newly diagnosed, relapsed or refractory metastatic neuroblastoma MedDRA version: 20.0 Level: PT Classification code 10029260 Term: Neuroblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: [124I]mIBG Solution for Injection
Product Code: [124I]mIBG Solution for Injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: [124I]mIBG
Current Sponsor code: [124I]
Sponsors
Cancer Research UK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically proven neuroblastoma with stage 4 disease as defined by the International Neuroblastoma Staging System (INSS). 2. Aged = 1 year at the time that written informed consent is given. 3. Planned to undergo conventional [123I]mIBG planar scintigraphy for routine clinical care of neuroblastoma. 4. Life expectancy of at least 12 weeks. 5. World Health Organisation (WHO) performance status of 0, 1 or 2 for patients aged >12 years old or Lansky play scale score of =50% for patients aged = 12 years old. 6. Written (signed and dated) informed consent from patient = 16 years old and/or parent or legal guardian for patients 16 years old Laboratory Test Value required Haemoglobin (Hb) = 8.0 g/dl (N.B. transfusions will be allowed) Absolute neutrophil count (ANC) = 0.50 x 10^9/L (N.B. G-CSF support will be allowed) Platelet count = 50 x 10^9/L (N.B. transfusions will be allowed) Serum bilirubin
Exclusion criteria
Exclusion criteria: 1. Treatment with any medications contra-indicated with mIBG scanning as listed in protocol. For example, decongestants containing pseudoephedrine, phenylpropalomine and phenylephrine, sympathomimetics, cocaine, antihypertensives, tricyclic antidepressants. These drugs should be stopped before administration as indicated in this list (usually for four biological half-lives to allow almost complete wash-out but refer to list). The Investigator should seek prospective approval of any planned variation from this list from the responsible Nuclear Medicine Consultant, CI and sponsor Medical Advisor. 2. Stage 4S neuroblastoma as defined by the INSS. 3. Any anti-cancer treatment planned between the routine [123I]mIBG imaging and the [124I]mIBG PET/CT scan on Day 2. Anti-cancer treatments can be started only after the Off-Study assessment on Day 3 to Day 7, see schedule of assessments in protocol. N.B. Patients should not be enrolled in the study if their participation will delay their subsequent treatment for neuroblastoma. 4. Female patients who are pregnant or lactating. 5. At high medical risk because of non-malignant systemic disease including active uncontrolled infection. 6. Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV). 7. Patients with known hypersensitivity to mIBG. 8. Any other condition which in the Investigator’s opinion would not make the patient a good candidate for the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show that [124I]mIBG PET/CT can detect an equal or greater number of neuroblastoma lesions compared to conventional [123I]mIBG planar scintigraphy.;Secondary Objective: 1. To show that [124I]mIBG PET/CT can detect an equal or greater number of neuroblastoma lesions compared to conventional [123I]mIBG scintigraphy with 3D imaging by SPECT. 2. Assessing the safety and toxicity profile of a single intravenous administration of [124I]mIBG.;Primary end point(s): Comparison of the percentage of lesions detected as positive by [123I]mIBG planar scintigraphy which are also considered positive with [124I]mIBG PET/CT.;Timepoint(s) of evaluation of this end point: [124I]mIBG PET/CT scan to be performed 24 h (+3 h) after the administration of [124I]mIBG. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Comparison of the percentage of lesions detected as positive by [123I]mIBG SPECT which are also considered positive with [124I]mIBG PET/CT. 2. Determining the causality of each adverse event to [124I]mIBG and grading severity according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.02.;Timepoint(s) of evaluation of this end point: 1. [124I]mIBG PET/CT scan to be performed 24 h (+3 h) after the administration of [124I]mIBG. 2. SAE and AE collection and monitoring commences from the time the patient gives their written consent to participate in the trial and continues for 7 days after the administration of [124I]mIBG. Follow-up of AEs with a causality of possible, probable or highly probable will continue until resolution, recovery to baseline, or stabilisation of these events unless the patient starts another anti-cancer therapy. | — |
Countries
United Kingdom
Contacts
Public ContactCentre for Drug Development
Cancer Research UK
Outcome results
None listed