Low Dose Arsenic Trioxide as a Potential Chemotherapy Protector
Fjalë kyçe
Abstrakt
Datat
Verifikuar së fundmi: | 10/31/2017 |
Paraqitur së pari: | 06/16/2011 |
Regjistrimi i vlerësuar u dorëzua: | 08/31/2011 |
Postuar së pari: | 09/01/2011 |
Përditësimi i fundit i paraqitur: | 11/12/2017 |
Përditësimi i fundit i postuar: | 12/12/2017 |
Data e paraqitjes së rezultateve të para: | 06/17/2014 |
Data e paraqitjes së parë të rezultateve të QC: | 06/17/2014 |
Data e rezultateve të para të postuara: | 07/17/2014 |
Data e fillimit të studimit aktual: | 03/31/2011 |
Data e vlerësuar e përfundimit primar: | 12/31/2012 |
Data e vlerësimit të përfundimit të studimit: | 12/31/2012 |
Gjendja ose sëmundja
Ndërhyrja / trajtimi
Drug: Arsenic Trioxide
Faza
Grupet e krahëve
Krah | Ndërhyrja / trajtimi |
---|---|
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). |
Kriteret e pranimit
Moshat e pranueshme për studim | 18 Years Për të 18 Years |
Gjinitë e pranueshme për studim | All |
Pranon Vullnetarë të Shëndetshëm | po |
Kriteret | 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. |
Rezultati
Masat Kryesore të Rezultateve
1. Dose of Arsenic That Blocks Activation of p53 [Day 1 of chemotherapy]
Masat dytësore të rezultateve
1. Complete Blood Count (CBC) [Day 9 of chemotherapy]