NCT00070551

Brief Summary

This phase I trial is studying the side effects and best dose of GTI-2040 and high-dose cytarabine in treating patients with refractory or relapsed acute myeloid leukemia. GTI-2040 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy, such as cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Giving GTI-2040 together with cytarabine may kill more cancer cells.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2003

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

5.4 years

First QC Date

October 3, 2003

Last Update Submit

June 3, 2013

Conditions

Adult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Recurrent Adult Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Maximum-tolerated dose (MTD) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

    Up to day 42

Secondary Outcomes (2)

  • Therapeutic response

    Up to 6 years

  • Change in R2 expression in circulating and marrow leukemia cells

    From baseline to up to 6 years

Study Arms (2)

Stratum I (GTI-2040, cytarabine)

EXPERIMENTAL

Patients receive GTI-2040 IV continuously on days 1-6 and high-dose cytarabine IV over 2 hours twice daily on days 2, 4, and 6.

Biological: GTI-2040Drug: cytarabineOther: pharmacological studyOther: laboratory biomarker analysis

Stratum II (GTI-2040, cytarabine)

EXPERIMENTAL

Patients receive GTI-2040 IV continuously on days 1-6 and high-dose cytarabine IV over 4 hours once daily on days 2-6. In both strata, treatment continues in the absence of unacceptable toxicity.

Biological: GTI-2040Drug: cytarabineOther: pharmacological studyOther: laboratory biomarker analysis

Interventions

GTI-2040BIOLOGICAL

Given IV

Stratum I (GTI-2040, cytarabine)Stratum II (GTI-2040, cytarabine)
cytarabineDRUG

Given IV

Also known as: ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U, cytosine arabinoside
Stratum I (GTI-2040, cytarabine)Stratum II (GTI-2040, cytarabine)
pharmacological studyOTHER

Optional correlative studies

Also known as: pharmacological studies
Stratum I (GTI-2040, cytarabine)Stratum II (GTI-2040, cytarabine)
laboratory biomarker analysisOTHER

Optional correlative studies

Stratum I (GTI-2040, cytarabine)Stratum II (GTI-2040, cytarabine)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed acute myeloid leukemia according to the WHO classification
  • Relapsed or refractory disease, meeting 1 of the following criteria:
  • Unresponsive to initial treatment
  • Recurrent disease after treatment with prior conventional or high-dose chemotherapy with or without stem cell support
  • CNS involvement allowed provided there are no residual leukemic cells detected in the cerebrospinal fluid after intrathecal or radiation chemotherapy
  • Performance status - ECOG 0-2
  • At least 4 weeks
  • Bilirubin no greater than 2 times upper limit of normal\* (ULN) (unless due to Gilbert's syndrome)
  • AST and ALT no greater than 3 times ULN\*
  • Creatinine no greater than 1.5 mg/dL\*
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Resting ejection fraction at least 50%\*
  • Not pregnant or nursing
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Congenital AbnormalitiesLeukemia, Myeloid, Acute

Interventions

GTI2040Cytarabine

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Guido Marcucci

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2003

First Posted

October 7, 2003

Study Start

September 1, 2003

Primary Completion

February 1, 2009

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

US(1)