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

ISRCTN	ISRCTN54672574
DOI	https://doi.org/10.1186/ISRCTN54672574
Protocol serial number	NAG9007
Sponsor	United Kingdom Children's Cancer Study Group (UK)
Funder	United Kingdom Children's Cancer Study Group (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Escherichia coli rHu and granulocyte-macrophage colony-stimulating factor (GM-CSF)
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/11/1993

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Year
Upper age limit	15 Years
Sex	All
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1993
Date of final enrolment	30/11/1993

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

21/01/2019: No publications found. All search options exhausted.
15/12/2015: no publications found on PubMed.