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

NCT00074737 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2014-09-18

No results posted yet for this study

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.

Conditions

  • Acute Myelogenous Leukemia

Interventions

DRUG

cenersen

cenersen with standard of care

DRUG

Idarubicin

standard of care for AML

DRUG

Cytarabine

standard of care Ara-C and High dose Ara-C

Sponsors & Collaborators

  • Eleos, Inc.

    lead INDUSTRY

Principal Investigators

  • Jorge E Cortes, MD · M.D. Anderson Cancer Center

  • Edward D. Ball, MD · University of California, San Diego

  • John DiPersio, MD · Washington University Medical Center, Siteman Cancer Center

  • Maria Baer · Roswell Park Cancer Institute

  • Jonathan Kolitz, MD, FACP · North Shore University Hospital

  • Hugo Fernandez, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2007-05-31
Completion
2007-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00074737 on ClinicalTrials.gov