NANT Trials

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NANT provides children with relapsed and refractory high-risk neuroblastoma the opportunity to receive new investigational treatments when they have not responded to frontline therapy via NANT Phase 1-2 clinical trials. All NANT trials are based on laboratory data that show activity of the new treatment specifically against neuroblastoma. Our approach includes therapies that directly target the tumor cells, the normal surrounding cells that support tumor growth; and therapies that enhance the function of the patient’s immune system against tumor cells.

Patients are required to receive therapy on NANT trials at a NANT member site. NANT sites have a broad geographic distribution to help patients and families access our trials.

Active NANT Trials

Study Number

Short Name

Study Title

Study Chair

Participating Sites

NANT 2021-01

Phase 1 STING

Phase II study of ex-vivo expanded allogeneic universal donor TGFβi NK cell infusions in combination with temozolomide, irinotecan, dinutuximab and sargramostim in patients with relapsed or refractory neuroblastoma

The STING (Sequential Temozolomide, Irinotecan, NK cells and GD2 mAb) Trial

Keri Streby, MD

Mark Ranalli, MD

All full member sites + Nationwide Children's Hospital

NANT 2004-05

Biology Study

Neuroblastoma Biology Study

Shahab Asgharzadeh, MD

All full member sites + Nationwide Children’s Hospital

Enrollment/Treatment Completed

A list of publications is available here: Publications

PDF files of the manuscripts for trials indicated as published

are available at this link: NANT Manuscript Files - Google Drive

Study Number

Short Name

Study Title

Study Chair

Publication

NANT 2019-01

Phase 1 LY3295668

Phase 1 Study of Aurora Kinase A Inhibitor LY3295668 erbumine as a Single Agent and in Combination in Patients with Relapsed/Refractory Neuroblastoma

Steven DuBois MD

Manuscript in preparation

NANT 2017-01

Phase 1 MIBG + Dinutuximab

Phase 1 study of 131I-MIBG with Dinutuximab +/- vorinostat for Relapsed or Refractory Neuroblastoma

Steven DuBois, MD

Manuscript in preparation

NANT 2015-02

Phase 1 Lorlatinib +/- Cyclo/Topo

Phase 1 study of PF-06463922 (Lorlatinib), an oral small molecule inhibitor of ALK/ROS1, for patients with ALK-driven Relapsed or Refractory Neuroblastoma

Yael Mosse, MD

Published Goldsmith et al 2023; Berko et al 2023

NANT 2013-01

Phase 1 NK Cells + dinutuximab +/- lenalidomide

A Phase 1 Dose Escalation Study of Autologous Expanded Natural Killer (NK) Cells for Immunotherapy of Relapsed/Refractory Neuroblastoma with Dinutuximab +/- Lenalidomide

Araz Marachelian, MD

Manuscript in preparation

NANT 2015-01

Precision Trial

Neuroblastoma Precision Trial

Shahab Asgharzadeh, MD

Manuscript in preparation

NANT 2011-01

Phase 2 Randomized MIBG

Randomized Phase II Pick the Winner Study of 131I-MIBG, 131I-MIBG with Vincristine and Irinotecan, or 131I-MIBG with Vorinostat for Resistant/Relapsed Neuroblastoma

Steven DuBois, MD

Published DuBois et al 2021

NANT 2014-01

Phase I Study of SF1126

Phase I Study of SF1126 for Patients with Relapsed or Refractory Neuroblastoma

Steven DuBois, MD

Study stopped early; no publication

NANT 2013-02

Phase 1 Sorafenib+ Topo+ Cyclo

A Phase 1 Study of Sorafenib and Cyclophosphamide + Topotecan in Patients with Relapsed and Refractory Neuroblastoma

Margaret Macy, MD

Manuscript in preparation

NANT 2012-01

Phase 1 DFMO/ CTX/ Celecoxib

Phase 1 Study of Difluoromethylornithine (DFMO) and Celecoxib With Cyclophosphamide/Topotecan

Michael Hogarty, MD

Published Hogarty et al 2024

NANT 2011-04

Phase 1 Len +ch14.18

A Phase I Study Of Lenalidomide And Anti-GD2 Mab Ch14.18 +/- 13-Cis-Retinoic Acid in Patients With Refractory/ Recurrent Neuroblastoma

Araz Marachelian, MD

Manuscript in preparation

NANT 2009-03

MLN8237/ IRN/ TEM

Phase I/II Study of MLN8237 in Combination with Irinotecan and Temozolomide for Patients with Relapsed or Refractory Neuroblastoma

Steve Dubois, MD

Published DeBois et al 2018

NANT 2008-02

Vorinostat + isotretinoin

Phase I Study Of Vorinostat In Combination With 13 Cis-Retinoic Acid In Patients With Refractory/Recurrent Neuroblastoma

Julie Park, MD

Published Pinto et al 2018

NANT 2007-03

Vorinostat + MIBG

Vorinostat With 131I-MIBG Therapy For Resistant/Relapsed Neuroblastoma: A Phase I Study

Steve Dubois, MD

Published DeBois et al, 2015

NANT 2007-02

Cyclo+ Zometa + Bev

A Phase I Study Of Bevacizumab With Bolus And Metronomic Cyclophosphamide And Zoledronic Acid In Children With Recurrent Or Refractory Neuroblastoma

Julia Glade Bender, MD

Manuscript in preparation

NANT 2007-01

Ultratrace+ MIBG

A Phase I Study of UltratraceTM Iobenguane I 131 In Patients With Relapsed/Refractory High-Risk Neuroblastoma

Katherine Matthay, MD

Published Matthay et al 2012

NANT 2004-06

MIBG + IRN + VINC

Irinotecan and Vincristine with 131I-MIBG Therapy for Resistant/Relapsed High-Risk Neuroblastoma

Steve Dubois, MD

Published DeBois et al 2012

NANT 2004-04

LXS FEN

Phase I study of Fenretinide (4-HPR, NSC 374551) Lym-X Sorb TM (LXS) Oral Powder in Patients with Recurrent or Resistant Neuroblastoma

Barry Maurer, MD

Published Maurer et al 2013

NANT 2004-03

IV FEN

A Phase I study of Intravenous (Emulsion) Fenretinide (4-HPR, NSC 374551) in Children with Recurrent or Resistant Neuroblastoma

Barry Maurer, MD

Published Kang et al 2014

NANT 2004-01

Cyclo + Zometa

Study of Acid (Zometa TM) with Etoposide/Cyclophosphamide in Children with Recurrent Neuroblastoma

Heidi Russell, MD

Published Russel et al 2011

NANT 2003-01

IRN + TEM

A Phase I Study of Oral Irinotecan, Temozolomide, and Cefixime in Children with Recurrent/Resistant High-Risk Neuroblastoma

Lars Wagner, MD

Published Wagner et al 2009

NANT 2004-02

Dosimetry

Radiation Absorbed Dosimetry for 131I Meta-Iodobenzylguanide (131I-MIBG) Therapy

Gregory Yanik, MD

Published

NANT 2002-01

PZA

A Phase I Study of High-Dose Pyrazoloacridine (PZA) (NSC 366140) Supported with Autologous Hematopoietic Stem Cell Rescue in Children with Recurrent or Resistant Neuroblastoma.

Anna Butturini, MD

Study stopped early due to drug supply; not published.

NANT 2002-03

CEPH

Phase I Study of CEP-701 in Patients with Refractory Neuroblastoma

John Maris, MD

Published Minturn et al 2011

NANT 2001-02

N2001-02

131 I-Metaiodobenzyllguanidine (MIBG) with Intensive Chemotherapy and Autologous Stem Cell Rescue For High Risk Neuroblastoma.

Gregory Yanik, MD

Published Yanik et al 2015

NANT 2001-01

IL-12

A Phase I Investigation of IL-12 /Pulse IL-12 in Children with Persistent and/or Refractory Neuroblastoma.

Kenneth DeSantes, MD

Study stopped early due to drug supply; not published.

NANT 2000-01

Double MIBG

131 I-MIBG Escalating Dose Rapid Sequence Double Infusion Followed By Autologous Stem Cell Infusion for Refractory Neuroblastoma: Phase I Study.

Katherine Matthay, MD

Published 2009

NANT 1999-02

BSO + MEL

Modulation of Intensive Melphalan (L-PAM) by Buthionine Sulfoximine (BSO) (NSC-326321) with Autologous Stem Cell Support for Pediatric Extracranial Solid Tumors (NCI 68).

Samuel Volchenboum, MD

Published Villablanca et al 2016

NANT 1999-01

MIBG + CEM (phase 1)

Dose escalation Study Of 131 I-Metaiodobenzyllguanidine (MIBG) with Intensive Chemotherapy and Autologous Stem Cell Rescue For High Risk Neuroblastoma.

Katherine Matthay, MD

Published 2006