Low Dose Arsenic Trioxide as a Potential Chemotherapy Protector
关键词
抽象
日期
最后验证: | 10/31/2017 |
首次提交: | 06/16/2011 |
提交的预估入学人数: | 08/31/2011 |
首次发布: | 09/01/2011 |
上次提交的更新: | 11/12/2017 |
最近更新发布: | 12/12/2017 |
首次提交结果的日期: | 06/17/2014 |
首次提交质量检查结果的日期: | 06/17/2014 |
首次发布结果的日期: | 07/17/2014 |
实际学习开始日期: | 03/31/2011 |
预计主要完成日期: | 12/31/2012 |
预计完成日期: | 12/31/2012 |
状况或疾病
干预/治疗
Drug: Arsenic Trioxide
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: Arsenic Trioxide | Drug: Arsenic Trioxide IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received). |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: 1. Patients ≥ 18 years of age with the diagnosis of malignancy other than leukemia who are to start chemotherapy known to suppress peripheral blood counts. The expected interval between each cycle of chemotherapy should be a minimum of 2 weeks. The minimum number of planned chemotherapy cycles should be 4. Radiation therapy during chemotherapy is allowed as long as less than 10% of the total bone marrow is radiated. 2. Present with or without previous treatment for the disease. 3. ECOG (Eastern Cooperative Oncology Group) performance status = 2 (see Appendix B). 4. Life expectancy of greater than 6 months 5. Organ functions as deemed appropriate for chemotherapy per standard of care 6. Agree to use adequate contraception prior to study entry and for the duration of study participation. 7. Ability to understand and the willingness to sign a written informed consent document. 8. No baseline p53 activation in peripheral lymphocytes in culture but p53 activation should be inducible upon radiation with 2 Gy in culture Exclusion Criteria: 1. History of allergic reactions attributed to Arsenic Trioxide 2. Experiencing uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 3. Pregnant 4. HIV-positive patients and taking combination antiretroviral therapy. 5. History of having circulating malignant cells if the patient has lymphoma or myeloma 6. Impaired cardiac function or clinically significant cardiac diseases, including any of the following: history of long QT syndrome; mean QTc (corrected QT interval) > 500 msec on screening EKG; history of clinically manifest ischemic heart disease including myocardial infarction; stable or unstable angina, coronary arteriography or cardiac stress testing/imaging with findings consistent with coronary occlusion or infarction < 6 months prior to study start; history of heart failure or left ventricular (LV) dysfunction (LVEF < 45%) by MUGA or ECHO; clinically significant EKG abnormalities including one or more of the following: left bundle branch block (LBBB), right bundle branch block (RBBB) with left anterior hemiblock (LAHB). ST segment elevations or depressions > lmm, or 2nd (Mobitz 11) or 3rd degree AV block; history or presence of atrial fibrillation, atrial flutter or ventricular arrhythmias including ventricular tachycardia or Torsades de Pointes; other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen); clinically significant resting bradycardia (< 50 beats per minute); obligate use of a cardiac pacemaker. |
结果
主要结果指标
1. Dose of Arsenic That Blocks Activation of p53 [Day 1 of chemotherapy]
次要成果指标
1. Complete Blood Count (CBC) [Day 9 of chemotherapy]