Active — Not RecruitingEarly Phase 1

A Study of N9 Chemotherapy in Children With Neuroblastoma

United States26 participantsStarted 2021-06-22

Plain-language summary

The purpose of the study is to find out whether N9 is a safe and effective treatment for children with neuroblastoma. N9 includes 3 different combinations of chemotherapy drugs that are given at different times - Cyclophosphamide, topotecan, and vincristine (CTV), Ifosfamide, carboplatin, and etoposide (ICE), Cyclophosphamide, doxorubicin, and vincristine (CDV).

Who can participate

Age range1 Year – 19 Years

SexALL

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Inclusion Criteria: * Diagnosis of NB as defined by histopathology (confirmed by the MSK Department of Pathology), BM metastases plus high urine catecholamine levels, or positivity in MIBG scan. * HR-NB, defined as MYCN-amplified stage 2/3/4/4S at any age and stage 4 in patients \>18 months old. * No more than one prior cycle of chemotherapy. * Age \<19 years old. * Signed informed consent indicating awareness of the investigational nature of this treatment. Exclusion Criteria: * Severe dysfunction of major organs, i.e., renal, cardiac, hepatic, neurologic, pulmonary, hematologic, or gastrointestinal toxicity ≥ grade 3. * Inability to comply with protocol requirements. * Pregnancy is not an issue because all patients will be pre-adolescents.

What they're measuring

Assess safety of the N9 regimen in participants with HR-NB through toxicity assessment

Timeframe: 16 weeks

Trial details

NCT IDNCT04947501

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-22

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