Health Trials

N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma

ConditionsHigh-risk NeuroblastomaNeuroblastomaChildhood Neuroblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-19
SponsorMemorial Sloan Kettering Cancer Center

About this trial

The purpose of this study is to find out whether N10 chemotherapy is a safe and effective treatment for children with high-risk neuroblastoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of NB as defined by histopathology, BM metastases plus high urine catecholamine levels, or positivity in MIBG scan.

HR-NB, defined as MYCN-amplified stage L2/M/MS at any age and stage M in patients >18 months old.

No more than one prior cycle of HR-NB chemotherapy

Age <19 years.

Disqualifiers

Severe dysfunction of major organs, i.e., renal, cardiac, hepatic, neurologic, pulmonary, hematologic, or gastrointestinal toxicity >/= to grade 3

Inability to comply with protocol requirements

Pregnancy

Trial design

Design model

Sequential

Treatments tested in this trial

  • DANYELZA

    Biological/Vaccine

    DANYELZA is a humanized monoclonal antibody of the IgG1 subclass

  • Sargramostim

    Biological/Vaccine

    Yeast derived recombinant human Sargramostim (GM-CSF)

  • Cytoxan

    Drug

    Cyclophosphamide is an alkylating agent related to nitrogen mustard

  • Topotecan

    Drug

    Topotecan is a topoisomerase I-inhibitor that is a semisynthetic derivative of camptothecin.

  • Vincristine

    Drug

    Vincristine is an alkaloid isolated from Vinca rosea Linn (periwinkle).

  • Doxorubicin

    Drug

    Doxorubicin is an anthracycline antibiotic

  • Ifosfamide

    Drug

    Ifosfamide is a structural analogue of cyclophosphamide

  • Etoposide

    Drug

    Etoposide for Injection is available as a 20 mg/mL solution in sterile multiple dose vials (5 mL, 25 mL, or 50 mL each).

  • Carboplatin

    Drug

    Carboplatin is available in 50 mg, 150 mg, 450 mg, and 600 mg vials.

  • Irinotecan

    Drug

    Irinotecan hydrochloride trihydrate (CPT-11) is a topoisomerase I inhibitor

  • Temozolomide

    Drug

    Temozolomide is administered intravenously

  • Radiation Therapy

    Radiation

    Between first and second cycle of antibody

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Participants with NeuroblastomaExperimental treatment 12 interventions

Trial outcomes

Primary outcomes

1

Evaluate participant response

To assess the early Complete Response/CR rate in newly-diagnosed HR-NB patients.

Time frame
After 2 cycles of mAb-based therapy (each cycle is 21 days)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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