NCT00077467

Brief Summary

This phase I trial is studying the side effects and best dose of bortezomib in treating young patients with refractory or recurrent leukemia. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.

Trial Health

80
On Track

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
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

January 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

2.2 years

First QC Date

February 10, 2004

Last Update Submit

June 4, 2013

Conditions

Blastic Phase Chronic Myelogenous LeukemiaChildhood Acute Promyelocytic Leukemia (M3)Recurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (3)

  • Maximum tolerated dose and recommended phase II dose

    Up to 21 days

  • Toxicity as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) 3.0

    Up to 2 years

  • Pharmacokinetics as assessed by confidence intervals (CI), area under the curve (AUC), and half-life (T ½)

    Pretreatment, days 1, 8, 18-22 of course 1

Secondary Outcomes (2)

  • Antitumor activity

    Up to 2 years

  • Correlate apoptosis and NF-kB activation

    Prestudy, days 8 and 18

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: bortezomibOther: pharmacological studyOther: laboratory biomarker analysis

Interventions

bortezomibDRUG

Given IV

Also known as: LDP 341, MLN341, VELCADE
Arm I
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Arm I
laboratory biomarker analysisOTHER

Correlative studies

Arm I

Eligibility Criteria

Age1 Year - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Histologically confirmed leukemia of 1 of the following types:
  • Acute lymphoblastic leukemia
  • Acute myeloid leukemia
  • Chronic myelogenous leukemia in blast crisis
  • Relapsed or refractory disease
  • Immunophenotypically confirmed disease, either at initial diagnosis or relapse
  • More than 25% blasts in the bone marrow (M3 bone marrow)
  • Active extramedullary disease (except leptomeningeal disease) allowed
  • No known curative therapy or therapy proven to prolong survival with an acceptable quality of life available
  • Performance status - Karnofsky 50-100% (for patients age 11 to 21)
  • Performance status - Lansky 50-100% (for patients age 10 and under)
  • Platelet count ≥ 20,000/mm\^3\*
  • Hemoglobin ≥ 8.0 g/dL\*
  • WBC \< 20,000/mm\^3\*\* (hydroxyurea for cytoreduction allowed)
  • No hyperleukocytosis (i.e., WBC \> 100,000/mm\^3)
  • +35 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

COG Phase I Consortium

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Conditions

Blast CrisisPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Terzah Horton

    COG Phase I 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

February 10, 2004

First Posted

February 12, 2004

Study Start

January 1, 2004

Primary Completion

March 1, 2006

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

US(1)