Phase II Study of Histone Deacetylase Inhibitor SAHA (Vorinostat) in Patients With Metastatic Thyroid Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Objective Response Rate (PR + CR) Using RECIST/WHO Response Criteria
研究概览
简要总结
This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating patients with metastatic and/or locally advanced or locally recurrent thyroid cancer. Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
详细描述
PRIMARY OBJECTIVES:
I. Determine the objective response rate in patients with metastatic and/or locally advanced or locally recurrent thyroid cancer treated with suberoylanilide hydroxamic acid.
SECONDARY OBJECTIVES:
I. Determine the toxicity of this drug in these patients.
OUTLINE:
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 confirmed thyroid cancer
- •One of the following subtypes:
- •Papillary thyroid cancer
- •Follicular thyroid cancer
- •Hürthle cell thyroid cancer
- •Insular thyroid cancer
- •Medullary thyroid cancer
- •Mixed histology thyroid cancer
- •Poorly differentiated thyroid cancer
- •Tall-cell thyroid cancer
- •Metastatic and/or locally advanced or locally recurrent disease
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •Lesions in a previously irradiated area allowed provided there has been subsequent disease progression of the irradiated lesions
- •The following are not considered measurable disease:
- •Bone lesions
- •Leptomeningeal disease
- •Pleural or pericardial effusion
- •Lymphangitis cutis/pulmonis
- •Abdominal masses not confirmed and followed by imaging techniques
- •Cystic lesions
- •Not a candidate for radioactive iodine I^131 therapy
- •Performance status - ECOG 0-1
- •At least 6 months
- •WBC ≥ 3,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.5 mg/dL
- •AST and ALT ≤ 2.5 times upper limit of normal
- •Creatinine ≤ 1.5 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drug
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study compliance
- •No other uncontrolled illness
- •No other active malignancy except nonmetastatic nonmelanoma skin cancer or carcinoma in situ of the cervix
- •More than 4 weeks since prior systemic cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin)
- •No more than 2 prior chemotherapy regimens for the treatment of thyroid cancer
- •See Disease Characteristics
- •More than 4 weeks since prior external beam radiotherapy
- •At least 24 weeks since prior radioactive iodine I^131 therapy
- •Recovered from prior therapy
- •More than 4 weeks since prior valproic acid or any other histone deacetylase inhibitor
- •More than 4 weeks since prior investigational tumor-specific therapy
- •Concurrent oral or IV bisphosphonates for bony metastases allowed at the discretion of the investigator
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •No other concurrent tumor-specific or investigational therapy
- •No other concurrent anticancer therapy
- •No concurrent adjuvant therapy for another cancer
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.
干预措施: vorinostat (Drug)
结局指标
主要结局
Objective Response Rate (PR + CR) Using RECIST/WHO Response Criteria
时间窗: Up to 3 years
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.
次要结局
未报告次要终点