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Iobenguane I-131 or Crizotinib and Standard Therapy in Treating Younger Patients With Newly-Diagnosed High-Risk Neuroblastoma or Ganglioneuroblastoma

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ClinicalTrials.gov Identifier: NCT03126916
Recruitment Status : Recruiting
First Posted : April 25, 2017
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:
This phase III trial studies iobenguane I-131 or crizotinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Crizotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or crizotinib and standard therapy may work better in treating younger patients with neuroblastoma or ganglioneuroblastoma.

Condition or disease Intervention/treatment Phase
Ganglioneuroblastoma INRG Stage L2 INRG Stage M INRG Stage MS Neuroblastoma NMYC Gene Amplification Recurrent Neuroblastoma Biological: Aldesleukin Procedure: Autologous Hematopoietic Stem Cell Transplantation Drug: Busulfan Drug: Carboplatin Drug: Cisplatin Drug: Crizotinib Drug: Cyclophosphamide Drug: Dexrazoxane Hydrochloride Biological: Dinutuximab Drug: Doxorubicin Hydrochloride Drug: Etoposide Phosphate Radiation: External Beam Radiation Therapy Radiation: Iobenguane I-131 Drug: Isotretinoin Other: Laboratory Biomarker Analysis Drug: Melphalan Other: Pharmacological Study Biological: Sargramostim Procedure: Therapeutic Conventional Surgery Drug: Thiotepa Drug: Topotecan Hydrochloride Drug: Vincristine Sulfate Phase 3

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 813 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL)
Actual Study Start Date : May 9, 2018
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma
Drug Information available for: Crizotinib

Arm Intervention/treatment
Experimental: Arm A (chemotherapy, HSCT, EBRT)
See Arm A in detailed description.
Biological: Aldesleukin
Given IV
Other Names:
  • 125-L-Serine-2-133-interleukin 2
  • Proleukin
  • r-serHuIL-2
  • Recombinant Human IL-2
  • Recombinant Human Interleukin-2

Procedure: Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous HSCT
Other Names:
  • Autologous Hematopoietic Cell Transplantation
  • autologous stem cell transplantation

Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carboplatinum
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo

Drug: Cisplatin
Given IV
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone''s Chloride
  • Peyrone''s Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin

Drug: Cyclophosphamide
Given IV
Other Names:
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrate
  • CTX
  • CYCLO-cell
  • Cycloblastin
  • Cycloblastine
  • Cyclophospham
  • Cyclophosphamid monohydrate
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Cytoxan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719

Drug: Dexrazoxane Hydrochloride
Given IV
Other Names:
  • Cardioxane
  • Totect
  • Zinecard

Biological: Dinutuximab
Given IV
Other Names:
  • Ch 14.18UTC
  • Ch14.18
  • MOAB Ch14.18
  • monoclonal antibody Ch14.18
  • Unituxin

Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex

Drug: Etoposide Phosphate
Given IV
Other Name: Etopophos

Radiation: External Beam Radiation Therapy
Undergo EBRT
Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation

Drug: Isotretinoin
Given PO
Other Names:
  • 13-cis retinoic acid
  • 13-cis-Retinoate
  • 13-cis-Retinoic Acid
  • 13-cis-Vitamin A Acid
  • 13-cRA
  • Absorica
  • Accure
  • Accutane
  • Amnesteem
  • cis-Retinoic Acid
  • Cistane
  • Claravis
  • Isotretinoinum
  • Isotrex
  • Isotrexin
  • Myorisan
  • Neovitamin A
  • Neovitamin A Acid
  • Oratane
  • Retinoicacid-13-cis
  • Ro 4-3780
  • Ro-4-3780
  • Roaccutan
  • Roaccutane
  • Roacutan
  • Sotret
  • ZENATANE

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Pharmacological Study
Correlative studies

Biological: Sargramostim
Given SC
Other Names:
  • 23-L-Leucinecolony-Stimulating Factor 2
  • DRG-0012
  • Leukine
  • Prokine
  • rhu GM-CFS
  • Sagramostim
  • Sargramostatin

Procedure: Therapeutic Conventional Surgery
Undergo standard of care surgery

Drug: Thiotepa
Given IV
Other Names:
  • 1,1'',1''''-Phosphinothioylidynetrisaziridine
  • Girostan
  • N,N'', N''''-Triethylenethiophosphoramide
  • Oncotiotepa
  • STEPA
  • Tepadina
  • TESPA
  • Tespamin
  • Tespamine
  • Thio-Tepa
  • Thiofosfamide
  • Thiofozil
  • Thiophosphamide
  • Thiophosphoramide
  • Thiotef
  • Tifosyl
  • TIO TEF
  • Tio-tef
  • Triethylene thiophosphoramide
  • Triethylenethiophosphoramide
  • Tris(1-aziridinyl)phosphine sulfide
  • TSPA
  • WR 45312

Drug: Topotecan Hydrochloride
Given IV
Other Names:
  • Hycamptamine
  • Hycamtin
  • SKF S-104864-A
  • Topotecan HCl
  • topotecan hydrochloride (oral)

Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Leurocristine sulfate
  • Leurocristine, sulfate
  • Oncovin
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristine, sulfate

Experimental: Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)
See Arm B in detailed description.
Biological: Aldesleukin
Given IV
Other Names:
  • 125-L-Serine-2-133-interleukin 2
  • Proleukin
  • r-serHuIL-2
  • Recombinant Human IL-2
  • Recombinant Human Interleukin-2

Procedure: Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous HSCT
Other Names:
  • Autologous Hematopoietic Cell Transplantation
  • autologous stem cell transplantation

Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carboplatinum
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo

Drug: Cisplatin
Given IV
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone''s Chloride
  • Peyrone''s Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin

Drug: Cyclophosphamide
Given IV
Other Names:
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrate
  • CTX
  • CYCLO-cell
  • Cycloblastin
  • Cycloblastine
  • Cyclophospham
  • Cyclophosphamid monohydrate
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Cytoxan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719

Drug: Dexrazoxane Hydrochloride
Given IV
Other Names:
  • Cardioxane
  • Totect
  • Zinecard

Biological: Dinutuximab
Given IV
Other Names:
  • Ch 14.18UTC
  • Ch14.18
  • MOAB Ch14.18
  • monoclonal antibody Ch14.18
  • Unituxin

Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex

Drug: Etoposide Phosphate
Given IV
Other Name: Etopophos

Radiation: External Beam Radiation Therapy
Undergo EBRT
Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation

Radiation: Iobenguane I-131
Given IV
Other Names:
  • (131)I-MIBG
  • 131I-MIBG
  • I 131 Meta-iodobenzylguanidine
  • I-131 Metaiodobenzylguanidine
  • Iobenguane I 131
  • Iodine I 131 Metaiodobenzylguanidine
  • MIBG I-131

Drug: Isotretinoin
Given PO
Other Names:
  • 13-cis retinoic acid
  • 13-cis-Retinoate
  • 13-cis-Retinoic Acid
  • 13-cis-Vitamin A Acid
  • 13-cRA
  • Absorica
  • Accure
  • Accutane
  • Amnesteem
  • cis-Retinoic Acid
  • Cistane
  • Claravis
  • Isotretinoinum
  • Isotrex
  • Isotrexin
  • Myorisan
  • Neovitamin A
  • Neovitamin A Acid
  • Oratane
  • Retinoicacid-13-cis
  • Ro 4-3780
  • Ro-4-3780
  • Roaccutan
  • Roaccutane
  • Roacutan
  • Sotret
  • ZENATANE

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Pharmacological Study
Correlative studies

Biological: Sargramostim
Given SC
Other Names:
  • 23-L-Leucinecolony-Stimulating Factor 2
  • DRG-0012
  • Leukine
  • Prokine
  • rhu GM-CFS
  • Sagramostim
  • Sargramostatin

Procedure: Therapeutic Conventional Surgery
Undergo standard of care surgery

Drug: Thiotepa
Given IV
Other Names:
  • 1,1'',1''''-Phosphinothioylidynetrisaziridine
  • Girostan
  • N,N'', N''''-Triethylenethiophosphoramide
  • Oncotiotepa
  • STEPA
  • Tepadina
  • TESPA
  • Tespamin
  • Tespamine
  • Thio-Tepa
  • Thiofosfamide
  • Thiofozil
  • Thiophosphamide
  • Thiophosphoramide
  • Thiotef
  • Tifosyl
  • TIO TEF
  • Tio-tef
  • Triethylene thiophosphoramide
  • Triethylenethiophosphoramide
  • Tris(1-aziridinyl)phosphine sulfide
  • TSPA
  • WR 45312

Drug: Topotecan Hydrochloride
Given IV
Other Names:
  • Hycamptamine
  • Hycamtin
  • SKF S-104864-A
  • Topotecan HCl
  • topotecan hydrochloride (oral)

Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Leurocristine sulfate
  • Leurocristine, sulfate
  • Oncovin
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristine, sulfate

Experimental: Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)
See Arm C in detailed description.
Biological: Aldesleukin
Given IV
Other Names:
  • 125-L-Serine-2-133-interleukin 2
  • Proleukin
  • r-serHuIL-2
  • Recombinant Human IL-2
  • Recombinant Human Interleukin-2

Procedure: Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous HSCT
Other Names:
  • Autologous Hematopoietic Cell Transplantation
  • autologous stem cell transplantation

Drug: Busulfan
Given IV
Other Names:
  • 1, 4-Bis[methanesulfonoxy]butane
  • BUS
  • Bussulfam
  • Busulfanum
  • Busulfex
  • Busulphan
  • CB 2041
  • CB-2041
  • Glyzophrol
  • GT 41
  • GT-41
  • Joacamine
  • Methanesulfonic Acid Tetramethylene Ester
  • Methanesulfonic acid, tetramethylene ester
  • Mielucin
  • Misulban
  • Misulfan
  • Mitosan
  • Myeleukon
  • Myeloleukon
  • Myelosan
  • Mylecytan
  • Myleran
  • Sulfabutin
  • Tetramethylene Bis(methanesulfonate)
  • Tetramethylene bis[methanesulfonate]
  • WR-19508

Drug: Cisplatin
Given IV
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone''s Chloride
  • Peyrone''s Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin

Drug: Cyclophosphamide
Given IV
Other Names:
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrate
  • CTX
  • CYCLO-cell
  • Cycloblastin
  • Cycloblastine
  • Cyclophospham
  • Cyclophosphamid monohydrate
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Cytoxan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719

Drug: Dexrazoxane Hydrochloride
Given IV
Other Names:
  • Cardioxane
  • Totect
  • Zinecard

Biological: Dinutuximab
Given IV
Other Names:
  • Ch 14.18UTC
  • Ch14.18
  • MOAB Ch14.18
  • monoclonal antibody Ch14.18
  • Unituxin

Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex

Drug: Etoposide Phosphate
Given IV
Other Name: Etopophos

Radiation: External Beam Radiation Therapy
Undergo EBRT
Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation

Radiation: Iobenguane I-131
Given IV
Other Names:
  • (131)I-MIBG
  • 131I-MIBG
  • I 131 Meta-iodobenzylguanidine
  • I-131 Metaiodobenzylguanidine
  • Iobenguane I 131
  • Iodine I 131 Metaiodobenzylguanidine
  • MIBG I-131

Drug: Isotretinoin
Given PO
Other Names:
  • 13-cis retinoic acid
  • 13-cis-Retinoate
  • 13-cis-Retinoic Acid
  • 13-cis-Vitamin A Acid
  • 13-cRA
  • Absorica
  • Accure
  • Accutane
  • Amnesteem
  • cis-Retinoic Acid
  • Cistane
  • Claravis
  • Isotretinoinum
  • Isotrex
  • Isotrexin
  • Myorisan
  • Neovitamin A
  • Neovitamin A Acid
  • Oratane
  • Retinoicacid-13-cis
  • Ro 4-3780
  • Ro-4-3780
  • Roaccutan
  • Roaccutane
  • Roacutan
  • Sotret
  • ZENATANE

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Melphalan
Given IV
Other Names:
  • Alanine Nitrogen Mustard
  • CB-3025
  • L-PAM
  • L-Phenylalanine Mustard
  • L-sarcolysin
  • L-Sarcolysin Phenylalanine mustard
  • L-Sarcolysine
  • Melphalanum
  • Phenylalanine Mustard
  • Phenylalanine nitrogen mustard
  • Sarcoclorin
  • Sarkolysin
  • WR-19813

Other: Pharmacological Study
Correlative studies

Biological: Sargramostim
Given SC
Other Names:
  • 23-L-Leucinecolony-Stimulating Factor 2
  • DRG-0012
  • Leukine
  • Prokine
  • rhu GM-CFS
  • Sagramostim
  • Sargramostatin

Procedure: Therapeutic Conventional Surgery
Undergo standard of care surgery

Drug: Thiotepa
Given IV
Other Names:
  • 1,1'',1''''-Phosphinothioylidynetrisaziridine
  • Girostan
  • N,N'', N''''-Triethylenethiophosphoramide
  • Oncotiotepa
  • STEPA
  • Tepadina
  • TESPA
  • Tespamin
  • Tespamine
  • Thio-Tepa
  • Thiofosfamide
  • Thiofozil
  • Thiophosphamide
  • Thiophosphoramide
  • Thiotef
  • Tifosyl
  • TIO TEF
  • Tio-tef
  • Triethylene thiophosphoramide
  • Triethylenethiophosphoramide
  • Tris(1-aziridinyl)phosphine sulfide
  • TSPA
  • WR 45312

Drug: Topotecan Hydrochloride
Given IV
Other Names:
  • Hycamptamine
  • Hycamtin
  • SKF S-104864-A
  • Topotecan HCl
  • topotecan hydrochloride (oral)

Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Leurocristine sulfate
  • Leurocristine, sulfate
  • Oncovin
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristine, sulfate

Experimental: Arm D (chemotherapy, HSCT, EBRT)
See Arm D in detailed description.
Biological: Aldesleukin
Given IV
Other Names:
  • 125-L-Serine-2-133-interleukin 2
  • Proleukin
  • r-serHuIL-2
  • Recombinant Human IL-2
  • Recombinant Human Interleukin-2

Procedure: Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous HSCT
Other Names:
  • Autologous Hematopoietic Cell Transplantation
  • autologous stem cell transplantation

Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carboplatinum
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo

Drug: Cisplatin
Given IV
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone''s Chloride
  • Peyrone''s Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin

Drug: Cyclophosphamide
Given IV
Other Names:
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrate
  • CTX
  • CYCLO-cell
  • Cycloblastin
  • Cycloblastine
  • Cyclophospham
  • Cyclophosphamid monohydrate
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Cytoxan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719

Drug: Dexrazoxane Hydrochloride
Given IV
Other Names:
  • Cardioxane
  • Totect
  • Zinecard

Biological: Dinutuximab
Given IV
Other Names:
  • Ch 14.18UTC
  • Ch14.18
  • MOAB Ch14.18
  • monoclonal antibody Ch14.18
  • Unituxin

Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex

Drug: Etoposide Phosphate
Given IV
Other Name: Etopophos

Radiation: External Beam Radiation Therapy
Undergo EBRT
Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation

Drug: Isotretinoin
Given PO
Other Names:
  • 13-cis retinoic acid
  • 13-cis-Retinoate
  • 13-cis-Retinoic Acid
  • 13-cis-Vitamin A Acid
  • 13-cRA
  • Absorica
  • Accure
  • Accutane
  • Amnesteem
  • cis-Retinoic Acid
  • Cistane
  • Claravis
  • Isotretinoinum
  • Isotrex
  • Isotrexin
  • Myorisan
  • Neovitamin A
  • Neovitamin A Acid
  • Oratane
  • Retinoicacid-13-cis
  • Ro 4-3780
  • Ro-4-3780
  • Roaccutan
  • Roaccutane
  • Roacutan
  • Sotret
  • ZENATANE

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Pharmacological Study
Correlative studies

Biological: Sargramostim
Given SC
Other Names:
  • 23-L-Leucinecolony-Stimulating Factor 2
  • DRG-0012
  • Leukine
  • Prokine
  • rhu GM-CFS
  • Sagramostim
  • Sargramostatin

Procedure: Therapeutic Conventional Surgery
Undergo standard of care surgery

Drug: Thiotepa
Given IV
Other Names:
  • 1,1'',1''''-Phosphinothioylidynetrisaziridine
  • Girostan
  • N,N'', N''''-Triethylenethiophosphoramide
  • Oncotiotepa
  • STEPA
  • Tepadina
  • TESPA
  • Tespamin
  • Tespamine
  • Thio-Tepa
  • Thiofosfamide
  • Thiofozil
  • Thiophosphamide
  • Thiophosphoramide
  • Thiotef
  • Tifosyl
  • TIO TEF
  • Tio-tef
  • Triethylene thiophosphoramide
  • Triethylenethiophosphoramide
  • Tris(1-aziridinyl)phosphine sulfide
  • TSPA
  • WR 45312

Drug: Topotecan Hydrochloride
Given IV
Other Names:
  • Hycamptamine
  • Hycamtin
  • SKF S-104864-A
  • Topotecan HCl
  • topotecan hydrochloride (oral)

Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Leurocristine sulfate
  • Leurocristine, sulfate
  • Oncovin
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristine, sulfate

Experimental: Arm E (crizotinib, chemotherapy, HSCT, EBRT)
See Arm E in detailed description.
Biological: Aldesleukin
Given IV
Other Names:
  • 125-L-Serine-2-133-interleukin 2
  • Proleukin
  • r-serHuIL-2
  • Recombinant Human IL-2
  • Recombinant Human Interleukin-2

Procedure: Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous HSCT
Other Names:
  • Autologous Hematopoietic Cell Transplantation
  • autologous stem cell transplantation

Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carboplatinum
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo

Drug: Cisplatin
Given IV
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone''s Chloride
  • Peyrone''s Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin

Drug: Crizotinib
Given PO
Other Names:
  • MET Tyrosine Kinase Inhibitor PF-02341066
  • PF-02341066
  • PF-2341066
  • Xalkori

Drug: Cyclophosphamide
Given IV
Other Names:
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrate
  • CTX
  • CYCLO-cell
  • Cycloblastin
  • Cycloblastine
  • Cyclophospham
  • Cyclophosphamid monohydrate
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Cytoxan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719

Drug: Dexrazoxane Hydrochloride
Given IV
Other Names:
  • Cardioxane
  • Totect
  • Zinecard

Biological: Dinutuximab
Given IV
Other Names:
  • Ch 14.18UTC
  • Ch14.18
  • MOAB Ch14.18
  • monoclonal antibody Ch14.18
  • Unituxin

Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex

Drug: Etoposide Phosphate
Given IV
Other Name: Etopophos

Radiation: External Beam Radiation Therapy
Undergo EBRT
Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation

Drug: Isotretinoin
Given PO
Other Names:
  • 13-cis retinoic acid
  • 13-cis-Retinoate
  • 13-cis-Retinoic Acid
  • 13-cis-Vitamin A Acid
  • 13-cRA
  • Absorica
  • Accure
  • Accutane
  • Amnesteem
  • cis-Retinoic Acid
  • Cistane
  • Claravis
  • Isotretinoinum
  • Isotrex
  • Isotrexin
  • Myorisan
  • Neovitamin A
  • Neovitamin A Acid
  • Oratane
  • Retinoicacid-13-cis
  • Ro 4-3780
  • Ro-4-3780
  • Roaccutan
  • Roaccutane
  • Roacutan
  • Sotret
  • ZENATANE

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Pharmacological Study
Correlative studies

Biological: Sargramostim
Given SC
Other Names:
  • 23-L-Leucinecolony-Stimulating Factor 2
  • DRG-0012
  • Leukine
  • Prokine
  • rhu GM-CFS
  • Sagramostim
  • Sargramostatin

Procedure: Therapeutic Conventional Surgery
Undergo standard of care surgery

Drug: Thiotepa
Given IV
Other Names:
  • 1,1'',1''''-Phosphinothioylidynetrisaziridine
  • Girostan
  • N,N'', N''''-Triethylenethiophosphoramide
  • Oncotiotepa
  • STEPA
  • Tepadina
  • TESPA
  • Tespamin
  • Tespamine
  • Thio-Tepa
  • Thiofosfamide
  • Thiofozil
  • Thiophosphamide
  • Thiophosphoramide
  • Thiotef
  • Tifosyl
  • TIO TEF
  • Tio-tef
  • Triethylene thiophosphoramide
  • Triethylenethiophosphoramide
  • Tris(1-aziridinyl)phosphine sulfide
  • TSPA
  • WR 45312

Drug: Topotecan Hydrochloride
Given IV
Other Names:
  • Hycamptamine
  • Hycamtin
  • SKF S-104864-A
  • Topotecan HCl
  • topotecan hydrochloride (oral)




Primary Outcome Measures :
  1. Event free survival (EFS) (Arm A, B, D, and E) [ Time Frame: 3 years ]
    EFS time is calculated from date of randomization or assignment to first episode of disease relapse or progression, second malignancy, or death, or until last contact if no event has occurred.


Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 18 months for Arms A-D and 28 months for Arm E ]
    The proportion of patients with at least one Grade 3 or higher toxicity during protocol therapy, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, will be reported.

  2. Event-free survival (EFS) (Arm C) [ Time Frame: 3 years ]
    EFS time is calculated from date of randomization to first episode of disease relapse or progression, second malignancy, or death, or until last contact if no event has occurred.

  3. Overall survival (OS) [ Time Frame: 3 years ]
    OS time is calculated from date of randomization or assignment until death, or until last contact if patient is alive.

  4. Response rate [ Time Frame: Up to 6 months ]
    The response rate will be calculated among all evaluable patients at end-Induction. Responders are defined as patients who achieve a >= partial response (PR) per the revised International Neuroblastoma Response Criteria (INRC).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   365 Days to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be enrolled on ANBL00B1 or APEC14B1 prior to enrollment on ANBL1531
  • Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites; the following disease groups are eligible:

    • Patients with International Neuroblastoma Risk Group (INRG) stage M disease are eligible if found to have either of the following features:

      • MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features; OR
      • Age > 547 days regardless of biologic features
    • Patients with INRG stage MS disease with MYCN amplification
    • Patients with INRG stage L2 disease with MYCN amplification
    • Patients > 547 days of age initially diagnosed with INRG stage L1, L2 or MS disease who progressed to Stage M without prior chemotherapy may enroll within 4 weeks of progression to Stage M
    • Patients >= 365 days of age initially diagnosed with MYCN amplified INRG stage L1 disease who progress to Stage M without systemic therapy may enroll within 4 weeks of progression to stage M
  • Patients initially recognized to have high-risk disease must have had no prior systemic therapy (other than topotecan/cyclophosphamide initiated on an emergent basis and within allowed timing); patients observed or treated with a single cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (e.g., as per ANBL0531, ANBL1232 or similar) for what initially appeared to be non-high risk disease but subsequently found to meet the criteria will also be eligible; patients who receive localized emergency radiation to sites of life-threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis will be eligible
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/sex as follows:

    • 1 to < 2 years: male = 0.6; female = 0.6
    • 2 to < 6 years: male = 0.8; female = 0.8
    • 6 to < 10 years: male = 1; female = 1
    • 10 to < 13 years: male = 1.2; female = 1.2
    • 13 to < 16 years: male = 1.5; female = 1.4
    • >= 16 years: male = 1.7; female = 1.4
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, and
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 10 x ULN; for the purposes of this study, ULN for SGPT (ALT) is 45
  • Shortening fraction of >= 27% by echocardiogram, or ejection fraction of > 50% by echocardiogram or radionuclide angiogram
  • No known contraindication to peripheral blood stem cell (PBSC) collection; examples of contraindications might be a weight or size less than the collecting institution finds feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure

Exclusion Criteria:

  • Patients with INRG stage L2 tumors without amplification of MYCN regardless of tumor histology (may meet criteria for may meet criteria for high risk classification but are not eligible for this trial)
  • Patients with bone marrow failure syndromes
  • Patients for whom targeted radiopharmaceutical therapy would be contraindicated due to underlying medical disorders
  • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential
  • Lactating females who plan to breastfeed their infants
  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126916


  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
Children's Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Site Public Contact    205-638-9285    oncologyresearch@peds.uab.edu   
Principal Investigator: Matthew A. Kutny         
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202-3591
Contact: Site Public Contact    501-364-7373      
Principal Investigator: David L. Becton         
United States, California
Kaiser Permanente Downey Medical Center Recruiting
Downey, California, United States, 90242
Contact: Site Public Contact    626-564-3455      
Principal Investigator: Robert M. Cooper         
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Site Public Contact    909-558-3375      
Principal Investigator: Albert Kheradpour         
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Site Public Contact    323-361-4110      
Principal Investigator: Leo Mascarenhas         
Mattel Children's Hospital UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Site Public Contact    310-825-6708      
Principal Investigator: William A. May         
Valley Children's Hospital Recruiting
Madera, California, United States, 93636
Contact: Site Public Contact    559-353-3000    Research@valleychildrens.org   
Principal Investigator: Vonda L. Crouse         
Kaiser Permanente-Oakland Recruiting
Oakland, California, United States, 94611
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Laura A. Campbell         
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
Contact: Site Public Contact    714-997-3000      
Principal Investigator: Elyssa M. Rubin         
Lucile Packard Children's Hospital Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Site Public Contact    800-694-0012    ccto-office@stanford.edu   
Principal Investigator: Jay Michael S. Balagtas         
University of California Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Site Public Contact    916-734-3089      
Principal Investigator: Marcio H. Malogolowkin         
UCSF Medical Center-Mission Bay Recruiting
San Francisco, California, United States, 94158
Contact: Site Public Contact    877-827-3222      
Principal Investigator: Kieuhoa T. Vo         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Site Public Contact    303-764-5056    josh.b.gordon@nsmtp.kp.org   
Principal Investigator: Margaret E. Macy         
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Recruiting
Denver, Colorado, United States, 80218
Contact: Site Public Contact    303-839-6000      
Principal Investigator: Jennifer J. Clark         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Site Public Contact    860-545-9981      
Principal Investigator: Michael S. Isakoff         
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Site Public Contact    203-785-5702    canceranswers@yale.edu   
Principal Investigator: Nina S. Kadan-Lottick         
United States, Delaware
Alfred I duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Site Public Contact    302-651-6884    dperry@nemours.org   
Principal Investigator: Ramamoorthy Nagasubramanian         
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Site Public Contact    202-884-2549      
Principal Investigator: Jeffrey S. Dome         
United States, Florida
Golisano Children's Hospital of Southwest Florida Recruiting
Fort Myers, Florida, United States, 33908
Contact: Site Public Contact    239-343-5333    molly.arnstrom@leehealth.org   
Principal Investigator: Emad K. Salman         
University of Florida Health Science Center - Gainesville Recruiting
Gainesville, Florida, United States, 32610
Contact: Site Public Contact    352-273-8010    cancer-center@ufl.edu   
Principal Investigator: William B. Slayton         
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Site Public Contact    954-265-1847    OHR@mhs.net   
Principal Investigator: Iftikhar Hanif         
Nemours Children's Clinic-Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Site Public Contact    904-697-3529      
Principal Investigator: Ramamoorthy Nagasubramanian         
University of Miami Miller School of Medicine-Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Site Public Contact    305-243-2647      
Principal Investigator: Julio C. Barredo         
Nicklaus Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Site Public Contact    888-624-2778      
Principal Investigator: Enrique A. Escalon         
AdventHealth Orlando Recruiting
Orlando, Florida, United States, 32803
Contact: Site Public Contact    407-303-2090    FH.Cancer.Research@flhosp.org   
Principal Investigator: Fouad M. Hajjar         
Nemours Children's Hospital Recruiting
Orlando, Florida, United States, 32827
Contact: Site Public Contact    407-650-7150      
Principal Investigator: Ramamoorthy Nagasubramanian         
Johns Hopkins All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Site Public Contact    727-767-4784    Ashley.Repp@jhmi.edu   
Principal Investigator: Nanette H. Grana         
Saint Mary's Hospital Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Site Public Contact    561-881-2815      
Principal Investigator: Narayana Gowda         
United States, Georgia
Children's Healthcare of Atlanta - Egleston Recruiting
Atlanta, Georgia, United States, 30322
Contact: Site Public Contact    404-785-2025    Leann.Schilling@choa.org   
Principal Investigator: William T. Cash         
Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31404
Contact: Site Public Contact    912-350-7887    clayter1@memorialhealth.com   
Principal Investigator: Andrew L. Pendleton         
United States, Hawaii
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Site Public Contact    808-983-6090      
Principal Investigator: Wade T. Kyono         
United States, Illinois
Lurie Children's Hospital-Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Site Public Contact    773-880-4562      
Principal Investigator: Jennifer L. Reichek         
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Site Public Contact    312-355-3046      
Principal Investigator: Mary L. Schmidt         
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Site Public Contact    773-702-8222    cancerclinicaltrials@bsd.uchicago.edu   
Principal Investigator: Susan L. Cohn         
Advocate Children's Hospital-Oak Lawn Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Site Public Contact    847-723-7570      
Principal Investigator: Rebecca E. McFall         
Advocate Children's Hospital-Park Ridge Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Rebecca E. McFall         
Saint Jude Midwest Affiliate Recruiting
Peoria, Illinois, United States, 61637
Contact: Site Public Contact    888-226-4343      
Principal Investigator: Jaime M. Libes         
Southern Illinois University School of Medicine Recruiting
Springfield, Illinois, United States, 62702
Contact: Site Public Contact    217-545-7929      
Principal Investigator: Gregory P. Brandt         
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Site Public Contact    800-248-1199      
Principal Investigator: Sandeep Batra         
United States, Iowa
Blank Children's Hospital Recruiting
Des Moines, Iowa, United States, 50309
Contact: Site Public Contact    515-241-8912    samantha.mallory@unitypoint.org   
Principal Investigator: Samantha L. Mallory         
University of Iowa/Holden Comprehensive Cancer Center Recruiting
Iowa City, Iowa, United States, 52242
Contact: Site Public Contact    800-237-1225      
Principal Investigator: Mariko Sato         
United States, Kentucky
University of Kentucky/Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Site Public Contact    859-257-3379      
Principal Investigator: Vlad C. Radulescu         
United States, Louisiana
Children's Hospital New Orleans Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Site Public Contact       CHResearch@lcmchealth.org   
Principal Investigator: Lolie C. Yu         
United States, Maine
Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Contact: Site Public Contact    207-973-4274      
Principal Investigator: Nadine P. SantaCruz         
Maine Children's Cancer Program Recruiting
Scarborough, Maine, United States, 04074
Contact: Site Public Contact    207-396-7581    sverwys@mmc.org   
Principal Investigator: Eric C. Larsen         
United States, Maryland
Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21215
Contact: Site Public Contact    410-601-6120    pridgely@lifebridgehealth.org   
Principal Investigator: Jason M. Fixler         
Johns Hopkins University/Sidney Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Site Public Contact    410-955-8804    jhcccro@jhmi.edu   
Principal Investigator: Allen R. Chen         
United States, Massachusetts
Floating Hospital for Children at Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Site Public Contact    617-636-5535      
Principal Investigator: Jason Law         
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Site Public Contact    877-726-5130      
Principal Investigator: Suzanne Shusterman         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Site Public Contact    877-442-3324      
Principal Investigator: Suzanne Shusterman         
United States, Michigan
C S Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Site Public Contact    800-865-1125      
Principal Investigator: Rajen Mody         
Wayne State University/Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Site Public Contact    313-576-9790    ctoadmin@karmanos.org   
Principal Investigator: Roland L. Chu         
Ascension Saint John Hospital Recruiting
Detroit, Michigan, United States, 48236
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Adonis N. Lorenzana         
Helen DeVos Children's Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Beaumont Children's Hospital-Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Site Public Contact    248-551-7695      
Principal Investigator: Laura K. Gowans         
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Site Public Contact    612-813-5193      
Principal Investigator: Michael K. Richards         
University of Minnesota/Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Site Public Contact    612-624-2620      
Principal Investigator: Emily G. Greengard         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Site Public Contact    855-776-0015      
Principal Investigator: Carola A. Arndt         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Site Public Contact    601-815-6700      
Principal Investigator: Anderson (Andy) B. Collier         
United States, Missouri
Columbia Regional Recruiting
Columbia, Missouri, United States, 65201
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Barbara A. Gruner         
Children's Mercy Hospitals and Clinics Recruiting
Kansas City, Missouri, United States, 64108
Contact: Site Public Contact    816-302-6808    rryan@cmh.edu   
Principal Investigator: Keith J. August         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Site Public Contact    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Shalini Shenoy         
Mercy Hospital Saint Louis Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Site Public Contact    314-251-7066      
Principal Investigator: Robin D. Hanson         
United States, Nebraska
Children's Hospital and Medical Center of Omaha Recruiting
Omaha, Nebraska, United States, 68114
Contact: Site Public Contact    402-955-3949      
Principal Investigator: Minnie Abromowitch         
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Site Public Contact    402-559-6941    unmcrsa@unmc.edu   
Principal Investigator: Minnie Abromowitch         
United States, Nevada
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Recruiting
Las Vegas, Nevada, United States, 89135
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: Alan K. Ikeda         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Site Public Contact    800-639-6918    cancer.research.nurse@dartmouth.edu   
Principal Investigator: Julie Kim         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Site Public Contact    201-996-2879      
Principal Investigator: Katharine Offer         
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Site Public Contact    973-971-5900      
Principal Investigator: John J. Gregory         
Saint Joseph's Regional Medical Center Recruiting
Paterson, New Jersey, United States, 07503
Contact: Site Public Contact    973-754-2207    HallL@sjhmc.org   
Principal Investigator: Alissa Kahn         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Site Public Contact    800-767-9355    askroswell@roswellpark.org   
Principal Investigator: Clare J. Twist         
NYU Winthrop Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Site Public Contact    516-663-3115      
Principal Investigator: Mark E. Weinblatt         
Laura and Isaac Perlmutter Cancer Center at NYU Langone Recruiting
New York, New York, United States, 10016
Contact: Site Public Contact    212-263-4434    prmc.coordinator@nyumc.org   
Principal Investigator: Sharon L. Gardner         
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center Recruiting
New York, New York, United States, 10032
Contact: Site Public Contact    212-305-6361    nr2616@cumc.columbia.edu   
Principal Investigator: Alice Lee         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Site Public Contact    585-275-5830      
Principal Investigator: Angela R. Girvin         
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Site Public Contact    914-594-3794      
Principal Investigator: Jessica C. Hochberg         
United States, North Carolina
Mission Hospital Inc-Memorial Campus Recruiting
Asheville, North Carolina, United States, 28801
Contact: Site Public Contact    828-213-4150    leslie.verner@msj.org   
Principal Investigator: Douglas J. Scothorn         
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Site Public Contact    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Stuart H. Gold         
Carolinas Medical Center/Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Site Public Contact    800-804-9376      
Principal Investigator: Joel A. Kaplan         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Site Public Contact    888-275-3853      
Principal Investigator: Jessica M. Sun         
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Site Public Contact    252-744-1015    eubankss@ecu.edu   
Principal Investigator: Andrea R. Whitfield         
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Site Public Contact    336-713-6771      
Principal Investigator: Thomas B. Russell         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Site Public Contact    513-636-2799    cancer@cchmc.org   
Principal Investigator: Brian D. Weiss         
Rainbow Babies and Childrens Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Site Public Contact    216-844-5437      
Principal Investigator: Duncan S. Stearns         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Site Public Contact    866-223-8100    CancerAnswer@ccf.org   
Principal Investigator: Rabi Hanna         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Site Public Contact    614-072-2657    amy.yekisa@nationwidechildrens.org   
Principal Investigator: Mark A. Ranalli         
Dayton Children's Hospital Recruiting
Dayton, Ohio, United States, 45404
Contact: Site Public Contact    800-228-4055      
Principal Investigator: Ayman A. El-Sheikh         
The Toledo Hospital/Toledo Children's Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Site Public Contact    419-824-1842      
Principal Investigator: Jamie L. Dargart         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Site Public Contact    405-271-8777    ou-clinical-trials@ouhsc.edu   
Principal Investigator: Rene Y. McNall-Knapp         
United States, Pennsylvania
Lehigh Valley Hospital-Cedar Crest Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Felipe S. Bautista-Otanez         
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Site Public Contact    570-271-5251    HemonCCTrials@geisinger.edu   
Principal Investigator: Jagadeesh Ramdas         
Penn State Children's Hospital Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Site Public Contact    717-531-6012      
Principal Investigator: Lisa M. McGregor         
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Site Public Contact    267-425-5544    CancerTrials@email.chop.edu   
Principal Investigator: Rochelle Bagatell         
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Site Public Contact    412-692-8570    jean.tersak@chp.edu   
Principal Investigator: Jean M. Tersak         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Site Public Contact    401-444-1488      
Principal Investigator: Jennifer J. Greene Welch         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Site Public Contact    843-792-9321    hcc-clinical-trials@musc.edu   
Principal Investigator: Jacqueline M. Kraveka         
Prisma Health Richland Hospital Recruiting
Columbia, South Carolina, United States, 29203
Contact: Site Public Contact    803-434-3533      
Principal Investigator: Stuart L. Cramer         
BI-LO Charities Children's Cancer Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Site Public Contact    864-455-8898      
Principal Investigator: Nichole L. Bryant         
United States, South Dakota
Sanford USD Medical Center - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contact: Site Public Contact    605-312-3320    OncologyClinicalTrialsSF@SanfordHealth.org   
Principal Investigator: Kayelyn J. Wagner         
United States, Tennessee
East Tennessee Childrens Hospital Recruiting
Knoxville, Tennessee, United States, 37916
Contact: Site Public Contact    865-541-8266      
Principal Investigator: Ray C. Pais         
Vanderbilt University/Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Site Public Contact    800-811-8480      
Principal Investigator: Carrie L. Kitko         
United States, Texas
Dell Children's Medical Center of Central Texas Suspended
Austin, Texas, United States, 78723
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: Site Public Contact    361-694-5311    Crystal.DeLosSantos@dchstx.org   
Principal Investigator: Nkechi I. Mba         
Medical City Dallas Hospital Recruiting
Dallas, Texas, United States, 75230
Contact: Site Public Contact    972-566-5588      
Principal Investigator: Stanton C. Goldman         
UT Southwestern/Simmons Cancer Center-Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Site Public Contact    214-648-7097    canceranswerline@UTSouthwestern.edu   
Principal Investigator: Tanya C. Watt         
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Site Public Contact    682-885-2103    CookChildrensResearch@cookchildrens.org   
Principal Investigator: Mary Meaghan P. Granger         
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Site Public Contact    713-798-1354    burton@bcm.edu   
Principal Investigator: Jennifer H. Foster         
Children's Hospital of San Antonio Recruiting
San Antonio, Texas, United States, 78207
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Timothy C. Griffin         
Methodist Children's Hospital of South Texas Recruiting
San Antonio, Texas, United States, 78229
Contact: Site Public Contact    210-575-6240    Vinod.GidvaniDiaz@hcahealthcare.com   
Principal Investigator: Vinod K. Gidvani-Diaz         
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Site Public Contact    210-450-3800    phoresearchoffice@uthscsa.edu   
Principal Investigator: Anne-Marie R. Langevin         
United States, Vermont
University of Vermont and State Agricultural College Recruiting
Burlington, Vermont, United States, 05405
Contact: Site Public Contact    802-656-8990    rpo@uvm.edu   
Principal Investigator: Jessica L. Heath         
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Site Public Contact    804-628-1939    mwellons@vcu.edu   
Principal Investigator: Madhu S. Gowda         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Site Public Contact    866-987-2000      
Principal Investigator: Douglas S. Hawkins         
Providence Sacred Heart Medical Center and Children's Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Site Public Contact    800-228-6618    HopeBeginsHere@providence.org   
Principal Investigator: Judy L. Felgenhauer         
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Contact: Site Public Contact    253-968-0129    mamcdci@amedd.army.mil   
Principal Investigator: Melissa A. Forouhar         
United States, West Virginia
West Virginia University Healthcare Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Site Public Contact    304-293-7374    cancertrialsinfo@hsc.wvu.edu   
Principal Investigator: Stephan R. Paul         
United States, Wisconsin
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Site Public Contact    800-622-8922      
Principal Investigator: Kenneth B. DeSantes         
Marshfield Medical Center-Marshfield Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Michelle A. Manalang         
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Site Public Contact    414-955-4727    MACCCTO@mcw.edu   
Principal Investigator: Meghen B. Browning         
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Site Public Contact    866-561-1026    ctu_web@cancercare.mb.ca   
Principal Investigator: Tanya R. Brown         
Canada, Newfoundland and Labrador
Janeway Child Health Centre Recruiting
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Contact: Site Public Contact    866-722-1126      
Principal Investigator: Lisa A. Goodyear         
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Site Public Contact    902-470-6767      
Principal Investigator: Conrad V. Fernandez         
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Site Public Contact    905-521-2100      
Principal Investigator: Uma H. Athale         
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Site Public Contact    613-738-3931      
Principal Investigator: Donna L. Johnston         
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Site Public Contact    416-813-7654 ext 2027    jason.mcguire@sickkids.ca   
Principal Investigator: Daniel A. Morgenstern         
Puerto Rico
HIMA San Pablo Oncologic Hospital Recruiting
Caguas, Puerto Rico, 00726
Contact: Site Public Contact    787-653-3434      
Principal Investigator: Jhon A. Guerra         
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Rochelle Bagatell Children's Oncology Group

Layout table for additonal information
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT03126916     History of Changes
Other Study ID Numbers: ANBL1531
NCI-2016-01734 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ANBL1531 ( Other Identifier: Childrens Oncology Group )
ANBL1531 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroblastoma
Ganglioneuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Aldesleukin
Cisplatin
Cyclophosphamide
Carboplatin
Doxorubicin
Liposomal doxorubicin
Etoposide
Vincristine
Melphalan
Busulfan
Topotecan
Interleukin-2
Crizotinib
Thiotepa
Tretinoin
Mechlorethamine
3-Iodobenzylguanidine
Dexrazoxane
Razoxane