An Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma
ConditionNeuroblastoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age1-18
SponsorPrincess Maxima Center for Pediatric Oncology
About this trial
This is a non-randomized, open label phase Ib/II dose-escalation and expansion study designed to define the recommended dose of anti-GD2-800CW in pediatric neuroblastoma patients. The aim of this imaging study is to determine a safe and effective dose of anti-GD2-800CW for intra-operative detection of neuroblastoma using NIR fluorescence.
Eligibility criteria
Qualifiers
Patients with the diagnosis of neuroblastoma as defined by histopathology (confirmed by the PMC Department of Pathology), who will be operated for NB as standard of care procedure
Patients older than 1 year of age and not older than 18 years.
Written informed consent from patients and/or from parents or legal guardians, according to local law and regulations
Disqualifiers
Previous treatment with Dinutuximab-beta, either alone or in combination with chemotherapy
Pregnancy or positive pregnancy test (urine or serum) in females of childbearing potential. Pregnancy test must be performed within during the screening period and before the administration of the IMP.
Breast feeding.
Sexually active participants not willing to use highly effective contraceptive method (pearl index <1) as defined in CTFG HMA 2020 (Appendix I) during trial participation and until 6 months after end of protocol therapy.
Trial design
Treatments tested in this trial
- anti-GD2-800CW
Treatment groups
22 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov