Dosing Study of Ara-C/EL625/Idarubicin in Refractory and Relapsed AML
Acute Myelogenous Leukemia
About this trial
This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring Refractory or Relapsed Acute Myelogenous Leukemia (AML), Antisense
Eligibility Criteria
Inclusion Criteria Subjects with either refractory AML (not achieving a CR after a single course of induction), or relapsed AML that have a CR for less than one year. greater or equal to 18 years old. Life expectancy of more than 4 weeks following initiation of treatment. Performance status (Zubrod) less or equal to 3. Total Bilirubin less or equal to 1.5 x upper normal limit (UNL) unless attributable to organ infiltration by leukemia, and ALT(SGPT) less or equal to 2.5 x UNL. Creatinine less or equal to 1.5 x UNL unless attributable to organ infiltration by leukemia. If plasma creatinine value is borderline, creatinine clearance greater or equal to 60 ml/min (actual or calculated), serum magnesium should be within the normal value. Subjects with liver and/or renal dysfunction due to organ infiltration by leukemia are eligible. Left Ventricular Ejection Volume (LVEF) of >50% as determined by multi-gated acquisition scan (MUGA) or echocardiogram. Able to comply with scheduled follow-up and with management of toxicity. Sexually active patients must use an effective method of contraception during the study dosing period. The following are considered acceptable methods of contraception: (i) oral contraceptive pill, (ii) condom, (iii) diaphragm plus spermicide, (iv) patient or partner surgically sterile, (v) patient or partner more than 2 years post-menopausal or (vi) injectable or implantable agent/device. Informed consent form obtained, signed and dated prior to initiation of treatment Exclusion Criteria: Subjects with M3 AML. Subjects receiving other anti-leukemia investigational agents (i.e., unapproved drugs). However, individual cases will be considered on a case-by-case basis for other investigational agents (e.g., antibiotics, antifungals). Pregnant or lactating subjects. Chemotherapy (including hydroxyurea) within three (3) weeks prior to initiation of therapy, unless there is evidence of rapidly progressive disease; then subjects may be enrolled with a minimum of two (2) weeks from previous treatments. Prohibited Medications during the first week of each course: Acetaminophen Hi-Dose antioxidants (e.g., Vitamins C, E; Multivitamins)
Sites / Locations
- University of California, San Diego
- University of Miami Health Center
- Washington University Medical Center (Siteman Cancer Center)
- Roswell Park Cancer Institute
- North Shore University Hospital
- M. D. Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
cenersen, idarubicin
cenersen, idarubicin, cytarabine
cenersen, idarubicin, HDAC
cenersen, idarubicin, no cytarabine
cenersen, idarubicin, standard dose cytarabine
cenersen, idarubicin, HDAC (high dose cytarabine)