NCT00021216

Brief Summary

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Phase I trial to study the effectiveness of bortezomib in treating children who have advanced solid tumors that have not responded to previous treatment.

Trial Health

87
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

Timeline
Completed

Started Nov 2001

Longer than 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

First Submitted

Initial submission to the registry

July 11, 2001

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2001

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

April 15, 2015

Status Verified

December 1, 2013

Enrollment Period

4.1 years

First QC Date

July 11, 2001

Last Update Submit

April 14, 2015

Conditions

Unspecified Childhood Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (3)

  • MTD defined as the dose at which fewer than 20% of patients experience DLT assessed using CTC version 2.0

    3 weeks

  • 20S proteasome inhibition

    The 95% confidence interval for the percent of patients who exhibit inhibition at a recommended dose level determined according to the table above is 61%-100%, if six patients are evaluated or 55%-100% if five patients are evaluated.

    Up to 2 weeks

  • Progression free survival

    Up to 24 months

Study Arms (1)

Treatment (bortezomib)

EXPERIMENTAL

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

Drug: bortezomibOther: laboratory biomarker analysisOther: pharmacological study

Interventions

bortezomibDRUG

Given IV

Also known as: LDP 341, MLN341, VELCADE
Treatment (bortezomib)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (bortezomib)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (bortezomib)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy exists
  • Histologic confirmation not required for brainstem glioma or optic pathway tumor
  • Ineligible for therapies of higher priority
  • Stratum II only:
  • No bone marrow involvement
  • Performance status - Karnofsky 50-100% (over 10 years of age)
  • Performance status - Lansky 50-100% (10 years of age and under)
  • At least 8 weeks
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 75,000/mm\^3 (transfusion independent)
  • Hemoglobin at least 8 g/dL (RBC transfusions allowed)
  • Bilirubin less than 1.5 mg/dL
  • ALT less than 5 times normal for age
  • Albumin at least 2 g/dL
  • Creatinine no greater than upper limit of normal for age
  • +26 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

Interventions

Bortezomib

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Susan Blaney

    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

July 11, 2001

First Posted

January 27, 2003

Study Start

November 1, 2001

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

April 15, 2015

Record last verified: 2013-12

Locations

US(1)