Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
15/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NAG9007

Study information

Scientific title

A randomised, parallel group study on efficacy and tolerability of Escherichia coli rHu granulocyte-macrophage colony-stimulating factor (GM-CSF) given subcutaneously for seven days after chemotherapy in paediatric malignancy

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chemotherapy in paediatric malignancy

Intervention

1. GM-CSF regimen: myelosuppressive chemotherapy followed by Escherichia coli rHu GM-CSF given subcutaneously for seven days
2. Control regimen: myelosuppressive chemotherapy

Intervention type

Drug

Phase

Not Applicable

Drug names

Escherichia coli rHu and granulocyte-macrophage colony-stimulating factor (GM-CSF)

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1993

Overall trial end date

30/11/1993

Reason abandoned

Eligibility

Participant inclusion criteria

1. Newly diagnosed soft tissue sarcoma, Ewing's sarcoma, medulloblastoma, osteosarcoma or Non-Hodgkin's Lymphoma
2. Age range 1 to 15 years
3. No history of anaphylaxis
4. No severe lung, heart or kidney impairment

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1993

Recruitment end date

30/11/1993

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

United Kingdom Children's Cancer Study Group (UK)

Sponsor details

University of Leicester
3rd floor
Hearts of Oak House
9 Princess Road West
Leicester
LE1 6HT
United Kingdom

Sponsor type

Research organisation

Website

http://www.ukccsg.org

Funders

Funder type

Research organisation

Funder name

United Kingdom Children's Cancer Study Group (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

15/12/2015: no publications found on PubMed.