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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list