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).

Sponsor
Fundación de investigación HM
Study ID
NCT06607692
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Adrenal Tumours
  • Carcinoma Adrenal
  • DIPG
  • Ependymoma
  • Ependymoma Recurrent
  • Esthesioneuroblastoma
  • Glioblastoma
  • Glioblastoma (GBM)
  • High Grade Gliomas
  • High Risk Neuroblastoma
  • Medulloblastoma
  • Medulloblastoma Recurrent
  • Meningioma
  • Neuroblastoma Recurrent
  • Neuroendocrine Tumours (NET)
  • Osteosarcoma Recurrent
  • Paraganglioma
  • Paraganglioma/ Phaeochromocytoma
  • Pheochromocytoma
  • Solid Tumor Cancer
  • Solid Tumor Refractory to Conventional Treatment
  • Synovial Sarcomas

Eligibility Criteria

Sex
ALL
Age
3 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib; 177Lu-DOTATATE — DRUG
    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).

Study Details

Study in children and adolescents of 177Lu DOTATATE (Lutathera®) combined with the PARP inhibitor olaparib for treatment of recurrent or relapsed solid tumours expressing somatostatin receptors (SSTR) (LuPARPed)

Key Dates

Start date
Sep 20, 2024
Status verified
Jun 2026
Primary completion
Jul 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lu-DOTATATE (Lutathera® ) and olaparib
    Lu-DOTATATE (Lutathera®) and olaparib for a maximum of 4 cycles unless unacceptable toxic effects occur, there is centrally confirmed disease progression (according to RECIST v1.1/RAPNO/INRC) on imaging, the patient is unable or unwilling to adhere to trial procedures, the patient withdraws consent, or the patient dies. 177Lu-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. Olaparib will be administered PO, BID, days 3-28, every 8 weeks. Dose escalation of olaparib with the classic 3+3 design: DL1 62.5 mg/m2 (max 100 mg); DL2 93.5 mg/m2 (max 150 mg); DL3 125 mg/m2 (max 200 mg).

Primary Outcome Measure

To estimate the safety of the combination of 177LUDOTATATE and olaparib. [ Time Frame: Through first cycle, an average of 8 weeks ]

Central Contacts

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