TerminatedPhase 2

Evaluation of 2 Intensification Treatment Strategies for Neuroblastoma Patients With a Poor Response to Induction

Stopped: The Sponsor has been notified of an interruption in the international supply, and there is a possibility that 131I-mlBG would be unavailable to patients randomised to arm A of the trial

Austria, France, Italy34 participantsStarted 2018-10-01

Plain-language summary

The main objective is to evaluate the efficacy of two intensified consolidation strategies in very-high risk neuroblastoma (VHR-NBL) patients in terms of event-free survival from randomisation date. This evaluation will follow a hierarchical testing procedure: each experimental treatment will be first evaluated as a single-arm phase 2 study, and in case of positive conclusion, the relative efficacy of both arms will then be evaluated comparatively.

Who can participate

SexALL

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Inclusion criteria

✓. Metastatic neuroblastoma (NBL)
✓. Patient previously treated within the ongoing High Risk Neuroblastoma SIOPEN study or treated with the current standard treatment for very high risk neuroblastoma off-trial
✓. mIBG scintigraphy positive at diagnosis and after induction chemotherapy (pre BuMel evaluation).
✓. Metastatic response after induction chemotherapy lower than the ongoing High Risk Neuroblastoma SIOPEN trial criteria to be eligible for High Dose Chemotherapy (metastatic response worse than partial response (\< PR) or SIOPEN score \> 3)
✓. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of treatment. Sexually active patients must agree to use acceptable and appropriate contraception while on study drug and for one year after stopping the study drug. Acceptable contraception are defined in CTFG Guidelines "Recommendations related to contraception and pregnancy testing in clinical trials". Female patients who are lactating must agree to stop breast-feeding.
✓. Written informed consent from parents/legal representative, patient, and age-appropriate assent before any study-specific screening procedures are conducted according to local regional or national guidelines.
✓. Patient affiliated to a social security regimen or beneficiary of the same according to local requirements.

Exclusion criteria

What they're measuring

Event Free Survival (EFS)

Timeframe: From the randomisation into the VERITAS trial to 3 years

Trial details

NCT IDNCT03165292

SponsorGustave Roussy, Cancer Campus, Grand Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-28

View on ClinicalTrials.gov More Very High Risk Neuroblastoma trials