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 |
| Secondary identifying numbers | NAG9007 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 21/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
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
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/1993 |
| Completion date | 30/11/1993 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
United Kingdom Children's Cancer Study Group (UK)
Research organisation
Research organisation
University of Leicester
3rd floor
Hearts of Oak House
9 Princess Road West
Leicester
LE1 6HT
United Kingdom
| Website | http://www.ukccsg.org |
|---|
Funders
Funder type
Research organisation
United Kingdom Children's Cancer Study Group (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
21/01/2019: No publications found. All search options exhausted.
15/12/2015: no publications found on PubMed.
