Purpose

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 compared to crizotinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma.

Category

IRB Number
20180742HU
NCT Number
NCT03126916
Open to Enrollment
Yes
Sponsor
Children's Oncology Group -



Study Contact

Virginia Diaz
(210) 562-9149
diazvr@uthscsa.edu

Jaclyn Hung
+1 (210) 450-5358
hungj@uthscsa.edu

Principal Investigator
Anne-Marie Langevin

Virginia Diaz
(210) 562-9149
diazvr@uthscsa.edu

Jaclyn Hung
+1 (210) 450-5358
hungj@uthscsa.edu

Anne-Marie Langevin
(210) 567-7460
langevin@uthscsa.edu



Eligibility

Eligible Ages
Between 365 Days and 30 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 3
      Study Type
      Interventional
      Allocation
      Randomized
      Intervention Model
      Parallel Assignment
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. Ganglioneuroblastoma
    2. INRG Stage L2
    3. INRG Stage M
    4. INRG Stage MS
    5. Neuroblastoma
    6. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Arm A (chemotherapy, HSCT, EBRT)

      See Arm A in detailed description.
    7. Procedure: Autologous Hematopoietic Stem Cell Transplantation

      Undergo autologous HSCT

      Other names:

      • AHSCT
      • Autologous
      • Autologous Hematopoietic Cell Transplantation
      • Autologous Stem Cell Transplant
      • Autologous Stem Cell Transplantation
      • Stem Cell Transplantation, Autologous

    8. Drug: Carboplatin

      Given IV

      Other names:

      • Blastocarb
      • Carboplat
      • Carboplatin Hexal
      • Carboplatino
      • Carboplatinum
      • Carbosin
      • Carbosol
      • Carbotec
      • CBDCA
      • Displata
      • Ercar
      • JM-8
      • Nealorin
      • Nov

    9. Drug: Dexrazoxane Hydrochloride

      Given IV

      Other names:

      • Cardioxane
      • Totect
      • Zinecard

    10. 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

      • Radiation: External Beam Radiation Therapy

        Undergo EBRT

        Other names:

        • Definitive Radiation Therapy
        • EBRT
        • External Beam Radiation
        • External Beam Radiotherapy
        • External Beam RT
        • external radiation
        • External Radiation Therapy
        • external-beam

      • 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
        • Cista

      • Biological: Sargramostim

        Given SC

        Other names:

        • 23-L-Leucinecolony-Stimulating Factor 2
        • DRG-0012
        • Leukine
        • Prokine
        • rhu GM-CFS
        • Sagramostim
        • Sargramostatin

      • Drug: Thiotepa

        Given IV

        Other names:

        • 1,1'',1''''-Phosphinothioylidynetrisaziridine
        • Girostan
        • N,N'', N''''-Triethylenethiophosphoramide
        • Oncotiotepa
        • STEPA
        • Tepadina
        • TESPA
        • Tespamin
        • Tespamine
        • Th

      • Drug: Vincristine Sulfate

        Given IV

        Other names:

        • Kyocristine
        • Leurocristine Sulfate
        • Leurocristine, sulfate
        • Oncovin
        • Vincasar
        • Vincosid
        • Vincrex
        • Vincristine, sulfate

      • Drug: Cisplatin

        Given IV

        Other names:

        • Abiplatin
        • Blastolem
        • Briplatin
        • CDDP
        • Cis-diammine-dichloroplatinum
        • Cis-diamminedichloridoplatinum
        • Cis-diamminedichloro Platinum (II)
        • Cis-diamminedichloroplatinum

      • 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 <

      • Biological: Dinutuximab

        Given IV

        Other names:

        • Ch 14.18UTC
        • Ch14.18
        • MOAB Ch14.18
        • monoclonal antibody Ch14.18
        • Unituxin

      • Drug: Etoposide Phosphate

        Given IV

        Other names:

        • Etopophos

      • Procedure: Therapeutic Conventional Surgery

        Undergo standard of care surgery

      • Drug: Topotecan Hydrochloride

        Given IV

        Other names:

        • Hycamptamine
        • Hycamtin
        • SKF S-104864-A
        • Topotecan HCl
        • topotecan hydrochloride (oral)

    11. Experimental

      Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)

      See Arm C in detailed description. Closed to accrual as of 12/17/20.
    12. Procedure: Autologous Hematopoietic Stem Cell Transplantation

      Undergo autologous HSCT

      Other names:

      • AHSCT
      • Autologous
      • Autologous Hematopoietic Cell Transplantation
      • Autologous Stem Cell Transplant
      • Autologous Stem Cell Transplantation
      • Stem Cell Transplantation, Autologous

    13. Drug: Dexrazoxane Hydrochloride

      Given IV

      Other names:

      • Cardioxane
      • Totect
      • Zinecard

    14. 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

      • Radiation: External Beam Radiation Therapy

        Undergo EBRT

        Other names:

        • Definitive Radiation Therapy
        • EBRT
        • External Beam Radiation
        • External Beam Radiotherapy
        • External Beam RT
        • external radiation
        • External Radiation Therapy
        • external-beam

      • 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
        • Cista

      • Biological: Sargramostim

        Given SC

        Other names:

        • 23-L-Leucinecolony-Stimulating Factor 2
        • DRG-0012
        • Leukine
        • Prokine
        • rhu GM-CFS
        • Sagramostim
        • Sargramostatin

      • Drug: Thiotepa

        Given IV

        Other names:

        • 1,1'',1''''-Phosphinothioylidynetrisaziridine
        • Girostan
        • N,N'', N''''-Triethylenethiophosphoramide
        • Oncotiotepa
        • STEPA
        • Tepadina
        • TESPA
        • Tespamin
        • Tespamine
        • Th

      • Drug: Vincristine Sulfate

        Given IV

        Other names:

        • Kyocristine
        • Leurocristine Sulfate
        • Leurocristine, sulfate
        • Oncovin
        • Vincasar
        • Vincosid
        • Vincrex
        • Vincristine, sulfate

      • 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
        • Methanesul

      • Drug: Cisplatin

        Given IV

        Other names:

        • Abiplatin
        • Blastolem
        • Briplatin
        • CDDP
        • Cis-diammine-dichloroplatinum
        • Cis-diamminedichloridoplatinum
        • Cis-diamminedichloro Platinum (II)
        • Cis-diamminedichloroplatinum

      • 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 <

      • Biological: Dinutuximab

        Given IV

        Other names:

        • Ch 14.18UTC
        • Ch14.18
        • MOAB Ch14.18
        • monoclonal antibody Ch14.18
        • Unituxin

      • Drug: Etoposide Phosphate

        Given IV

        Other names:

        • Etopophos

      • Radiation: Iobenguane I-131

        Given IV

        Other names:

        • (131)I-MIBG
        • 131I-MIBG
        • I 131 Meta-iodobenzylguanidine
        • I-131 Metaiodobenzylguanidine
        • Iobenguane (131I)
        • Iobenguane I 131
        • Iodine I 131 Metaiodobenzylguanidine
        • MIBG I

      • Drug: Melphalan Hydrochloride

        Given IV

        Other names:

        • Alkeran
        • Alkerana
        • Evomela

      • Procedure: Therapeutic Conventional Surgery

        Undergo standard of care surgery

      • Drug: Topotecan Hydrochloride

        Given IV

        Other names:

        • Hycamptamine
        • Hycamtin
        • SKF S-104864-A
        • Topotecan HCl
        • topotecan hydrochloride (oral)

    15. Experimental

      Arm E (crizotinib, chemotherapy, HSCT, EBRT)

      See Arm E in detailed description.
    16. Procedure: Autologous Hematopoietic Stem Cell Transplantation

      Undergo autologous HSCT

      Other names:

      • AHSCT
      • Autologous
      • Autologous Hematopoietic Cell Transplantation
      • Autologous Stem Cell Transplant
      • Autologous Stem Cell Transplantation
      • Stem Cell Transplantation, Autologous

    17. Drug: Carboplatin

      Given IV

      Other names:

      • Blastocarb
      • Carboplat
      • Carboplatin Hexal
      • Carboplatino
      • Carboplatinum
      • Carbosin
      • Carbosol
      • Carbotec
      • CBDCA
      • Displata
      • Ercar
      • JM-8
      • Nealorin
      • Nov

    18. Drug: Crizotinib

      Given PO

      Other names:

      • MET Tyrosine Kinase Inhibitor PF-02341066
      • PF-02341066
      • PF-2341066
      • Xalkori

    19. Drug: Dexrazoxane Hydrochloride

      Given IV

      Other names:

      • Cardioxane
      • Totect
      • Zinecard

    20. 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

      • Radiation: External Beam Radiation Therapy

        Undergo EBRT

        Other names:

        • Definitive Radiation Therapy
        • EBRT
        • External Beam Radiation
        • External Beam Radiotherapy
        • External Beam RT
        • external radiation
        • External Radiation Therapy
        • external-beam

      • 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
        • Cista

      • Biological: Sargramostim

        Given SC

        Other names:

        • 23-L-Leucinecolony-Stimulating Factor 2
        • DRG-0012
        • Leukine
        • Prokine
        • rhu GM-CFS
        • Sagramostim
        • Sargramostatin

      • Drug: Thiotepa

        Given IV

        Other names:

        • 1,1'',1''''-Phosphinothioylidynetrisaziridine
        • Girostan
        • N,N'', N''''-Triethylenethiophosphoramide
        • Oncotiotepa
        • STEPA
        • Tepadina
        • TESPA
        • Tespamin
        • Tespamine
        • Th

      • Drug: Cisplatin

        Given IV

        Other names:

        • Abiplatin
        • Blastolem
        • Briplatin
        • CDDP
        • Cis-diammine-dichloroplatinum
        • Cis-diamminedichloridoplatinum
        • Cis-diamminedichloro Platinum (II)
        • Cis-diamminedichloroplatinum

      • 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 <

      • Biological: Dinutuximab

        Given IV

        Other names:

        • Ch 14.18UTC
        • Ch14.18
        • MOAB Ch14.18
        • monoclonal antibody Ch14.18
        • Unituxin

      • Drug: Etoposide Phosphate

        Given IV

        Other names:

        • Etopophos

      • Procedure: Therapeutic Conventional Surgery

        Undergo standard of care surgery

      • Drug: Topotecan Hydrochloride

        Given IV

        Other names:

        • Hycamptamine
        • Hycamtin
        • SKF S-104864-A
        • Topotecan HCl
        • topotecan hydrochloride (oral)

    21. Experimental

      Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)

      See Arm B in detailed description.
    22. Procedure: Autologous Hematopoietic Stem Cell Transplantation

      Undergo autologous HSCT

      Other names:

      • AHSCT
      • Autologous
      • Autologous Hematopoietic Cell Transplantation
      • Autologous Stem Cell Transplant
      • Autologous Stem Cell Transplantation
      • Stem Cell Transplantation, Autologous

    23. Drug: Carboplatin

      Given IV

      Other names:

      • Blastocarb
      • Carboplat
      • Carboplatin Hexal
      • Carboplatino
      • Carboplatinum
      • Carbosin
      • Carbosol
      • Carbotec
      • CBDCA
      • Displata
      • Ercar
      • JM-8
      • Nealorin
      • Nov

    24. Drug: Dexrazoxane Hydrochloride

      Given IV

      Other names:

      • Cardioxane
      • Totect
      • Zinecard

    25. 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

      • Radiation: External Beam Radiation Therapy

        Undergo EBRT

        Other names:

        • Definitive Radiation Therapy
        • EBRT
        • External Beam Radiation
        • External Beam Radiotherapy
        • External Beam RT
        • external radiation
        • External Radiation Therapy
        • external-beam

      • 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
        • Cista

      • Biological: Sargramostim

        Given SC

        Other names:

        • 23-L-Leucinecolony-Stimulating Factor 2
        • DRG-0012
        • Leukine
        • Prokine
        • rhu GM-CFS
        • Sagramostim
        • Sargramostatin

      • Drug: Thiotepa

        Given IV

        Other names:

        • 1,1'',1''''-Phosphinothioylidynetrisaziridine
        • Girostan
        • N,N'', N''''-Triethylenethiophosphoramide
        • Oncotiotepa
        • STEPA
        • Tepadina
        • TESPA
        • Tespamin
        • Tespamine
        • Th

      • Drug: Vincristine Sulfate

        Given IV

        Other names:

        • Kyocristine
        • Leurocristine Sulfate
        • Leurocristine, sulfate
        • Oncovin
        • Vincasar
        • Vincosid
        • Vincrex
        • Vincristine, sulfate

      • Drug: Cisplatin

        Given IV

        Other names:

        • Abiplatin
        • Blastolem
        • Briplatin
        • CDDP
        • Cis-diammine-dichloroplatinum
        • Cis-diamminedichloridoplatinum
        • Cis-diamminedichloro Platinum (II)
        • Cis-diamminedichloroplatinum

      • 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 <

      • Biological: Dinutuximab

        Given IV

        Other names:

        • Ch 14.18UTC
        • Ch14.18
        • MOAB Ch14.18
        • monoclonal antibody Ch14.18
        • Unituxin

      • Drug: Etoposide Phosphate

        Given IV

        Other names:

        • Etopophos

      • Radiation: Iobenguane I-131

        Given IV

        Other names:

        • (131)I-MIBG
        • 131I-MIBG
        • I 131 Meta-iodobenzylguanidine
        • I-131 Metaiodobenzylguanidine
        • Iobenguane (131I)
        • Iobenguane I 131
        • Iodine I 131 Metaiodobenzylguanidine
        • MIBG I

      • Procedure: Therapeutic Conventional Surgery

        Undergo standard of care surgery

      • Drug: Topotecan Hydrochloride

        Given IV

        Other names:

        • Hycamptamine
        • Hycamtin
        • SKF S-104864-A
        • Topotecan HCl
        • topotecan hydrochloride (oral)

    26. Experimental

      Arm D (chemotherapy, HSCT, EBRT)

      See Arm D in detailed description.
    27. Procedure: Autologous Hematopoietic Stem Cell Transplantation

      Undergo autologous HSCT

      Other names:

      • AHSCT
      • Autologous
      • Autologous Hematopoietic Cell Transplantation
      • Autologous Stem Cell Transplant
      • Autologous Stem Cell Transplantation
      • Stem Cell Transplantation, Autologous

    28. Drug: Carboplatin

      Given IV

      Other names:

      • Blastocarb
      • Carboplat
      • Carboplatin Hexal
      • Carboplatino
      • Carboplatinum
      • Carbosin
      • Carbosol
      • Carbotec
      • CBDCA
      • Displata
      • Ercar
      • JM-8
      • Nealorin
      • Nov

    29. Drug: Dexrazoxane Hydrochloride

      Given IV

      Other names:

      • Cardioxane
      • Totect
      • Zinecard

    30. 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

      • Radiation: External Beam Radiation Therapy

        Undergo EBRT

        Other names:

        • Definitive Radiation Therapy
        • EBRT
        • External Beam Radiation
        • External Beam Radiotherapy
        • External Beam RT
        • external radiation
        • External Radiation Therapy
        • external-beam

      • 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
        • Cista

      • Biological: Sargramostim

        Given SC

        Other names:

        • 23-L-Leucinecolony-Stimulating Factor 2
        • DRG-0012
        • Leukine
        • Prokine
        • rhu GM-CFS
        • Sagramostim
        • Sargramostatin

      • Drug: Thiotepa

        Given IV

        Other names:

        • 1,1'',1''''-Phosphinothioylidynetrisaziridine
        • Girostan
        • N,N'', N''''-Triethylenethiophosphoramide
        • Oncotiotepa
        • STEPA
        • Tepadina
        • TESPA
        • Tespamin
        • Tespamine
        • Th

      • Drug: Vincristine Sulfate

        Given IV

        Other names:

        • Kyocristine
        • Leurocristine Sulfate
        • Leurocristine, sulfate
        • Oncovin
        • Vincasar
        • Vincosid
        • Vincrex
        • Vincristine, sulfate

      • Drug: Cisplatin

        Given IV

        Other names:

        • Abiplatin
        • Blastolem
        • Briplatin
        • CDDP
        • Cis-diammine-dichloroplatinum
        • Cis-diamminedichloridoplatinum
        • Cis-diamminedichloro Platinum (II)
        • Cis-diamminedichloroplatinum

      • 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 <

      • Biological: Dinutuximab

        Given IV

        Other names:

        • Ch 14.18UTC
        • Ch14.18
        • MOAB Ch14.18
        • monoclonal antibody Ch14.18
        • Unituxin

      • Drug: Etoposide Phosphate

        Given IV

        Other names:

        • Etopophos

      • Procedure: Therapeutic Conventional Surgery

        Undergo standard of care surgery

      • Drug: Topotecan Hydrochloride

        Given IV

        Other names:

        • Hycamptamine
        • Hycamtin
        • SKF S-104864-A
        • Topotecan HCl
        • topotecan hydrochloride (oral)