NANT 2021-02: A Randomized Phase 2 Study of 131I-MIBG With Vorinostat VS. 131I-MIBG With Dinutuximab vs. 131I-MIBG With Dinutuximab and Vorinostat for Relapsed or Refractory Neuroblastoma

Summary

Patients will then be randomized at study entry to one of three treatment arms. Patients on Arm A will receive a single treatment course with 131I-MIBG with vorinostat. Patients on Arm B will receive a single treatment course with 131I-MIBG and dinutuximab. Patients on Arm C will receive a single treatment course with 131I-MIBG with dinutuximab + vorinostat. After this course of treatment, we will check to see your response and then check to see how you are doing over time. All patients may choose to proceed to a second course of the same treatment if they and their physician feel healthy enough to do so. Approximately 118 patients will be receiving therapy on this trial.

Description

Eligibility

Age range

1–30 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Radiation: 131I-MIBG

  Patients will receive 131I-MIBG 18 mCi/kg (maximum dose 1200 mCi) on Day 1

• Drug
  Dinutuximab

  Dinutuximab 17.5 mg/m2/day is given intravenously on Days 8-11 and 29-32 of therapy

• Drug
  Vorinostat

  Vorinostat will be given on days 0-13 at a dose of 180 mg/m2/dose (maximum dose 400 mg).

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