NCT01756989

Brief Summary

The purpose of this study is to determine whether initial local irradiation with topotecan and following oral antiangiogenic drugs, thalidomide, celecoxib and etoposide are effective in the treatment of pediatric diffuse brainstem tumor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2005

Longer than P75 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

Study Start

First participant enrolled

January 1, 2005

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2011

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

December 28, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 8, 2014

Status Verified

May 1, 2014

Enrollment Period

8.9 years

First QC Date

May 18, 2011

Last Update Submit

May 7, 2014

Conditions

Brainstem Glioma

Outcome Measures

Primary Outcomes (1)

  • Survival

    Primary outcome measure is survival in months.

    up to five years

Study Arms (1)

Thalidomide, etoposide, celecoxib

EXPERIMENTAL

Single arm study,phase II

Drug: Thalidomide, etoposide, celecoxib

Interventions

Thalidomide, etoposide, celecoxibDRUG

Thalidomide p.o. 1 mg/kg/day/1; the dose is gradually escalated, the maximum dose being 6 mg/kg/day. (The individual dose is set based on adverse effects.) Celecoxib p.o. 230 mg/m2/day/1-2, or in small children at 7 mg/kg/day in 1-2 doses. Etoposide p.o. the initial dosage 20 mg/m2/day; the dose is gradually escalated, the maxi 70 mg/m2/day.

Also known as: vepesid (etoposide), celebra (celecoxib)
Thalidomide, etoposide, celecoxib

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • pediatric diffuse brainstem tumor

You may not qualify if:

  • wish of the family
  • need for strong painrelievers
  • decreased level of consciousness
  • inability to swallow.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Div of Hem/Onc and SCT, Children's Hospital, HUCH

Helsinki, 00029, Finland

Location

MeSH Terms

Interventions

ThalidomideEtoposideCelecoxib

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesBenzenesulfonamidesSulfonamidesAmidesBenzene DerivativesSulfonesSulfur CompoundsPyrazolesAzoles

Study Officials

  • Sanna-Maria Kivivuori, md

    Helsinki University Central Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sanna-Maria Kivivuori/Consultant in Pediatric Hematology and Oncology

Study Record Dates

First Submitted

May 18, 2011

First Posted

December 28, 2012

Study Start

January 1, 2005

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 8, 2014

Record last verified: 2014-05

Locations

FI(1)