Phase I Trial of ZIO-101 in Patients With Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
Primary Objectives:
- To determine the toxicities and maximum tolerated dose (MTD) of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks in subjects with advanced solid tumors.
- To determine the pharmacokinetic profile of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks.
Secondary Objective:
- To determine the anti-tumor effects of ZIO-101.
详细描述
ZIO-101 is a drug that may change cancerous cells into healthy (benign) cells. It is also designed to cause cancer cells to destroy themselves; a term called apoptosis.
Before you can start treatment on this study, you will have what are called "screening tests" no more than one week before starting the study. These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam, including measurements of your weight, blood pressure, pulse, and temperature. You will also be asked what other medicines you are taking and about your general well-being. You will have an electrocardiogram (ECG - a test to measure the electrical activity of the heart). Blood (about 2 1/2 tablespoons) will be drawn. A sample of urine will be also be collected and tested to see if your kidneys are working correctly. Women who are able to have children must have a negative urine pregnancy test.
To see the current condition of your tumor, additional tests may need to be performed if they have not already been done recently. These tests may include a chest x-ray, a CT scan (imaging computer pictures of your body), a bone scan (an imaging test of your bones with a contrast material), or an MRI (a detailed imaging scan of certain areas of your body).
If you are found to be eligible to take part in this study, you will begin treatment with ZIO-101. Immediately before being treated with ZIO-101 on Day 0, you will have another physical exam and you will be asked about any medicines you are taking and how you are feeling. You will also be asked a series of questions which will assess your mental health. This is called a mini-mental status exam and will take approximately 10 minutes to complete. The blood tests may need to be repeated along with the ECG and the urine test. In addition, a small blood sample (about 10 teaspoons) must be taken immediately before the injection of ZIO-101. This blood will be used to help in the measurement of drug levels in the blood. These are called pharmacokinetic (PK) tests. This blood sample will also be used to measure arsenic levels in your blood.
ZIO-101 will be injected into your vein over 60 minutes in the clinical translational research center of UTMDACC. This drug must be given through a special IV called a central line catheter so that it does not damage your surrounding tissue. You will have to sign a separate consent document before placement of a catheter can be performed. Special care will be taken to be sure the drug does not leak into surrounding tissue. The use of anti-nausea and other supportive care medications may be given during the infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histological confirmation solid malignancy refractory to conventional standard therapies for their condition.
- •Eligible subjects MUST have at least one measurable lesion as defined by RECIST guidelines. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. Measurable lesions MUST not have been in a previously irradiated field or injected with biological agents.
- •Pediatric patients will be eligible at the discretion of the primary investigator.
- •ECOG performance status score </=
- •Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative blood or urine pregnancy test within 1 week before beginning treatment. Sexually active men must also use acceptable contraceptive methods.
- •Patients must provide written informed consent prior to treatment.
- •At least four weeks from completion of prior therapy to day 1 of study drug.
- •Baseline toxicity assessment less than or equal to grade 1 except treatment induced alopecia (NCI Common Terminology Criteria for Adverse Events [CTCAE] version 3.0).
- •Evidence of adequate multi-organ functional status as reflected by the following clinical laboratory values: - Serum creatinine </= 2 times the upper normal limit OR a calculated creatinine clearance </= 50 cc/min. - Total bilirubin </= 2 times the upper normal limit. - Alanine aminotransferase (ALT), OR aspartate aminotransferase (AST) </= 3 times the upper limit of normal.
- •Granulocytes in peripheral blood greater than or equal to 1 x 10(9) per liter, hemoglobin greater than or equal to 8.5 g/dL, and platelets greater than or equal to 50,000 cells/microL.
排除标准
- •Uncontrolled systemic infection (documented with microbiological studies).
- •Active heart disease as defined by an acute myocardial infarction within the previous 6 months before starting therapy, stable or unstable angina, clinically significant arrhythmia requiring medical management, OR New York Heart Association Classification of Functional Activities. Class 3: Patient has marked limitation in activities due to symptoms, even during less-than-ordinary activity and is comfortable only at rest OR Class 4: Severe limitations. Patient experiences symptoms even while at rest.
- •Concomitant therapy for solid cancer.
- •Pregnant subjects and those who are breast-feeding.
- •History of an invasive second primary malignancy diagnosed within the previous 3 years except for Stage I Endometrial/Cervical Carcinoma or Prostate Carcinoma treated surgically, and non-melanoma skin cancer.
- •Documented personal or family history of prolonged QT syndrome.
- •12 lead electrocardiogram with a corrected QT interval >/= 460 milliseconds.
- •History of confusion or dementia.
- •History of seizure disorder.
研究组 & 干预措施
ZIO-101
干预措施: ZIO-101 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: Daily for 5 consecutive days repeated every 4 weeks for 1 cycle; evaluation of 4-6 dose escalations to determine an MTD
次要结局
未报告次要终点