| Exclusion Criteria: | 1) Patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control (such as oral, implantable, or injectable contraceptives). (Women of childbearing potential must have a negative serum pregnancy test 72 hours prior to administration of RTA 744 Injection).
2) Total urinary protein in 24 hours urine collection > 500 mg.
3) Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study: (a)uncontrolled diabetes (patients diagnosed with Type 1 or Type 2 diabetes who are currently under treatment by a physician for this condition and are not able to control blood sugars with management for glucose levels above 250 mgs. per deciliter); (b)active or uncontrolled infection; (c)acute or chronic liver disease, (i.e., hepatitis, cirrhosis); or (d)confirmed diagnosis of HIV infection
4) Impaired cardiac function, major prior cardiac disease or arrhythmia: a) LVEF< 45 % as determined by MUGA scan/ECG; b) complete left bundle branch block; c) obligate use of a cardiac pacemaker; d) ST depression of >1mm in >/=2 leads and/or T wave inversions in >/=2 contiguous leads; e) congenital long QT syndrome; f) history/presence of ventricular/atrial tachyarrhythmias; g) clinically significant resting bradycardia (<50 bts/min); h) QTc >480 msec on screening ECG; i) uncontrolled high blood pressure, history of labile hypertension or of poor compliance with an antihypertensive regimen.
5) Patients with history of CHF or arrhythmias.
6) Patients who are taking therapeutic doses of warfarin sodium (Coumadin®).
7) Patients who have received the following types of prior or concurrent therapy, ow who have not recovered from the toxic effects of such therapy: (1) investigatonal drugs less than 4 weeks prior to entry on this study; (2) chemotherapy within 4 weeks prior (6 weeks for notrosourea or mitomycin-c or 2 weeks for vincristine) to entry on this study; (3) metronomic daily dosing of chemotherapy agents - patients may be enrolled 1 week after discontinuation of these agents as long as ANC returns to 1.0 x 10^9/L and platelet count returns to >/= 100,000;
8) Continued from # 7: (4) biologic, immunotherapy or cytostatic agents within 4 weeks prior to study entry;(5) radiation therapy within 2 weeks prior to entry on this study; (6) any medication known to cause QT interval prolongation.
9) Patients who have had any surgery other than resection of a brain tumor within 2 weeks prior to entry on this study.
10) Patient unwilling to or unable to comply with the protocol.
11) Patients who have a contraindication to MRI imaging (cardiac pacemaker, other ferromagnetic metal implants, claustrophobia not amenable to conscious sedation, and obesity greater than 300 lbs). |