NCT00561691

Completed

Nimotuzumab in Children With Intrinsic Pontine Glioma

Oncoscience AG Source

Compare

Other study identifiers

Sponsor study identifier

OSAG101-BSC05

Study Type

observational

Actual enrollment (reported)

41

Locations

1 country

Sites

1

Timeline

Study Start

April 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

January 2012

Actual (reported)

Brief Summary

Determination of efficiency of nimotuzumab in children with diffuse intrinsic pontine 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): 41 participants
Study completion date: January 2012
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

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

Study Start
April 2006
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
November 20, 2007
Actual (reported)
First Posted
November 21, 2007
Actual (reported)
Study Completion
January 2012
Actual (reported)

Last Updated: March 29, 2013
Status Verified: March 2013
Last Update Submitted: March 27, 2013

Conditions

Diffuse Instrinsic Ponitine Glioma

Keywords

diffuse instrinsic ponitine glioma, brainstem

Outcome Measures

Primary Outcomes (1)

To determine the progression-free survival (PFS) of the combination of monoclonal anti-EGFR antibody OSAG 101 and standard local radiotherapy
week 12, 24, 36

Secondary Outcomes (1)

To determine the objective response rate (R=CR+PR+SD/Nr) according to RECIST To determine the duration of response and the overall survival To assess adverse events and the toxicity profile according to CTCAE version 3.0
week 12, 24, 36

Interventions

nimotuzumabDrug

monoclonal antibody

Also known as: Theraloc

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age3 Years - 20 Years

Sexall

Healthy VolunteersNo

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

Sampling MethodNon-Probability Sample

Study Population

children and adolescents

You may qualify if:

Histology and staging of disease:

Sponsors & Collaborators

Children's Medical Hospital, Medical School Hannover, Hannover, Germany
Type not reportedcollaborator
Istituto Nazinonale Tumori, Div. of Paediatric Oncology,Milano, Italy
Type not reportedcollaborator

Study Sites (1)

University Bonn, Children's Medical Hospital

Bonn, 53113, Germany

MeSH Terms

Interventions

nimotuzumab

Study Officials

Udo Bode, Prof. MD
University of Bonn
PRINCIPAL INVESTIGATOR

Enrollment

41 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

November 20, 2007

First Posted

November 21, 2007

Study Start

April 2006

Date type not reported

This date has not been verified as actual or estimated.

NCT02011594

Phase II Study of Maintenance Treatment of Nimotuzumab for Advanced Esophageal Carcinoma

Phase 2Withdrawn

NCT01180166

Combination of Nimotuzumab,Capecitabine and Radiotherapy for Inoperable or Recurrent Gastric Cancer

Phase 2Unknown

NCT02293356

Phase IV Clinical Trial of Nimotuzumab in the Treatment of Nasopharyngeal Carcinoma

Phase 4Unknown

NCT02672241

Nimotuzumab in Combination With Radio-chemotherapy for the Treatment of Brainstem Tumor in Children

Phase 2Unknown

NCT03666221

Nimotuzumab for Recurrent Nasopharyngeal Carcinoma

Phase 2Unknown

NCT00957086

Study of Post-Op Adjuvant Concurrent Chemo-RT With or Without Nimotuzumab for Head & Neck Cancer

Phase 3Unknown

Newly diagnosed intrinsic pontine glioma documented by MRI and measurable in at least one dimension

Histology is not required for this study, tumour biopsy is not recommended General conditions

Age ≥ 3 years to ≤ 20 years, both gender

Life expectancy ≥ 4 weeks

Performance status ECOG ≥ 3 or Karnofsky/Lansky status ≥ 40%

Adequate haematological, renal, and hepatic function Absolute leukocyte count ≥ 2.0 x 109/l Haemoglobin ≥ 10 g/dl Platelets ≥ 50 x 109/l Bilirubin total ≤ 2.5 x ULN ALT/AST ≤ 5.0 x ULN Creatinine i. S. ≤ 1.5 x ULN

Prior/initial examinations (within 14 days prior to the start of therapy):

Cranial MRI (estimation of index lesion)

Clinical internal and neurological examination; body weight, height, surface, Performance status by ECOG, Karnofsky or Lansky

Blood cell count, blood gas analysis; serum analysis for electrolytes (Na, K, Ca, Mg), chloride, phosphate, creatinine, BUN, AST, ALT, bilirubin, GGT, LDH, lipase, total protein, CRP, blood sugar; coagulation test (Quick, PTT, TT); urinalysis

EKG, echocardiography in case of positive cardiac history

Pregnancy test in females of childbearing age Other criteria

Planned day of first antibody application within 14 days after MRI

Written and signed informed consent from patient and/or parents or legal guardian(s)(s) after being informed

+3 more criteria

You may not qualify if:

Pontine glioma as secondary malignancy
Low grade brain stem glioma (i.e. focal, cervicomedullar, tectal brain stem glioma)
Other severe underlying disease or pre-existing serious conditions which bear the risk of an inadequate study treatment (e.g. severe mental retardation, severe statomotoric retardation, severe cerebral palsy, congenital syndromes)
Prior antineoplastic therapy, inclusively chemotherapy, immunotherapy, radiotherapy
Prior administration of a recombinant human or mural antibody or known hypersensitivity to antibodies
Simultaneous antineoplastic therapy other than the study treatment
Participation in another therapeutic study or experimental treatment involving the underlying cancer disease
Pregnancy, lactating mother and inadequate contraception in females and males of childbearing age

Contact the study team to confirm eligibility.

Dept. of Statistics, University of Dortmund, Germany

Othercollaborator

Oncoscience AG

Industrylead

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

Othercollaborator

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

Othercollaborator

CRM Biometrics GmbH

Industrycollaborator

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

Othercollaborator

Children's Medical Hospital, University of Bonn, Germany

Othercollaborator

University of Wuerzburg

Othercollaborator

Burdenko Neurosurgery Institute

Othercollaborator

Heinrich-Heine University, Duesseldorf

Othercollaborator

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

Othercollaborator

Study Completion

January 2012

Actual (reported)

Last Updated

March 29, 2013

Record last verified: 2013-03

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: NCT00561691
Data provider: ClinicalTrials.gov
Source updated: 2013-03-29
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:35 UTC

Locations

DE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations