NCT00077181

Brief Summary

Drugs used in chemotherapy, such as cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. 3-AP may help cytarabine kill more cancer cells by making them more sensitive to the drug. This phase I trial is studying the side effects and best dose of 3-AP when given with high-dose cytarabine in treating patients with advanced hematologic malignancies

Trial Health

80
On Track

Trial Health Score

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

Enrollment
48

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2004

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

4.5 years

First QC Date

February 10, 2004

Last Update Submit

January 23, 2013

Conditions

Accelerated Phase Chronic Myelogenous LeukemiaAdult 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)Blastic Phase Chronic Myelogenous LeukemiaRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Acute Myeloid LeukemiaRelapsing Chronic Myelogenous LeukemiaSecondary Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • MTD defined as the dose preceding that at which greater than or equal to 2 patients experience dose-limiting toxicity assessed using NCI CTCAE version 3.0

    28 days

Study Arms (1)

Treatment (cytarabine and triapine)

EXPERIMENTAL

Patients receive high-dose cytarabine IV over 2 hours on days 1-5 and triapine IV over 2 hours on days 2-5. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Drug: cytarabineDrug: triapineOther: laboratory biomarker analysis

Interventions

cytarabineDRUG

Given IV

Also known as: ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U, cytosine arabinoside
Treatment (cytarabine and triapine)
triapineDRUG

Given IV

Also known as: 3-AP, OCX-191
Treatment (cytarabine and triapine)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (cytarabine and triapine)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed diagnosis of 1 of the following hematologic malignancies:
  • Relapsed or refractory acute myeloid leukemia (AML)
  • Relapsed or refractory acute lymphoblastic leukemia
  • Secondary AML, including AML arising from antecedent hematologic diseases, such as myelodysplastic syndromes or myeloproliferative disorders OR therapy-related AML
  • Chronic myeloid leukemia in accelerated or blast phase
  • Refractory to standard therapy or no standard therapy exists
  • No known brain metastases
  • Performance status - CALGB 0-2
  • Performance status - Karnofsky 60-100%
  • No G6PD deficiency
  • Bilirubin \< 2.0 mg/dL (unless due to Gilbert's syndrome)
  • AST and ALT \< 2.5 times upper limit of normal (ULN)
  • Creatinine \< 1.5 times ULN
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Accelerated PhaseCongenital AbnormalitiesBlast CrisisPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, Acute

Interventions

Cytarabine3-aminopyridine-2-carboxaldehyde thiosemicarbazone

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Olatoyosi Odenike

    University of Chicago Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2004

First Posted

February 11, 2004

Study Start

January 1, 2004

Primary Completion

July 1, 2008

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

US(1)