NCT00030667

Brief Summary

Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have relapsed or refractory solid tumors of childhood. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2002

Typical duration for phase_2

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

February 14, 2002

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2002

Completed
1 year until next milestone

First Posted

Study publicly available on registry

May 7, 2003

Completed
2.6 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

3.6 years

First QC Date

February 14, 2002

Last Update Submit

April 14, 2015

Conditions

Childhood Desmoplastic Small Round Cell TumorChildhood Synovial SarcomaGastrointestinal Stromal TumorLung MetastasesRecurrent Childhood Soft Tissue SarcomaRecurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal TumorRecurrent NeuroblastomaRecurrent Osteosarcoma

Outcome Measures

Primary Outcomes (2)

  • Response rate, determined using the RECIST criteria

    95% confidence interval will be computed.

    Up to 2 years

  • Toxicity reported using the CTC version 2.0

    Up to 2 years

Secondary Outcomes (1)

  • Time to disease progression

    Up to 2 years

Study Arms (1)

Treatment (imatinib mesylate)

EXPERIMENTAL

Patients receive oral imatinib mesylate once or twice daily on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Drug: imatinib mesylateOther: laboratory biomarker analysisOther: pharmacological study

Interventions

imatinib mesylateDRUG

Given orally

Also known as: CGP 57148, Gleevec, Glivec
Treatment (imatinib mesylate)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (imatinib mesylate)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (imatinib mesylate)

Eligibility Criteria

AgeUp to 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Histologically confirmed solid tumors including the following:
  • Ewing's sarcoma
  • Bone or soft tissue primitive neuroectodermal tumor
  • Osteosarcoma
  • Neuroblastoma
  • Desmoplastic small round cell tumor
  • Synovial cell sarcoma
  • Gastrointestinal stromal tumor (GIST)
  • Metastatic pulmonary disease eligible
  • No pleural effusion of any size or definite radiologic evidence of pleural-based disease
  • Recurrent or refractory to conventional therapy
  • GIST eligible at initial presentation
  • Tumor tissue blocks must be available
  • At least 1 measurable lesion
  • At least 20 mm by conventional techniques
  • +35 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

Desmoplastic Small Round Cell TumorGastrointestinal Stromal TumorsNeuroectodermal Tumors, Primitive, PeripheralNeuroblastomaOsteosarcoma

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

SarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Connective TissueGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeoplasms, Bone Tissue

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Mason Bond

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2002

First Posted

May 7, 2003

Study Start

May 1, 2002

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

April 15, 2015

Record last verified: 2013-12

Locations

US(1)