of uncontrolled dysrhythmias or requiring antiarrhythmic drugs
- •No history of cardiac toxicity after treatment with anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or carmustine)
- •No other significant cardiac disease
- •No uncontrolled infection
- •No history of serious allergic reaction to eggs
- •No pulmonary symptoms ≥ grade 2
- •No symptomatic pulmonary disease requiring medication including the following:
- •Dyspnea on or off exertion
- •Paroxysmal nocturnal dyspnea
- •Oxygen requirement
- •Significant pulmonary disease (e.g., chronic obstructive/restrictive pulmonary disease)
- •No home oxygen need meeting the Medicare criteria
- •No history of pulmonary toxicity after treatment with anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or carmustine)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma
- •No active seizure disorder
- •More than 4 weeks since prior and no concurrent immunotherapy
- •More than 4 weeks since prior biologic therapy
- •No concurrent routine or prophylactic colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
- •More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
- •No other concurrent chemotherapy
- 另有 10 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (chemotherapy)
Experimental
Patients receive tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: tanespimycin (Drug)
结局指标
主要结局
Proportion of Patients Who Have Remained on Treatment and Progression-free at Least One Year After Start of 17-AAG (Tanespimycin)
时间窗: 1 year
The one-year treatment failure free rate is 100% times the proportion of eligible patients who remain on treatment and are progression-free at least one year after treatment start. A 90% confidence interval for the one year treatment failure free rate was constructed using the properties of the binomial confidence interval. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are not classified as having a progression are termed progression-free.
次要结局
- Overall Survival(Every 3 months until progression, and then every 6 months up to 3 years)
- Toxicity(Every 3 courses during treatment (median cycle number was 5 with a maximum of 38 cycles))
- Overall Response(Baseline, every 3 courses, and at the end of treatment study)
- Progression-Free Survival(Every 3 months for up to 3 years)
研究者
研究点 (1)
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