NANT 2021-02: Randomized MIBG With Vorinostat/Dinutuximab/Vorinostat + Dinutuximab

Conditions

• Neuroblastoma

Eligibility Criteria

Sex

ALL

Age

1 Year - 30 Years

Healthy Volunteers

Not accepted

Interventions

• Radiation: 131I-MIBG — DRUG
  Patients will receive 131I-MIBG 18 mCi/kg (maximum dose 1200 mCi) on Day 1
• Dinutuximab — DRUG
  Dinutuximab 17.5 mg/m2/day is given intravenously on Days 8-11 and 29-32 of therapy
• Vorinostat — DRUG
  Vorinostat will be given on days 0-13 at a dose of 180 mg/m2/dose (maximum dose 400 mg).

Study Details

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.

Key Dates

Start date

Jul 31, 2026

Status verified

Nov 2025

Primary completion

Jul 31, 2030

Completion

Jul 31, 2031

Study Design

Enrollment

118 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: 131I-MIBG + vorinostat
  Patients assigned to Arm A will receive vorinostat orally once daily on Days 0 to 13 at a dose of 180 mg/m2/dose (maximum dose 400 mg). Patients will receive 131I-MIBG 18 mCi/kg (maximum dose 1200 mCi) on Day 1 and autologous stem cell infusion on Day 15 (plus 2 days or minus 1 day, hereafter abbreviated as +2/-1 days). There must be at least 24 hours between the last dose of vorinostat and stem cell infusion. Disease evaluation is to occur between days 50-60. The time interval between performing end of Course 1 disease evaluation and administration of Course 2 131I-MIBG is not to exceed 4 weeks.
• Experimental: Arm B: 131I-MIBG + dinutuximab
  Patients assigned to Arm B will receive 18 mCi/kg (maximum dose 1200 mCi) 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15 (+2/-1 days). Dinutuximab 17.5 mg/m2/day is given intravenously on Days 8-11 and 29-32 of therapy. Disease evaluation is to occur between Days 50-60. In case of treatment delays with dinutuximab during Course 1, the time interval between performing end of Course 1 disease evaluation and administration of Course 2 131I-MIBG is not to exceed 4 weeks.
• Experimental: Arm C: 131I-MIBG + vorinostat + dinutuximab
  Patients assigned to Arm C will receive vorinostat 180 mg/m2/dose (maximum dose 400 mg) on Days 0 to 13, 131I-MIBG 18 mCi/kg (maximum dose 1200 mCi) on Day 1. Dinutuximab 17.5 mg/m2/day is given intravenously on Days 8-11 and 29-32 of therapy. Disease evaluation is to occur between Days 50-60. In case of treatment delays with dinutuximab during Course 1, the time interval between performing end of Course 1 disease evaluation and administration of Course 2 131I-MIBG is not to exceed 4 weeks.

Primary Outcome Measure

Objective Tumor Response After One Course of Therapy [ Time Frame: 43-50 days from study day 1 ]

Central Contacts

• Araz Marachelian, MD
  323-361-5687
  [email protected]

Locations (13)

Find similar trials in Los Angeles, CA

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