Neuroblastoma
Conditions
Interventions
Trade Name: 131-I meta-iodobenzylguanidine
Product Name: 131-I meta-iodobenzylguanidine
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: 131-I meta-iodobenzylguanidine
C
Sponsors
University Hospitals of Leicester NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Is aged 1 year or over and has high-risk neuroblastoma (INSS Stage 4, or Stage 2 or 3 with MycN amplification) 2) Is enrolled on the SIOP-Europe high-risk neuroblastoma study or has been treated according to that protocol, or has been treated according to a similar protocol 3) Fails to achieve satisfactory remission with induction chemotherapy (defined as >50% reduction or more than 3 positive sites on mIBG scintigraphy, or persistent cytomorphological positive disease in bone marrow aspirates or trephine biopsies) at day 80 after COJEC induction, (or progressive disease at an earlier date necessitating a change to treatment) 4) has mIBG positive disease on diagnostic scintigraphy at the time of consideration of entry to this study 5) is being treated at, or clinicians and parents (or the patient in the case of an adult) are willing for the patient to be referred to, a centre participating in this study 6) has parents who are willing to consider entry into this study and who give informed consent in writing or, in the case of a competent adult, the patient may give informed consent on their own. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Not meeting any of the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate a novel combination of mIBG given at a higher dose than usual in conjunction with topotecan. There is good experimental evidence to indicate that this may yield better results. Primary resistant high risk neuroblastoma: Assess a salvage schedule of treatment for patients with high-risk neuroblastoma treated with rapid COJEC in the SIOP-Europe High-Risk Study whose disease has failed to respond sufficiently to proceed to surgery for the primary tumour. Relapsed stage 4 neuroblastoma: Assess a palliative schedule of treatment for patients with stage 4 neuroblastoma who have relapsed after intensive treatment including high dose chemotherapy with haemopoietic progenitor cell support. ;Secondary Objective: Secondly, this study aims to investigate, where possible, the radiation dose received by the cancer (as distinct from the activity of radiation administered to the patient), and also the value of PET scanning in addition to mIBG scanning in the assessment of disease extent and the response to treatment.;Primary end point(s): Primary resistant high risk neuroblastoma: 1. The proportion of patients who respond to treatment (PR and CR at metastatic sites), evaluated by mIBG scintigraphy in conjunction with, where possible, PET and CT imaging. 2. The proportion of patients who, as a result of this treatment, are able to progress to potentially curative treatment with surgery, and further systemic treatment. 3. To perform, where possible, tumour dosimetry to see whether the tumour absorbed radiation dose (as distinct from the whole body measurement) correlates with response in that tumour. Relapsed stage 4 neuroblastoma: 1. The proportion of patients who respond to treatment (PR and CR at metastatic sites), evaluated by mIBG scintigraphy in conjunction with, where possible, PET and CT imaging. 2. The time to tumour progression. 3. To perform, where possible, tumour dosimetry to see whether the tumour absorbed radiation dose (as distinct | — |
Countries
United Kingdom
Outcome results
None listed