Status:
COMPLETED
Dosing Study of Ara-C/EL625/Idarubicin in Refractory and Relapsed AML
Lead Sponsor:
Eleos, Inc.
Conditions:
Acute Myelogenous Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The principal goal of this clinical trial is to assess the ability of cenersen sodium (EL625) to improve cancer responsiveness to the established AML therapeutic agent Idarubicin used alone or in comb...
Detailed Description
This clinical trial is designed to assess the ability of cenersen sodium (EL625) in combination with Idarubicin alone or with Cytarabine to either: (1) induce remissions in patients who have previousl...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00074737
Start Date
April 1 2004
End Date
May 1 2007
Last Update
September 18 2014
Active Locations (6)
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1
University of California, San Diego
La Jolla, California, United States, 92093-0960
2
University of Miami Health Center
Miami, Florida, United States, 33136
3
Washington University Medical Center (Siteman Cancer Center)
St Louis, Missouri, United States, 63110
4
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263