Dosing Study of Ara-C/EL625/Idarubicin in Refractory and Relapsed AML

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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 combination with Cytarabine (Ara-C).

Cenersen sodium is a drug that is designed to block the effects of a protein called p53. Laboratory evidence shows that blocking p53 will make many types of cancer, including acute myelogenous leukemia (AML), more sensitive to a variety of established cancer therapeutics while making normal tissues more resistant to the toxic effects of these agents.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eleos, Inc.
• Treatments: Cytarabine; Idarubicin

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)