CompletedPhase 2

Metronomic Treatment in Children and Adolescents With Recurrent or Progressive High Risk Neuroblastoma

Germany18 participantsStarted 2016-12-22

Plain-language summary

Neuroblastoma is the second most frequent cause for death from cancer in childhood. Already one year after diagnosis of recurrence from high risk neuroblastoma, 75% of the patients experience further progression. Metronomic therapy is targeting not only the tumor cell, but also the tumor supplying vasculature and the interactions between Tumor and immune cells. The toxicity is expected to be low due to the low (but continuous) dosing of drugs. The study investigates the tolerance and the efficacy of a new combination of five drugs consisting of propranolol (antiangiogenetic, anti-neuroblastic), Celecoxib (modulating immune response, ant-neuroblastic), cyclophosphamide (antiangiogenetic, anti-neuroblastic), etoposide (antiangiogenetic, anti-neuroblastic), and vinblastin (antiangiogenetic, anti-neuroblastic). Vinblastin is scheduled every 14 days intravenously, all other drugs are applied daily throughout 365 days (except etoposide for 4x3 weeks). The efficacies of each of the drugs have been demonstrated in vitro and in vivo in animal studies. All drugs have been used in children for other conditions. From those experiences low toxicities and a favorable Quality of life are expected.

Who can participate

Age range2 Years – 20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Newly diagnosed recurrence or progression of high risk neuroblastoma which progressed despite previous treatment (irrespective of the number of previous relapses/progressions). * Refractory and/or residual high-risk neuroblastoma with measurable or evaluable disease irrespective of preceding treatment (no Progression during the minimal interval as defined below) * Age: ≥ 2 years and \< 21 years * Measurable or evaluable disease defined as * Presence of at least one measurable (recurrent or newly progressing) neuroblastoma lesion ≥ 10 mm by magnetic resonance imaging (MRI) or computed tomography (CT) or * Newly detected unambiguous scintigraphic (MIBG) avid bone and/or medullary lesions * presence of unambiguous bone marrow metastasis * Minimal interval between start of trial medication and preceding anti-cancer treatment is 4 weeks after chemotherapy, 6 weeks after radiotherapy, and 12 weeks after myeloablative therapy * Life expectancy \> 3 months * Good to moderate general condition (performance scale ≥60) * No serious infection * Spontaneous recovering blood counts: * White blood cell count ≥ 1000/µL * Neutrophil count ≥ 500/µL * Platelet count ≥ 25 000/µL (unsupported) * Written informed consent of parents or legal guardian and/ or patient according to age and status of psycho-intellectual development. Exclusion Criteria: * Minimal residual disease status (only) without unambiguous measurable or evaluable disease * Patients unable to…

What they're measuring

non-inferiority of EFS compared to historical control group

Timeframe: up to 12 months

Trial details

NCT IDNCT02641314

SponsorUniversity of Cologne

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-29