A Phase II Study of Iodine 131-MIBG Alone and with Other Anticancer Drugs in Patients with Recurrent or Persistent Neuroblastoma

Full Title

Randomized Phase II Study of 131-I-MIBG vs. 131-I-MIBG with Vincristine and Irinotecan vs. 131-I-MIBG with Vorinostat for Resistant/Relapsed Neuroblastoma (NANT 2011-01)

Purpose

This study is evaluating the safety and effectiveness of radioactive iodine (131I) attached to an investigational drug called MIBG, alone and in combination with other anticancer drugs, to treat neuroblastoma that has come back or continued to grow despite other therapies. 131I-MIBG delivers radiation directly to neuroblastoma cells throughout the body.

Patients in this study will be randomly assigned to receive one of these treatments:

  • 131I-MIBG alone
  • 131I-MIBG plus the drugs vincristine and irinotecan
  • 131I-MIBG plus vorinostat

Vincristine, irinotecan, and vorinostat are used to treat other forms of cancer; their use in this study is considered investigational. 131I-MIBG, vincristine, and irinotecan are given intravenously (by vein), and vorinostat is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have neuroblastoma that has come back or continued to grow despite therapy.
  • Patients must recover from the serious side effects of prior therapies before entering the study.
  • This study is for patients between the ages of 1 and 30 years.

For more information about this study and to inquire about eligibility, please contact Dr. Stephen Roberts at 212-639-4034.

Protocol

16-226

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Diseases

Locations