NCT00042796

Brief Summary

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. This phase I trial is studying the side effects and best dose of decitabine in treating children with relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

August 5, 2002

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2002

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

2.8 years

First QC Date

August 5, 2002

Last Update Submit

January 22, 2013

Conditions

Childhood Acute Myeloblastic Leukemia With Maturation (M2)Childhood Acute Promyelocytic Leukemia (M3)Recurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Acute Myeloid LeukemiaSecondary Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • MTD defined as the highest dose at which fewer than one-third of patients experience DLT assessed using CTC version 2.0

    4 weeks

Secondary Outcomes (6)

  • CR rate

    Up to 3 years

  • PR rate

    Up to 3 years

  • DNA methylation

    Up to 3 years

  • Gene expression profiles

    Up to 3 years

  • HDAC/HAT activity

    Up to 3 years

  • +1 more secondary outcomes

Study Arms (1)

Treatment (decitabine)

EXPERIMENTAL

Patients receive decitabine IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 4-6 weeks for a minimum of 4 courses in the absence of disease progression or unacceptable toxicity.

Drug: decitabineOther: pharmacological studyOther: laboratory biomarker analysis

Interventions

decitabineDRUG

Given IV

Also known as: 5-aza-dCyd, 5AZA, DAC
Treatment (decitabine)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (decitabine)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (decitabine)

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Histologically confirmed acute myeloid leukemia (AML) or acute lymphoblastic leukemia that is considered refractory to conventional therapy or for which no conventional therapy exists
  • For patients with AML:
  • M3 marrow
  • M2 marrow with at least 15% blasts
  • Secondary AML allowed
  • CNS involvement allowed
  • Performance status - Karnofsky 50-100% (age 17 to 21)
  • Performance status - Lansky 50-100% (age 16 and under)
  • At least 8 weeks
  • See Chemotherapy
  • WBC no greater than 30,000/mm\^3
  • Patients with granulocytopenia, anemia, and/or thrombocytopenia are eligible but are not evaluable for hematological toxicity
  • Bilirubin no greater than 1.5 times normal
  • ALT no greater than 5 times normal
  • Albumin at least 2 g/dL
  • +33 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

AzacitidineAza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Norman Lacayo

    Children's Oncology Group

    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

August 5, 2002

First Posted

January 27, 2003

Study Start

December 1, 2002

Primary Completion

October 1, 2005

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

US(1)