Phase II Study of Sunitinib Malate in Refractory Germ Cell Tumors
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- 12 Week Progression Free Survival Rate in Refractory Germ Cell Tumors Treated With Sunitinib Malate
研究概览
简要总结
The goal of this clinical research study is to learn if Sutent® (sunitinib malate, SU011248) can control the disease in patients with germ cell tumors that are resistant to earlier treatment.
详细描述
The Study Drug:
Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer.
Within 14 days of enrollment on this study, you will have the following tests and procedures performed:
- Your complete medical history will be recorded.
- You will have a physical exam.
Within 7 days of enrollment on this study, you will have the following tests and procedures performed:
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Progressive metastatic Germ-cell tumors (GCTs) of gonadal or extragonadal origin in males after failure of front-line therapy and at least one salvage regimen.
- •Must have evaluable or measurable disease by clinical or radiological studies. Alternatively, in the absence of radiologically evaluable or measurable disease, two sequentially rising marker values each one week apart attributed by treating physician to germ cell tumor is permitted; either beta human chorionic gonadotropin (hCG) above 50 mIU/ml and/or alpha-fetoprotein (AFP) above 20 ng/ml qualifies as eligible.
- •The Eastern Cooperative Oncology Group (ECOG) Performance Score 0-2
- •Adequate organ function as follows: Calculated creatinine clearance >/= 35cc/min, Absolute neutrophil count >/= 1500/mm^3, hemoglobin >/= 8 g/dL, serum calcium </= 12 mg/dL, Platelet count >/= 75,000/mm^3, AST (SGOT)/ALT (SGPT) < 2.5 x upper limit of normal (ULN), Total bilirubin < 2.0mg/dl.
- •Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 grade </=
- •At least 18 years of age as safety of sunitinib in a pediatric population has not been established.
- •Able to provide informed consent
- •Must be able to ingest oral medication
- •Male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
- •Patients who have not received prior high-dose chemotherapy and stem cell rescue as salvage therapy will have this option discussed with them. Only patients ineligible, unwilling or unable to undertake this option will be eligible for this trial.
排除标准
- •NCI CTCAE Version 3.0 grade 3 hemorrhage within the 4 weeks prior to starting the study treatment.
- •Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
- •Patients with history of Long QT syndrome.
- •Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade >/=
- •Uncontrolled Hypertension (> 140/90 mm Hg despite optimal medical therapy).
- •Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
- •Symptomatic bowel obstruction.
- •Prior VEGFR/PDGFR inhibitor therapy.
- •Known human immunodeficiency virus infection, chronic active hepatitis or liver cirrhosis.
研究组 & 干预措施
Sunitinib Malate
Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
干预措施: Sunitinib Malate (Drug)
结局指标
主要结局
12 Week Progression Free Survival Rate in Refractory Germ Cell Tumors Treated With Sunitinib Malate
时间窗: 12 weeks
Measurable disease or response recorded from start of treatment until disease progression/recurrence. Participants who die during therapy or are lost to follow-up shall be counted as progressive disease. Progressive disease defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Evaluation of measurable disease response follows Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
次要结局
未报告次要终点