Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined with the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).

PHASE2RecruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

October 31, 2024

Primary Completion Date

July 31, 2029

Study Completion Date

December 31, 2029

Conditions
Solid Tumor CancerMedulloblastomaHigh Risk NeuroblastomaHigh Grade GliomasMeningiomaParagangliomaPheochromocytomaNeuroendocrine Tumours (NET)Adrenal Tumours
Interventions
DRUG

Olaparib; 177Lu-DOTATATE

7Lu-DOTATATE will be administered intravenously, on day 1, every 8 weeks, at a fixed dose of 200 mCi (7.4 GBq) for children \>= 12 years old infused intravenously over a period of 30 minutes. For children younger than 12 years old, the dose that will be administered is 200 MBq per kilogram of body weight (maximum 7.4 GBq) infused intravenously over a period of 30 minutes. Concomitant to 177Lu-DOTATATE, patients will receive IV fluids and an IV infusion of amino acid solution for renal protection23. Patients will receive four infusions every 8 weeks (maximum cumulative radioactivity, 29.6 GBq \[800 mCi\]). Olaparib will be administered PO, BID, days 2-29, every 8 weeks at a fixed dose of 187.5mg/m2 twice daily (BID).

Trial Locations (1)

28660

RECRUITING

HM Monteprincipe, Boadilla del Monte

All Listed Sponsors
lead

Fundación de investigación HM

OTHER