A Study of Therapeutic Iobenguane (131-I) and Vorinostat for Recurrent or Progressive High-Risk Neuroblastoma Subjects

Conditions

• Neoplasms
• Neuroblastoma
• Neuroectodermal Tumors

Eligibility Criteria

Sex

ALL

Age

1 Year - N/A

Healthy Volunteers

Not accepted

Interventions

• 131I-MIBG — DRUG
  Subjects will receive 18 mCi/kg of 131I-MIBG administered over 1.5 to 2 hours on Day 1 either a central line or a peripheral intravenous catheter. The maximum absolute dose of 131I-MIBG is determined by institution therapeutic limits and will not exceed 1,000 mCi. Subjects with an overall response of stable disease or better as assessed by the Investigator, and who meet certain protocol predefined criteria, may receive a second 18 mCi/kg 131I-MIBG treatment no sooner than 6 weeks following the first treatment.
• 131-MIBG + Vorinostat — DRUG
  Subjects will receive vorinostat 180 mg/m2/dose (maximum dose 400 mg) once daily by mouth, NG, or G-tube on days -1 to +12 (14 total doses) for 14 days continuously. The 131I-MIBG treatment will be administered on day 1 via either a central line or a peripheral intravenous catheter over 1.5 to 2 hours. On day 1 of therapy, vorinostat should be taken 1 hour prior to the start of the 131I-MIBG infusion. Subjects with an overall response of stable disease or better, as assessed by the Investigator and who meet certain predefined criteria, may receive a second course of 18 mCi/kg 131I-MIBG combined with vorinostat (180 mg/m2) no sooner than 6 weeks following the first therapeutic 131I-MIBG treatment.

Study Details

The purpose of this study is to evaluate the efficacy and safety of 131I-MIBG in combination with Vorinostat in patients with Recurrent or Progressive neuroblastoma

Key Dates

Start date

Oct 21, 2019

Status verified

Feb 2023

Primary completion

Dec 1, 2023

Completion

Apr 30, 2025

Study Design

Enrollment

60 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: 131I-MIBG
  131I-MIBG
• Experimental: 131I-MIBG + Vorinostat
  131I-MIBG + Vorinostat

Primary Outcome Measure

Overall Response [ Time Frame: 6 weeks after the last 131I-MIBG treatment which will either be the first or the second treatment course (131I-MIBG + vorinostat) and a confirmatory assessment at least 6 weeks thereafter (at least 12 weeks from the end of treatment) ]

Central Contacts

• Melda Dolan, MD
  1-215-930-4550
  [email protected]
• Suzanne Bissonnette
  215-406-0127
  [email protected]

Locations (21)

Find similar trials in Palo Alto, CA

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