NCT00049582

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 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

Study Start

First participant enrolled

September 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2002

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Last Updated

September 30, 2013

Status Verified

September 1, 2013

Enrollment Period

7.8 years

First QC Date

November 12, 2002

Last Update Submit

September 27, 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)Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negativede Novo Myelodysplastic SyndromesMyelodysplastic/Myeloproliferative Neoplasm, UnclassifiablePreviously Treated Myelodysplastic SyndromesRecurrent Adult Acute Myeloid LeukemiaSecondary Acute Myeloid LeukemiaSecondary Myelodysplastic SyndromesUntreated Adult Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose (MTD) of decitabine, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0

    Up to day 28

Secondary Outcomes (4)

  • Minimal effective dose of decitabine that will lead to demethylation of deoxyribonucleic acid (DNA) with tolerable toxicity as assessed by RXR gene

    Up to day 28

  • Proportion of patients with in-vitro retinoid response

    Up to 8 years

  • Duration of clinical response

    Up to 8 years

  • Changes in gene expression, gene methylation and bone marrow aspirate sample measurements

    Up to day 5

Study Arms (1)

Treatment (decitabine)

EXPERIMENTAL

Patients receive decitabine IV over 3 hours twice daily OR IV over 1 hour once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of decitabine until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Drug: decitabineOther: laboratory biomarker analysisOther: pharmacological study

Interventions

decitabineDRUG

Given IV

Also known as: 5-aza-dCyd, 5AZA, DAC
Treatment (decitabine)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (decitabine)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (decitabine)

Eligibility Criteria

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

You may qualify if:

  • One of the following diagnoses:
  • High-risk myelodysplastic syndromes (MDS)
  • Acute myeloid leukemia (AML)
  • De novo, secondary, or relapsed disease
  • Any number of prior regimens for primary or relapsed disease
  • Ineligible for or refuses aggressive management
  • Measurable disease, defined as:
  • More than 5% blasts in bone marrow of patients with MDS
  • More than 30% blasts in bone marrow of patients with AML
  • Involvement of cerebrospinal fluid allowed
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • See Disease Characteristics
  • Bilirubin no greater than 1.25 times upper limit of normal (ULN)
  • AST and/or ALT no greater than 1.25 times ULN
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Hospital Phase 2 Consortium

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Congenital AbnormalitiesLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMyeloproliferative DisordersLeukemia, Myeloid, Acute

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyelodysplastic-Myeloproliferative DiseasesBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Mark Minden

    Princess Margaret Hospital Phase 2 Consortium

    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

November 12, 2002

First Posted

January 27, 2003

Study Start

September 1, 2002

Primary Completion

June 1, 2010

Last Updated

September 30, 2013

Record last verified: 2013-09

Locations

CA(1)