VERITAS - Trial Evaluating and Comparing Two Intensification Treatment Strategies for Metastatic Neuroblastoma Patients With a Poor Response to Induction Chemotherapy
Chief Investigator: Dr Dominique Valteau-Couanet
Sponsor: Institut Gustave Roussy, Paris
Funder/Charity: Institut National du Cancer
International Multicenter Phase II Randomised Trial Evaluating and Comparing Two Intensification Treatment Strategies for Metastatic Neuroblastoma Patients With a Poor Response to Induction Chemotherapy.
This study aims to improve the outcome for patients with high risk neuroblastoma which is refractory to induction chemotherapy
The trial is a prospective, open-label, randomised, multi-centre phase 2 trial. It aims to evaluate the efficacy of two intensified consolidation strategies:
high dose 131I-mIBG therapy with topotecan, followed by high dose Busulfan-Melphalan (Bu-Mel)
High dose thiotepa followed by high dose Bu-Mel
Each phase of the intensified treatment is supported by autologous stem cell rescue (ASCR).
The trial opened in October 2018 and is now closed. It has recruited 34 patients. A total of 78 sites participated, including France, Spain, The Netherlands, Italy, the UK, Austria, Germany and Israel.
No results are available from the study yet
Further details about the trial can be found at clinicaltrials.gov database: https://clinicaltrials.gov/ct2/show/NCT03165292