NCT00561873

Completed

Nimotuzumab in Children With HGG

Oncoscience AG Source

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Other study identifiers

Sponsor study identifier

BN001-PED04

Study Type

observational

Actual enrollment (reported)

45

Locations

1 country

Sites

1

Timeline

Study Start

June 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

February 2007

Actual (reported)

Brief Summary

Determination of efficiency of nimotuzumab in children with high grade glioma.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 45 participants
Study completion date: February 2007
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 2004
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
February 2007
Actual (reported)
First Submitted
November 20, 2007
Actual (reported)
First Posted
November 21, 2007
Actual (reported)

Last Updated: November 21, 2007
Status Verified: November 2007
Last Update Submitted: November 20, 2007

Conditions

High Grade Glioma

Keywords

astrocytoma, glioblastoma, intrinsic pontine glioma

Outcome Measures

Primary Outcomes (1)

Response rate according to RECIST criteria
week 8, week 21

Secondary Outcomes (1)

Progress free interval, Toxicity according to CTC criteria, Symptom control
week 8, week 21

Eligibility Criteria

Age3 Years - 20 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

Sampling MethodNon-Probability Sample

Study Population

children, adolescents

You may qualify if:

Histologically confirmed diagnosis of high grade glioma (WHO III und IV) \[not needed for intrinsic pontine glioma\]

Sponsors & Collaborators

Children's Medical Hospital, Medical School Hannover, Hannover, Germany
Type not reportedcollaborator
Dept. of Statistics, University of Dortmund, Germany
Othercollaborator

Study Sites (1)

University Bonn, Children's Medical Hospital

Bonn, 53113, Germany

MeSH Terms

Conditions

GliomaAstrocytomaGlioblastoma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

Udo Bode, Prof. MD
University of Bonn
PRINCIPAL INVESTIGATOR

Enrollment

45 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

November 20, 2007

First Posted

November 21, 2007

Study Start

June 2004

Date type not reported

This date has not been verified as actual or estimated.

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Phase 2Completed

NCT04737577

Glioma Supra Marginal Incision Trial

Not ApplicableCompleted

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STARLITE for Unresectable High-Grade Gliomas

Phase 1Recruiting

NCT00003535

Antineoplaston Therapy in Treating Children With Recurrent or Refractory High-Grade Glioma

Phase 2Terminated

NCT01499823

Permeability Map to Distinguish Progression From Pseudoprogression in High-Grade Glioma

Unknown

NCT05644080

68Ga/177Lu-PSMA Theranostics in Recurrent Grade 3 and Grade 4 Glioma

Not ApplicableCompleted

Progressive patients under primary therapy or first and second radiologically confirmed recurrence(MRI not older than 2 weeks) of high grade gliomas between the age of \> 3 years \< 20 years

Lack of curative standard therapy which is currently under investigation in a national GPOH-therapy optimization study

Sufficient haematological, renal and hepatic function (CTC Grad ≤ 2)

Disease measurable radiologicaly in at least one dimension

Life expectancy \> 4 Weeks

Written declaration of consent of the parents/legal guardians and if possible of the child after prior information

You may not qualify if:

Curative therapy with an alternative method after diagnosis of progression and during this study
Prior administration of human or murine antibody
Pregnancy in girls of child-bearing age

Contact the study team to confirm eligibility.

Children's Medical Hospital, University of Essen, Essen, Germany

Othercollaborator

Dept. of Neuropediatrics and Muscle Disorders, University of Freiburg, Germany

Othercollaborator

Oncoscience AG

Industrylead

Children's Medical Hospital, University of Homburg/Saar, Homburg/Saar, Germany

Othercollaborator

University of Regensburg

Othercollaborator

University Hospital Augsburg

Othercollaborator

CRM Biometrics GmbH

Industrycollaborator

Children's Medical Hospital, University of Bonn, Germany

Othercollaborator

University of Wuerzburg

Othercollaborator

Universitätsklinikum Hamburg-Eppendorf

Othercollaborator

Heinrich-Heine University, Duesseldorf

Othercollaborator

University of Cologne

Othercollaborator

Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany

Othercollaborator

University of Bonn

Othercollaborator

Study Completion

February 2007

Actual (reported)

Last Updated

November 21, 2007

Record last verified: 2007-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00561873
Data provider: ClinicalTrials.gov
Source updated: 2007-11-21
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:46 UTC

Locations

DE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations