Clinical Trials /

A Study of N9 Chemotherapy in Children With Neuroblastoma

NCT04947501

Description:

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).

Related Conditions:
  • Neuroblastoma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of N9 Chemotherapy in Children With Neuroblastoma
  • Official Title: N9: Pilot Study of Novel Shortened Induction Chemotherapy for High-Risk Neuroblastoma

Clinical Trial IDs

  • ORG STUDY ID: 21-228
  • NCT ID: NCT04947501

Conditions

  • Neuroblastoma
  • Pediatric Cancer

Interventions

DrugSynonymsArms
CyclophosphamideCytoxanParticipants with newly-diagnosed HR-Neuroblastoma
TopotecanHycamtinParticipants with newly-diagnosed HR-Neuroblastoma
VincristineOncovinParticipants with newly-diagnosed HR-Neuroblastoma
DoxorubicinAdriamycinParticipants with newly-diagnosed HR-Neuroblastoma
IfosfamideIsophosphamideParticipants with newly-diagnosed HR-Neuroblastoma
EtoposideVePesid, EtopophosParticipants with newly-diagnosed HR-Neuroblastoma
CarboplatinParaplatinParticipants with newly-diagnosed HR-Neuroblastoma
MesnaMesnexParticipants with newly-diagnosed HR-Neuroblastoma

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Participants with newly-diagnosed HR-NeuroblastomaExperimentalThis pilot study of N9 as induction chemotherapy will enroll 15 patients with newly-diagnosed HR-NB.
  • Cyclophosphamide
  • Topotecan
  • Vincristine
  • Doxorubicin
  • Ifosfamide
  • Etoposide
  • Carboplatin
  • Mesna

Eligibility Criteria

        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 MYCN-nonamplified stage
             4 in patients >18 months old.

          -  No prior chemotherapy.

          -  Age >1 year to <13 years old.

          -  Organ function requirements:

        Adequate renal function defined as:

        Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m^2 or A serum creatinine based
        on age/sex as follows:

        Age: 1 to < 2 years Maximum Serum Creatinine (mg/dL): Male, 0.6; Female, 0.6 Age: 2 to < 6
        years Maximum Serum Creatinine (mg/dL): Male, 0.8; Female, 0.8 Age: 6 to ≤ 10 years Maximum
        Serum Creatinine (mg/dL): Male, 1; Female, 1

        The threshold creatinine values in this Table were derived from the Schwartz formula for
        estimating GFR utilizing child length and stature data published by the Centers for Disease
        Control.

        Adequate liver function defined as:

        Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age, and serum alanine
        aminotransferase (ALT) < 10 x ULN.

        Adequate cardiac function defined as:

        Shortening fraction of ≥ 27% by echocardiogram, or Ejection fraction of > 50% by
        echocardiogram or radionuclide angiogram.

          -  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.
      
Maximum Eligible Age:13 Years
Minimum Eligible Age:1 Year
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Assess safety of the N9 regimen in participants with HR-NB through toxicity assessment
Time Frame:16 weeks
Safety Issue:
Description:Adverse events will be graded using Common Toxicity Criteria Version 5.0 developed by the National Cancer Institute of the USA, events of all grades will be tabulated, for non-hematologic effects and hematologic effects on the patients in the safety set. The timing of cycles will also be described to assess any delay due to toxicity

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • HR-NB
  • Neuroblastoma
  • pediatric cancer
  • 21-228
  • Memorial Sloan Cancer Center

Last Updated

July 1, 2021