NCT00074737

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2004

Typical duration for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2003

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2004

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

September 18, 2014

Status Verified

September 1, 2014

Enrollment Period

3.1 years

First QC Date

December 19, 2003

Last Update Submit

September 16, 2014

Conditions

Acute Myelogenous Leukemia

Keywords

Refractory or Relapsed Acute Myelogenous Leukemia (AML)Antisense

Outcome Measures

Primary Outcomes (1)

  • Determine the effective dose of Cytarabine chemotherapy to be used in combination with EL625 and Idarubicin.

    Cenersen plus standard of care

    6 months

Secondary Outcomes (2)

  • Determine the safety profile for the combination of EL625 and Idarubicin +/- Cytarabine.

    6 months

  • Determine the Complete Response Rate and Time to Progression.

    6 months

Study Arms (3)

cenersen, idarubicin

ACTIVE COMPARATOR

cenersen, idarubicin, no cytarabine

Drug: cenersenDrug: Idarubicin

cenersen, idarubicin, cytarabine

ACTIVE COMPARATOR

cenersen, idarubicin, standard dose cytarabine

Drug: cenersenDrug: IdarubicinDrug: Cytarabine

cenersen, idarubicin, HDAC

ACTIVE COMPARATOR

cenersen, idarubicin, HDAC (high dose cytarabine)

Drug: cenersenDrug: IdarubicinDrug: Cytarabine

Interventions

cenersenDRUG

cenersen with standard of care

Also known as: cenersen sodium, Ol(1)p53, EL625, Aezea
cenersen, idarubicincenersen, idarubicin, HDACcenersen, idarubicin, cytarabine
IdarubicinDRUG

standard of care for AML

Also known as: idamycin
cenersen, idarubicincenersen, idarubicin, HDACcenersen, idarubicin, cytarabine
CytarabineDRUG

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

Also known as: Ara-C, HDAC
cenersen, idarubicin, HDACcenersen, idarubicin, cytarabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of California, San Diego

La Jolla, California, 92093-0960, United States

Location

University of Miami Health Center

Miami, Florida, 33136, United States

Location

Washington University Medical Center (Siteman Cancer Center)

St Louis, Missouri, 63110, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

North Shore University Hospital

Lake Success, New York, 11041, United States

Location

M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

cenersenOL(1)p53IdarubicinCytarabine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Jorge E Cortes, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

  • Edward D. Ball, MD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

  • John DiPersio, MD

    Washington University Medical Center, Siteman Cancer Center

    PRINCIPAL INVESTIGATOR

  • Maria Baer

    Roswell Park Cancer Institute

    PRINCIPAL INVESTIGATOR

  • Jonathan Kolitz, MD, FACP

    North Shore University Hospital

    PRINCIPAL INVESTIGATOR

  • Hugo Fernandez, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2003

First Posted

December 23, 2003

Study Start

April 1, 2004

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

September 18, 2014

Record last verified: 2014-09

Locations

US(6)