Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)

NCT03126916 | Recruiting Phase 3 FDA Drug

• 3 other identifiers: ANBL1531NCI-2016-01734U10CA180886
• Study Type: interventional
• Target: 750
• Locations: 3 countries
• Sites: 162

Brief Summary

This phase III trial studies iobenguane I-131 or lorlatinib 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. Lorlatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or lorlatinib and standard therapy may work better compared to lorlatinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma.

Conditions

Ganglioneuroblastoma; Ganglioneuroblastoma, Nodular; Neuroblastoma

Outcome Measures

Primary Outcomes (1)

• Event free survival (EFS) (Arm A, B, D, and E)

  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.

  3 years

Secondary Outcomes (4)

• Incidence of adverse events

  Up to 18 months for Arms A-D and 28 months for Arm E

• EFS (Arm C)

  3 years

• Overall survival (OS)

  3 years

• Response rate

  Up to 6 months

Study Arms (5)

Arm A (chemotherapy, HSCT, EBRT)

EXPERIMENTAL

See Arm A in detailed description.

Procedure: Autologous Hematopoietic Stem Cell Transplantation; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration and Biopsy; Drug: Carboplatin; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Cyclophosphamide; Drug: Dexrazoxane Hydrochloride; Biological: Dinutuximab; Drug: Doxorubicin Hydrochloride; Procedure: Echocardiography Test; Drug: Etoposide Phosphate; Radiation: External Beam Radiation Therapy; Radiation: Iobenguane I-123; Drug: Isotretinoin; Procedure: Multigated Acquisition Scan; Procedure: Positron Emission Tomography; Biological: Sargramostim; Procedure: Therapeutic Conventional Surgery; Drug: Thiotepa; Drug: Topotecan Hydrochloride; Drug: Vincristine Sulfate

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

EXPERIMENTAL

See Arm B in detailed description.

Procedure: Autologous Hematopoietic Stem Cell Transplantation; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration and Biopsy; Drug: Carboplatin; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Cyclophosphamide; Drug: Dexrazoxane Hydrochloride; Biological: Dinutuximab; Drug: Doxorubicin Hydrochloride; Procedure: Echocardiography Test; Drug: Etoposide Phosphate; Radiation: External Beam Radiation Therapy; Radiation: Iobenguane I-123; Radiation: Iobenguane I-131; Drug: Isotretinoin; Procedure: Magnetic Resonance Imaging; Procedure: Multigated Acquisition Scan; Procedure: Positron Emission Tomography; Biological: Sargramostim; Procedure: Therapeutic Conventional Surgery; Drug: Thiotepa; Drug: Topotecan Hydrochloride; Drug: Vincristine Sulfate

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

EXPERIMENTAL

See Arm C in detailed description. Closed to accrual as of 12/17/20.

Procedure: Autologous Hematopoietic Stem Cell Transplantation; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration and Biopsy; Drug: Busulfan; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Cyclophosphamide; Drug: Dexrazoxane Hydrochloride; Biological: Dinutuximab; Drug: Doxorubicin Hydrochloride; Procedure: Echocardiography Test; Drug: Etoposide Phosphate; Radiation: External Beam Radiation Therapy; Radiation: Iobenguane I-131; Drug: Isotretinoin; Procedure: Magnetic Resonance Imaging; Drug: Melphalan Hydrochloride; Procedure: Multigated Acquisition Scan; Procedure: Positron Emission Tomography; Biological: Sargramostim; Procedure: Therapeutic Conventional Surgery; Drug: Thiotepa; Drug: Topotecan Hydrochloride; Drug: Vincristine Sulfate

Arm D (chemotherapy, HSCT, EBRT)

EXPERIMENTAL

See Arm D in detailed description.

Procedure: Autologous Hematopoietic Stem Cell Transplantation; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration and Biopsy; Drug: Carboplatin; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Cyclophosphamide; Drug: Dexrazoxane Hydrochloride; Biological: Dinutuximab; Drug: Doxorubicin Hydrochloride; Drug: Etoposide Phosphate; Radiation: External Beam Radiation Therapy; Radiation: Iobenguane I-123; Drug: Isotretinoin; Procedure: Magnetic Resonance Imaging; Procedure: Multigated Acquisition Scan; Procedure: Positron Emission Tomography; Biological: Sargramostim; Procedure: Therapeutic Conventional Surgery; Drug: Thiotepa; Drug: Topotecan Hydrochloride; Drug: Vincristine Sulfate

Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

EXPERIMENTAL

See Arm E in detailed description.

Procedure: Autologous Hematopoietic Stem Cell Transplantation; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration and Biopsy; Drug: Carboplatin; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Cyclophosphamide; Drug: Dexrazoxane Hydrochloride; Biological: Dinutuximab; Drug: Doxorubicin Hydrochloride; Procedure: Echocardiography Test; Drug: Etoposide Phosphate; Radiation: External Beam Radiation Therapy; Radiation: Iobenguane I-123; Drug: Isotretinoin; Drug: Lorlatinib; Procedure: Multigated Acquisition Scan; Procedure: Positron Emission Tomography; Biological: Sargramostim; Procedure: Therapeutic Conventional Surgery; Drug: Thiotepa; Drug: Topotecan Hydrochloride

Interventions

Computed Tomography PROCEDURE

Undergo CT scan

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Arm A (chemotherapy, HSCT, EBRT); Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT); Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT); Arm D (chemotherapy, HSCT, EBRT); Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

Cyclophosphamide DRUG

Given IV

Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518, B-518, B518, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR 138719, WR- 138719, WR-138719, WR138719

Arm A (chemotherapy, HSCT, EBRT); Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT); Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT); Arm D (chemotherapy, HSCT, EBRT); Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

Dexrazoxane Hydrochloride DRUG

Given IV

Also known as: Cardioxane, Totect, Zinecard

Arm A (chemotherapy, HSCT, EBRT); Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT); Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT); Arm D (chemotherapy, HSCT, EBRT); Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

Dinutuximab BIOLOGICAL

Given IV

Also known as: Ch 14.18UTC, Ch14.18, Dinutuximab Beta, MOAB Ch14.18, monoclonal antibody Ch14.18, Qarziba, Unituxin

Arm A (chemotherapy, HSCT, EBRT); Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT); Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT); Arm D (chemotherapy, HSCT, EBRT); Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

Echocardiography Test PROCEDURE

Undergo echocardiography

Also known as: EC, Echocardiography

Arm A (chemotherapy, HSCT, EBRT); Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT); Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT); Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

Etoposide Phosphate DRUG

Given IV

Also known as: Etopophos

Arm A (chemotherapy, HSCT, EBRT); Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT); Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT); Arm D (chemotherapy, HSCT, EBRT); Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

External Beam Radiation Therapy RADIATION

Undergo EBRT

Also known as: Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy, External Beam Radiotherapy (conventional), External Beam RT, external radiation, External Radiation Therapy, external-beam radiation, Radiation, External Beam, Teleradiotherapy, Teletherapy, Teletherapy Radiation

Arm A (chemotherapy, HSCT, EBRT); Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT); Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT); Arm D (chemotherapy, HSCT, EBRT); Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

Therapeutic Conventional Surgery PROCEDURE

Undergo standard of care surgery

Arm A (chemotherapy, HSCT, EBRT); Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT); Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT); Arm D (chemotherapy, HSCT, EBRT); Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

Thiotepa DRUG

Given IV

Also known as: 1,1',1''-Phosphinothioylidynetrisaziridine, Girostan, N,N', N''-Triethylenethiophosphoramide, Oncotiotepa, SH 105, SH-105, SH105, STEPA, Tepadina, Tepylute, TESPA, Tespamin, Tespamine, Thio-Tepa, Thiofosfamide, Thiofozil, Thiophosphamide, Thiophosphoamide, Thiophosphoramide, Thiotef, Tifosyl, TIO TEF, Tio-tef, Triethylene Thiophosphoramide, Triethylenethiophosphoramide, Tris(1-aziridinyl)phosphine sulfide, TSPA, WR 45312

Arm A (chemotherapy, HSCT, EBRT); Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT); Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT); Arm D (chemotherapy, HSCT, EBRT); Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

Autologous Hematopoietic Stem Cell Transplantation PROCEDURE

Undergo autologous HSCT

Also known as: AHSCT, Autologous, Autologous Hematopoietic Cell Transplantation, Autologous Stem Cell Transplant, Autologous Stem Cell Transplantation, Stem Cell Transplantation, Autologous

Arm A (chemotherapy, HSCT, EBRT); Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT); Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT); Arm D (chemotherapy, HSCT, EBRT); Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm A (chemotherapy, HSCT, EBRT); Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT); Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT); Arm D (chemotherapy, HSCT, EBRT); Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

Bone Marrow Aspiration and Biopsy PROCEDURE

Undergo bone marrow aspiration and biopsy

Arm A (chemotherapy, HSCT, EBRT); Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT); Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT); Arm D (chemotherapy, HSCT, EBRT); Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

Busulfan DRUG

Given IV

Also known as: 1, 4-Bis[methanesulfonoxy]butane, BUS, Busilvex, 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

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

Carboplatin DRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Arm A (chemotherapy, HSCT, EBRT); Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT); Arm D (chemotherapy, HSCT, EBRT); Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

Cisplatin DRUG

Given IV

Also known as: 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

Arm A (chemotherapy, HSCT, EBRT); Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT); Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT); Arm D (chemotherapy, HSCT, EBRT); Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

Doxorubicin Hydrochloride DRUG

Given IV

Also known as: 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, FI106, hydroxydaunorubicin, Rubex

Arm A (chemotherapy, HSCT, EBRT); Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT); Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT); Arm D (chemotherapy, HSCT, EBRT); Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

Iobenguane I-123 RADIATION

Given 123 I-MIBG

Also known as: 123I-Metaiodobenzylguanidine, 123I-MIBG, AdreView, I-123-MIBG, Iobenguane (123 I), Iobenguane I 123, Iodine I 123-Metaiodobenzylguanidine, MIBG I-123

Arm A (chemotherapy, HSCT, EBRT); Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT); Arm D (chemotherapy, HSCT, EBRT); Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

Iobenguane I-131 RADIATION

Given IV

Also known as: (131)I-MIBG, 131I-MIBG, I 131 Meta-iodobenzylguanidine, I-131 Metaiodobenzylguanidine, Iobenguane (131I), Iobenguane I 131, Iodine I 131 Metaiodobenzylguanidine, MIBG I-131, Raiatt MIBG-I 131

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

Isotretinoin DRUG

Given PO

Also known as: 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

Arm A (chemotherapy, HSCT, EBRT); Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT); Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT); Arm D (chemotherapy, HSCT, EBRT); Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

Lorlatinib DRUG

Given PO

Also known as: 2H-4,8-Methenopyrazolo(4,3-H)(2,5,11)benzoxadiazacyclotetradecine-3-carbonitrile, 7-amino-12-fluoro-10,15,16,17-tetrahydro-2,10,16-trimethyl-15-oxo-, (10R)-, Lorbrena, Lorviqua, PF 06463922, PF-06463922, PF06463922

Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

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

Melphalan Hydrochloride DRUG

Given IV

Also known as: Alkeran, Alkerana, Evomela, Hepzato

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

Multigated Acquisition Scan PROCEDURE

Undergo MUGA scan

Also known as: Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNV Scan, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning

Arm A (chemotherapy, HSCT, EBRT); Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT); Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT); Arm D (chemotherapy, HSCT, EBRT); Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

Positron Emission Tomography PROCEDURE

Undergo PET scan

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Arm A (chemotherapy, HSCT, EBRT); Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT); Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT); Arm D (chemotherapy, HSCT, EBRT); Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

Sargramostim BIOLOGICAL

Given SC

Also known as: 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine, rhu GM-CFS, Sagramostim, Sargramostatin

Arm A (chemotherapy, HSCT, EBRT); Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT); Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT); Arm D (chemotherapy, HSCT, EBRT); Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

Topotecan Hydrochloride DRUG

Given IV

Also known as: Evotopin, Hycamptamine, Hycamtin, Nogitecan Hydrochloride, Potactasol, SKF S 104864 A, SKF S-104864-A, SKF S104864A, Topotec, Topotecan HCl, topotecan hydrochloride (oral)

Arm A (chemotherapy, HSCT, EBRT); Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT); Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT); Arm D (chemotherapy, HSCT, EBRT); Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

Vincristine Sulfate DRUG

Given IV

Also known as: Kyocristine, Leurocristine Sulfate, Leurocristine, sulfate, Oncovin, Vincasar, Vincosid, Vincrex, Vincristine, sulfate

Arm A (chemotherapy, HSCT, EBRT); Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT); Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT); Arm D (chemotherapy, HSCT, EBRT)

Eligibility Criteria

• Age: 365 Days - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients must be enrolled on ANBL00B1 (NCT00904241) or APEC14B1 (NCT02402244) prior to enrollment on ANBL1531 (NCT03126916)
• FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patient must be \>= 365 days and =\< 30 years of age at diagnosis
• FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: 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
• FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: 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
• FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: 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:
• to \< 2 years: male = 0.6; female = 0.6
• to \< 6 years: male = 0.8; female = 0.8
• to \< 10 years: male = 1; female = 1

You may not qualify if:

• FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients with INRG stage L2 tumors without amplification of MYCN regardless of tumor histology (may meet criteria for high risk classification but are not eligible for this trial)
• FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients with bone marrow failure syndromes
• FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients for whom targeted radiopharmaceutical therapy would be contraindicated due to underlying medical disorders
• FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: 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
• FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Lactating females who plan to breastfeed their infants
• FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
• PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients who have previously received treatment with lorlatinib or other ALK inhibitor
• PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients who have undergone treatment arm randomization callback or started induction cycle 2 on ANBL2131 (NCT06172296)
• PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients who have an INRG Stage L2 tumor without amplification of MYCN regardless of tumor histology (may meet criteria for high risk classification but are not eligible for this trial)
• PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients with bone marrow failure syndromes
• PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): 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
• PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Lactating females who plan to breastfeed their infants
• PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (162)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

RECRUITING

Phoenix Childrens Hospital

Phoenix, Arizona, 85016, United States

RECRUITING

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591, United States

RECRUITING

Kaiser Permanente Downey Medical Center

Downey, California, 90242, United States

RECRUITING

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

RECRUITING

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

Mattel Children's Hospital UCLA

Los Angeles, California, 90095, United States

RECRUITING

Valley Children's Hospital

Madera, California, 93636, United States

RECRUITING

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

RECRUITING

Children's Hospital of Orange County

Orange, California, 92868, United States

RECRUITING

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, 94304, United States

RECRUITING

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

RECRUITING

Rady Children's Hospital - San Diego

San Diego, California, 92123, United States

RECRUITING

Naval Medical Center -San Diego

San Diego, California, 92134, United States

RECRUITING

UCSF Medical Center-Mission Bay

San Francisco, California, 94158, United States

RECRUITING

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Denver, Colorado, 80218, United States

RECRUITING

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

RECRUITING

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803, United States

RECRUITING

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908, United States

RECRUITING

UF Health Cancer Institute - Gainesville

Gainesville, Florida, 32610, United States

RECRUITING

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States

RECRUITING

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207, United States

RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

RECRUITING

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

RECRUITING

AdventHealth Orlando

Orlando, Florida, 32803, United States

RECRUITING

Nemours Children's Hospital

Orlando, Florida, 32827, United States

RECRUITING

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

RECRUITING

Saint Mary's Medical Center

West Palm Beach, Florida, 33407, United States

RECRUITING

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, 30329, United States

RECRUITING

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

RECRUITING

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

RECRUITING

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States

RECRUITING

Lurie Children's Hospital-Chicago

Chicago, Illinois, 60611, United States

RECRUITING

University of Illinois

Chicago, Illinois, 60612, United States

RECRUITING

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

RECRUITING

Advocate Children's Hospital-Oak Lawn

Oak Lawn, Illinois, 60453, United States

RECRUITING

Advocate Children's Hospital-Park Ridge

Park Ridge, Illinois, 60068, United States

RECRUITING

Saint Jude Midwest Affiliate

Peoria, Illinois, 61637, United States

RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

RECRUITING

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

RECRUITING

Blank Children's Hospital

Des Moines, Iowa, 50309, United States

RECRUITING

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States

RECRUITING

Children's Hospital New Orleans

New Orleans, Louisiana, 70118, United States

RECRUITING

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States

RECRUITING

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

RECRUITING

Maine Children's Cancer Program

Scarborough, Maine, 04074, United States

RECRUITING

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

RECRUITING

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

RECRUITING

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

RECRUITING

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600, United States

RECRUITING

Tufts Children's Hospital

Boston, Massachusetts, 02111, United States

ACTIVE NOT RECRUITING

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

C S Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

RECRUITING

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

SUSPENDED

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

ACTIVE NOT RECRUITING

Henry Ford Health Saint John Hospital

Detroit, Michigan, 48236, United States

ACTIVE NOT RECRUITING

Michigan State University

East Lansing, Michigan, 48823, United States

SUSPENDED

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

RECRUITING

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

RECRUITING

Corewell Health Children's

Royal Oak, Michigan, 48073, United States

RECRUITING

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404, United States

RECRUITING

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

RECRUITING

University of Missouri Children's Hospital

Columbia, Missouri, 65212, United States

RECRUITING

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

RECRUITING

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, 68114, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

RECRUITING

Sunrise Hospital and Medical Center

Las Vegas, Nevada, 89109, United States

RECRUITING

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, 89135, United States

RECRUITING

Summerlin Hospital Medical Center

Las Vegas, Nevada, 89144, United States

RECRUITING

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Morristown Medical Center

Morristown, New Jersey, 07960, United States

RECRUITING

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

RECRUITING

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903, United States

RECRUITING

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

RECRUITING

Saint Joseph's Regional Medical Center

Paterson, New Jersey, 07503, United States

RECRUITING

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

RECRUITING

Albany Medical Center

Albany, New York, 12208, United States

RECRUITING

Maimonides Medical Center

Brooklyn, New York, 11219, United States

RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States

RECRUITING

The Steven and Alexandra Cohen Children's Medical Center of New York

New Hyde Park, New York, 11040, United States

RECRUITING

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States

RECRUITING

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

RECRUITING

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

RECRUITING

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

RECRUITING

New York Medical College

Valhalla, New York, 10595, United States

RECRUITING

Mission Hospital

Asheville, North Carolina, 28801, United States

RECRUITING

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

East Carolina University

Greenville, North Carolina, 27834, United States

RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Sanford Broadway Medical Center

Fargo, North Dakota, 58122, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Dayton Children's Hospital

Dayton, Ohio, 45404, United States

RECRUITING

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, 43606, United States

RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Legacy Emanuel Children's Hospital

Portland, Oregon, 97227, United States

RECRUITING

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103, United States

RECRUITING

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

RECRUITING

Penn State Children's Hospital

Hershey, Pennsylvania, 17033, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Prisma Health Richland Hospital

Columbia, South Carolina, 29203, United States

RECRUITING

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, 29605, United States

RECRUITING

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States

RECRUITING

East Tennessee Childrens Hospital

Knoxville, Tennessee, 37916, United States

RECRUITING

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

The Children's Hospital at TriStar Centennial

Nashville, Tennessee, 37203, United States

RECRUITING

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

RECRUITING

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

RECRUITING

Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States

RECRUITING

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

ACTIVE NOT RECRUITING

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

RECRUITING

El Paso Children's Hospital

El Paso, Texas, 79905, United States

RECRUITING

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

RECRUITING

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Covenant Children's Hospital

Lubbock, Texas, 79410, United States

RECRUITING

UMC Cancer Center / UMC Health System

Lubbock, Texas, 79415, United States

RECRUITING

Children's Hospital of San Antonio

San Antonio, Texas, 78207, United States

RECRUITING

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229, United States

RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

RECRUITING

University of Vermont and State Agricultural College

Burlington, Vermont, 05405, United States

RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States

ACTIVE NOT RECRUITING

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204, United States

RECRUITING

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, 98405, United States

RECRUITING

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

RECRUITING

West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States

RECRUITING

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States

RECRUITING

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States

RECRUITING

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States

RECRUITING

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

SUSPENDED

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

SUSPENDED

Janeway Child Health Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

SUSPENDED

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

SUSPENDED

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

SUSPENDED

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

SUSPENDED

Children's Hospital

London, Ontario, N6A 5W9, Canada

SUSPENDED

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

SUSPENDED

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

SUSPENDED

HIMA San Pablo Oncologic Hospital

Caguas, 00726, Puerto Rico

ACTIVE NOT RECRUITING

Related Publications (1)

• Weiss BD, Yanik G, Naranjo A, Zhang FF, Fitzgerald W, Shulkin BL, Parisi MT, Russell H, Grupp S, Pater L, Mattei P, Mosse Y, Lai HA, Jarzembowski JA, Shimada H, Villablanca JG, Giller R, Bagatell R, Park JR, Matthay KK. A safety and feasibility trial of 131 I-MIBG in newly diagnosed high-risk neuroblastoma: A Children's Oncology Group study. Pediatr Blood Cancer. 2021 Oct;68(10):e29117. doi: 10.1002/pbc.29117. Epub 2021 May 24.

  PMID: 34028986 DERIVED

MeSH Terms

Conditions

Ganglioneuroblastoma; Neuroblastoma

Interventions

Stem Cell Transplantation; Specimen Handling; Biopsy; Busulfan; Carboplatin; Cisplatin; 1,2-diaminocyclohexaneplatinum II citrate; Platinum; Cyclophosphamide; Dexrazoxane; Razoxane; dinutuximab; Doxorubicin; etoposide phosphate; Congresses as Topic; Radiation; 3-Iodobenzylguanidine; Isotretinoin; lorlatinib; Magnetic Resonance Spectroscopy; Melphalan; sargramostim; Colony-Stimulating Factors; Thiotepa; Topotecan; Vincristine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Diketopiperazines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Organizations; Health Care Economics and Organizations; Physical Phenomena; Guanidines; Amidines; Iodobenzenes; Benzene Derivatives; Hydrocarbons, Iodinated; Retinoids; Carotenoids; Polyenes; Alkenes; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Terpenes; Pigments, Biological; Biological Factors; Spectrum Analysis; Chemistry Techniques, Analytical; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Proteins; Triethylenephosphoramide; Aziridines; Azirines; Camptothecin; Alkaloids; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Steven G DuBois

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 25, 2017
• Study Start: May 14, 2018
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (152); PR (1); CA (9)