131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinostat

NCT02035137 ↗

Phase 2 Completed 114 enrolled New Approaches to Neuroblastoma Therapy Consortium

RandomizedParallel-groupOpen-labelTreatment

Summary

This study will compare three treatment regimens containing metaiodobenzylguanidine (MIBG) and compare their effects on tumor response and associated side effects, to determine if one therapy is better than the other for people diagnosed with relapsed or persistent neuroblastoma.

Timeline

Start: 2014-07
Primary completion: 2021-02-26
Completion: 2021-02-26

Publications

DuBois SG, Granger MM, Groshen S, Tsao-Wei D, Ji L, Shamirian A, Czarnecki S, Goodarzian F, Berkovich R, Shimada H, Villablanca JG, Vo KT, Pinto N, Mosse YP, Maris JM, Shusterman S, Cohn SL, Goldsmith KC, Weiss B, Yanik GA, Twist CJ, Irwin MS, Haas-Kogan DA, Park JR, Marachelian A, Matthay KK. Randomized Phase II Trial of MIBG Versus MIBG, Vincristine, and Irinotecan Versus MIBG and Vorinostat for Patients With Relapsed or Refractory Neuroblastoma: A Report From NANT Consortium. J Clin Oncol. 2021 Nov 1;39(31):3506-3514. doi: 10.1200/JCO.21.00703. Epub 2021 Jul 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Irinotecan	Small molecule	50 mg/m2	Intravenous
Comparator	Vincristine	Small molecule	2 mg/m2	Intravenous
Comparator	Vorinostat	Small molecule	180 mg/m2	Oral

131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinostat

Summary

Timeline

Publications

Drugs

Indications