Badanie fazy III leku vincristine i aldesleukin: Neuroblastoma

Gdzie prowadzone jest badanie

Ośrodki prowadzące badanie w Polsce (10), alfabetycznie według miejscowości:

• Uniwersytecki Szpital Kliniczny W Bialymstoku Rekrutuje
  BiałystokKontakt
• Medical University of Bydgoszcz Rekrutuje
  BydgoszczKontakt
• Childrens' Hospital in Chorzów Rekrutuje
  ChorzówKontakt
• Medical University in Gdansk Rekrutuje
  GdańskKontakt
• Upper Silesian Centre of Child and Mother's Care Rekrutuje
  KatowiceKontakt
• University Children's Hospital Rekrutuje
  KrakówKontakt
• Children's University Hospital in Lublin Rekrutuje
  LublinKontakt
• University of Medical Sciences Rekrutuje
  PoznańKontakt
• Institute Mother and Child Rekrutuje
  WarszawaKontakt
• Wroclaw Medical University Rekrutuje
  WrocławKontakt

Więcej badań w tych miastach:

• Białystok
• Bydgoszcz
• Chorzów
• Gdańsk
• Katowice
• Kraków
• Lublin
• Poznań
• Warszawa
• Wrocław

Stan rekrutacji pochodzi z rejestrów badań i może się zmienić szybciej, niż zaktualizuje go sponsor. Nasz doradca sprawdzi aktualny stan w wybranym ośrodku. Nie publikujemy nazwisk lekarzy ani ich danych kontaktowych.

Cel badania

Opis z rejestru (w języku angielskim):

This is a randomized study of the European SIOP Neuroblastoma Group (SIOPEN) in high-risk neuroblastoma (stages 2, 3, 4 and 4s MYCN-amplified neuroblastoma, stage 4 MYCN non amplified \> 12 months at diagnosis).

The protocol consists of a rapid, dose intensive induction chemotherapy, peripheral blood stem cell harvest, attempted complete excision of the primary tumour, myeloablative therapy followed by peripheral blood stem cell rescue, radiotherapy to the site of the primary tumour and immunotherapy (R4 randomization - isotretinoin and ch14.18/CHO (Dinutuximab beta, Qarziba ®).), with or without s.c. aldesleukin (IL-2)). Patients diagnosed after the closure of R3 randomization will not be R4 randomized. For these patients the use of ch14.18/CHO antibody is recommended without scIL-2 as continuous infusion as standard of care outside of controlled trials. ch14.18/CHO received marketing authorization by EMA in May 2017 (Qarziba ®).

In the induction phase, all patients receive Rapid COJEC following the result of the R3 randomization which was closed on June 8th, 2017 after inclusion of 630 patients as planned.

Following induction treatment peripheral blood stem cell harvest (PBSCH) is performed and complete excision of the primary tumour will be attempted.

Patients with an inadequate metastatic response to allow BuMel MAT followed by PBSCR at the end of induction should receive 2 TVD (Topotecan, Vincristine, Doxorubicin) cycles.

After Rapid COJEC induction, localized patients will proceed to consolidation. Patients aged 12-18 months at diagnosis, with stage 4 neuroblastoma, no MYCN amplification and without segmental chromosomal alterations (SCAs) are thought to have a good prognosis and will stop treatment after induction therapy and surgery to the primary tumour.

Consolidation consists of BuMel MAT based on the results of the R1 randomization followed by peripheral blood stem cell rescue (PBSCR) and radiotherapy to the site of the primary tumour.

The R2 immunotherapy randomization using ch14.18/CHO as 8 hour infusion on 5 consecutive days ( total dose (100mg/m²) with or without aldesleukin (IL-2) alternated with isotretinoin (13-cis-RA) is closed.

Leczenie w badaniu

Kryteria udziału

Kryteria w języku angielskim, tak jak w rejestrze.

To główne kryteria z rejestru. Pełną listę i ostateczną decyzję o udziale ustala lekarz prowadzący badanie.