CONNECT2007
Research type
Research Study
Full title
Phase I/II Study of Lutathera in Patients with Recurrent and/or Progressive High-Grade Central Nervous System (CNS) Tumors and Meningiomas that Demonstrate Uptake on DOTATATE PET (CONNECT2007)
IRAS ID
1010108
Contact name
Margot Lazow
Contact email
Sponsor organisation
The Research Institute at Nationwide Children’s Hospital
Clinicaltrials.gov Identifier
Research summary
High-grade brain tumours remain a leading cause of death in children and adolescents. Despite significant advances in treatments the prognosis for patients with recurrent or progressive disease remains poor. There is therefore a critical need to develop new effective, well-tolerated therapies for children and adults with brain tumours.
This is a multicentre Phase I and Phase II study of Lutathera, a somatostatin peptide receptor radionuclide therapy, in paediatric and adult patients with recurrent and/or progressive high-grade central nervous system (CNS) tumours and meningiomas which express somatostatin type 2A receptors (SST2A) and demonstrate uptake on DOTATATE PET imaging.
Somatostatin receptors regulate cell growth and therefore represent a potential therapeutic target. Lutathera (Lutetium [Lu] 177 Dotatate), a radionuclide therapy which binds SST2A receptors and delivers local radiation has recently gained FDA approval for treatment of gastroenteropancreatic neuroendocrine tumours given its efficacy and safety in adult patients with these SST2A-expressing tumors.
This study investigates the safety and efficacy of Lutathera treatment in paediatric and adult patients whose tumors express SST2A and demonstrate uptake on DOTATATE PET. In both Phase I and II cohorts, Lutathera will be administered as an intravenous infusion on day 1 of each 8-week cycle for up to 4 cycles.
Participants will be recruited in the USA, Netherland and the UK. The trial is being conducted through the COllaborative Network for NEuro-oncology Clinical Trials (CONNECT), a multi-institutional paediatric neuro-oncology research consortium, comprised of 18 leading paediatric neuro-oncology centres, which is headquartered at Nationwide Children’s Hospital, USA.
CONNECT2007 will recruit 59 patients with 9 patients from the UK recruited over 36 months. The study is funded by CRUK. The sponsor is Nationwide Children’s Hospital, USA. Novartis will be providing Lutathera free of charge.REC name
London - Fulham Research Ethics Committee
REC reference
26/LO/0073
Date of REC Opinion
27 Feb 2026
REC opinion
Further Information Favourable Opinion