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RecruitingNCT03126916Updated Aug 25, 2026

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

A Phase 3 interventional study of Autologous Hematopoietic Stem Cell Transplantation and Biospecimen Collection in Ganglioneuroblastoma, Ganglioneuroblastoma, Nodular and Neuroblastoma, sponsored by Children's Oncology Group. Recruiting at 164 sites in 3 countries. Open to participants aged 365 Days to 30 Years. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by Children's Oncology Group · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
750
Allocation
Randomized
Ages
365 Days to 30 Years
Sex
All
01

Study 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.

Read the detailed description

PRIMARY OBJECTIVES:

I. To determine in the context of a randomized trial whether the event-free survival (EFS) of patients with newly diagnosed high-risk neuroblastoma (NBL) is improved with the addition of iobenguane I-131 (131I-MIBG) during induction, prior to tandem autologous stem cell transplantation (ASCT).

II. To determine whether the addition of lorlatinib to intensive multimodality therapy for patients with high-risk NBL whose tumors harbor activating point mutations in the ALK gene with a variant allele frequency (VAF) >= 5% results in superior EFS compared to a contemporaneously treated cohort of patients with tumors without documented ALK activating mutations.

SECONDARY OBJECTIVES:

I. To describe the toxicities associated with treatment for high-risk NBL with and without the addition of 131I-MIBG or ALK inhibitor therapy.

II. To estimate EFS and describe toxicity in patients with newly diagnosed high-risk NBL randomized to treatment with an 131I-MIBG-containing induction prior to busulfan/melphalan (BuMel) ASCT.

III. To describe the overall survival (OS) and response rates (evaluated per International Neuroblastoma Response Criteria [INRC] criteria prior to ASCT and prior to post-consolidation therapy) for patients with high-risk neuroblastoma treated with or without 131I-MIBG or ALK inhibitor therapy.

IV. To prospectively evaluate the relationship of response rate per revised International Neuroblastoma Response Criteria (INRC) to EFS and OS in patients with high-risk NBL treated with and without the addition of 131I-MIBG or ALK inhibitor therapy.

EXPLORATORY OBJECTIVES:

I. To evaluate whole body radiation dose, tumor factors, and host factors as potential predictors of efficacy and/or toxicity associated with 131I-MIBG therapy and transplant conditioning.

II. To describe end-Induction response, EFS, and OS according to specific ALK mutations, VAF, ALK amplification, the presence of additional genomic findings, or the ALK inhibitor administered.

III. To characterize changes in tumor markers (circulating tumor deoxyribonucleic acid [DNA], including ALK and other tumor specific genetic aberrations, and circulating GD2) over time in response to protocol therapy.

IV. To correlate results of tumor and host profiling with end-induction response and EFS.

V. To prospectively evaluate EFS for patients with MIBG non-avid high-risk NBL compared to patients with MIBG-avid high-risk NBL who are randomized to treatment without 131I-MIBG.

VI. To correlate Curie scores calculated from 131I-MIBG post-treatment scans with end-induction response, EFS and OS.

VII. To describe changes in image defined risk factors (IDRFs) over the course of induction therapy, with correlation to surgical outcomes and local failure rates following primary tumor resection.

VIII. To define patterns of failure at time of first relapse or progression in patients with high-risk NBL.

IX. To determine the feasibility of prospectively monitoring adverse events using electronic health records.

X. To compare local, central, and computer assisted Curie score assignment at baseline and during therapy in patients with MIBG-avid high-risk NBL.

XI. To compare late toxicities (including impaired organ function and secondary tumor occurrence) in patients treated with 131I-MIBG or ALK inhibitor therapy to late toxicities in patients who have not received these therapies.

XII. To determine the association between household material hardship (HMH) and clinical outcomes, including event free and overall survival, and 131I-MIBG receipt.

XIII. To compare the outcomes (EFS, OS, and toxicity) of patients treated with post-consolidation therapy that does not contain aldesleukin to historical outcome data for patients treated with similar induction and consolidation regimens followed by post-consolidation therapy that contained aldesleukin.

XIV. To characterize and describe longitudinal neuropsychological and behavioral effects of high-risk neuroblastoma therapy.

XV. To evaluate change in neurobehavioral outcomes over time in patients with neuroblastoma treated with high-risk neuroblastoma therapy plus lorlatinib compared to high-risk therapy alone using parent- or self-report measures of adaptive, executive, and psychosocial functioning.

XVI. To characterize the pharmacokinetics and pharmaceutical properties of lorlatinib in children with high-risk neuroblastoma.

XVII. To compare the EFS of patients enrolled on Arm E and treated with lorlatinib to the EFS of a historical control comprised of patients with ALK aberrant disease treated on ANBL0532 (NCT00567567).

XVIII. To describe the EFS of patients enrolled on Arm E according to lorlatinib exposure during post-consolidation.

OUTLINE: Patients are randomized or assigned to 1 of 5 arms.

All patients receive cyclophosphamide intravenously (IV) over 15-30 minutes and topotecan hydrochloride IV over 30 minutes on days 1-5 during cycle 1 of induction therapy in the absence of disease progression or unacceptable toxicity. Patients not assigned to an Arm by the end of cycle 1 may receive an addition cycle of cyclophosphamide and topotecan.

ARM A (CLOSED TO ACCRUAL AS OF SEPTEMBER 28, 2023):

INDUCTION THERAPY: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan hydrochloride IV over 30 minutes on days 1-5 of cycle 2 and cisplatin IV over 4 hours and etoposide phosphate IV over 2 hours on days 1-3 of cycles 3 and 5. Patients also receive vincristine sulfate IV over 1 minute on day 1 and dexrazoxane hydrochloride IV over 5-15 minutes, doxorubicin hydrochloride IV over 1-15 minutes, and cyclophosphamide IV over 1-6 hours on days 1-2 of cycle 4 in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION THERAPY:

HSCT#1: Patients receive thiotepa IV over 2 hours on days -7 to -5 and cyclophosphamide IV over 1 hour on days -5 to -2 in the absence of disease progression or unacceptable toxicity.

HSCT#2: Patients receive melphalan hydrochloride IV over 30 minutes on days -7 to -5, and etoposide phosphate IV over 24 hours and carboplatin IV over 24 hours on days -7 to -4 in the absence of disease progression or unacceptable toxicity.

POST-CONSOLIDATION THERAPY: Patients receive sargramostim subcutaneously (SC) on days 1-14, dinutuximab IV over 10 hours on days 4-7 of cycles 1-5, and isotretinoin orally (PO) twice daily (BID) on days 11-24 of cycles 1-5, and days 15-28 during cycle 6 in the absence of disease progression or unacceptable toxicity.

Patients undergo echocardiography or multigated acquisition (MUGA) scan, magnetic resonance imaging (MRI) or computed tomography (CT) scan, receive 123I-MIBG and undergo MIBG imaging, bone marrow aspiration and biopsy and blood sample collection throughout the study.

ARM B (CLOSED TO ACCRUAL AS OF SEPTEMBER 28, 2023):

INDUCTION THERAPY: Patients receive cyclophosphamide, topotecan hydrochloride, cisplatin, and etoposide phosphate as in Arm A, iobenguane I-131 IV over 1.5-2 hours on day 1 beginning 3 weeks after the start of cycle 3, and vincristine sulfate, dexrazoxane hydrochloride, doxorubicin hydrochloride, and cyclophosphamide as in Arm A beginning no sooner than 35 days after the infusion of iobenguane I-131.

CONSOLIDATION THERAPY:

HSCT#1: Patients receive thiotepa and cyclophosphamide as in Arm A.

HSCT#2: Patients receive melphalan, etoposide phosphate, and carboplatin as in Arm A.

POST-CONSOLIDATION THERAPY: Patients receive sargramostim, dinutuximab, and isotretinoin as in Arm A-D.

Patients undergo echocardiography or MUGA scan, MRI or CT scan, receive 123I-MIGB and undergo MIBG imaging, bone marrow aspiration and biopsy and blood sample collection throughout the study.

ARM C (CLOSED TO ACCRUAL AS OF DECEMBER 17, 2020):

INDUCTION THERAPY: Patients receive cyclophosphamide, topotecan hydrochloride, cisplatin, etoposide phosphate, iobenguane I-131, vincristine sulfate, dexrazoxane hydrochloride, doxorubicin hydrochloride, and cyclophosphamide as in Arm B.

CONSOLIDATION THERAPY: Patients receive busulfan IV over 3 hours on days -6 to -3 and melphalan hydrochloride IV over 30 minutes on day -1 in the absence of disease progression or unacceptable toxicity.

POST-CONSOLIDATION THERAPY: Patients receive sargramostim, dinutuximab, and isotretinoin as in Arm A.

Patients undergo echocardiography or MUGA scan, MRI or CT scan, receive 123I-MIGB and undergo MIBG imaging, bone marrow aspiration and biopsy and blood sample collection throughout the study.

ARM D (CLOSED TO ACCRUAL AS OF SEPTEMBER 28, 2023): Patients receive treatment identical to Arm A.

Patients undergo echocardiography or MUGA scan, MRI or CT scan, receive 123I-MIGB and undergo MIBG imaging, bone marrow aspiration and biopsy and blood sample collection throughout the study and may undergo fludeoxyglucose- positron emission tomography (PET) scan on study.

ARM E:

INDUCTION THERAPY: Patients receive cyclophosphamide, topotecan hydrochloride, cisplatin, etoposide phosphate, vincristine sulfate, dexrazoxane hydrochloride, doxorubicin hydrochloride, and cyclophosphamide as in Arm A. Patients also receive lorlatinib PO once daily (QD) starting with cycle 2 and continue until HSCT #1 in the absence of disease progression or unacceptable toxicity. For patients transferring from ANBL2131 (NCT06172296) to ANBL1531 (NCT03126916) Arm E, protocol therapy on ANBL1531 (NCT03126916) begins with induction cycle 2 on Arm E (topotecan, cyclophosphamide and lorlatinib).

CONSOLIDATION THERAPY:

HSCT#1: Patients receive thiotepa and cyclophosphamide as in Arm A. Patients also receive lorlatinib PO QD until day -8 of HSCT#2 in the absence of disease progression or unacceptable toxicity.

HSCT#2: Patients receive melphalan hydrochloride, etoposide phosphate, carboplatin as in Arm A. Lorlatinib is restarted when patient has reached at least day +14 post-HSCT#2 and is able to tolerate enteral medications, provided there is no evidence of disease progression or unacceptable toxicity.

RADIATION THERAPY: Patients receive lorlatinib PO QD concurrently with radiation therapy in the absence of disease progression or unacceptable toxicity.

POST-CONSOLIDATION THERAPY: Patients receive sargramostim and dinutuximab as in Arm A-D. Patients also receive isotretinoin PO BID on days 11-24 of cycles 1-5 and days 15-28 of cycle 6, and lorlatinib PO QD on days 15-28 of cycles 2-5 and days 1-28 of cycle 6 in the absence of disease progression or unacceptable toxicity.

CONTINUATION THERAPY: Patients receive lorlatinib PO QD on days 1-28. Cycles repeat every 28 days for 18 months in the absence of disease progression or unacceptable toxicity.

Patients undergo echocardiography or MUGA scan, MRI or CT scan, undergo MIBG imaging, bone marrow aspiration and biopsy and blood sample collection throughout the study and may undergo PET scan on study.

After completion of study therapy, patients in Arms A-D are followed up every 3 months for 18 months, and then every 6 months for 42 months; patients in Arm E are followed up every 3 months for 6 months, and then every 6 months for 42 months.

02

Conditions studied

  • Ganglioneuroblastoma
  • Ganglioneuroblastoma, Nodular
  • Neuroblastoma
03

Who can participate

Ages eligible
365 Days to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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:

    • 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
  • FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age, and
  • FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) \< 10 x ULN; for the purposes of this study, ULN for SGPT (ALT) is 45
  • FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Shortening fraction of >= 27% by echocardiogram, or ejection fraction of > 50% by echocardiogram or radionuclide angiogram
  • FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: 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
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): See ANBL2131 (NCT06172296) protocol for eligible high-risk neuroblastoma diagnoses
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): In addition, all patients transferring from ANBL2131 (NCT06172296) to ANBL1531 (NCT03126916) Arm E must have tumors with an ALK aberration
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Given the lack of data with lorlatinib in infant populations, patients transferring from ANBL2131 (NCT06172296) to ANBL1531 (NCT03126916) must be > 1 year of age at time of transfer to ANBL1531 (NCT03126916). Patients \< 1 year of age found to have a qualifying ALK alteration as part of ANBL2131 (NCT06172296) may continue to participate in ANBL2131 (NCT06172296)
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients initially recognized to have high-risk disease must have received no more than one cycle of topotecan/cyclophosphamide either after enrollment to ANBL2131 (NCT06172296) or started emergently prior to enrollment to ANBL2131 (NCT06172296)
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients may have received up to one cycle of intermediate risk chemotherapy prior to initial enrollment to ANBL2131 (NCT06172296)
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients may have received localized emergency radiation to sites of life-threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): In order to facilitate patient transfer and ensure timely distribution of lorlatinib, there are no blood count requirements to meet at time of transfer from ANBL2131 (NCT06172296) to ANBL1531 ((NCT03126916) Arm E. Note the blood count criteria that must be met prior to start of Induction cycle 2 on Arm E. Lorlatinib therapy should start no sooner than day 1 of Induction cycle 2
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): No known irreversible grade 2 or greater atrioventricular (AV) block
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Due the potential psychiatric risks from lorlatinib, patients should not have a personal history of a serious psychiatric disorder requiring pharmacologic intervention or severe enough to be considered life-threatening
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): No known contraindication to PBSC collection. Examples of contraindications might be a weight or size less than the collecting institution deems 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

Exclusion Criteria:

  • 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
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
750 participants (estimated)

Study arms

  • Experimental
    Arm A (chemotherapy, HSCT, EBRT)

    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

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

    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

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

    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

  • Experimental
    Arm D (chemotherapy, HSCT, EBRT)

    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

  • Experimental
    Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

    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

  • ProcedureAutologous Hematopoietic Stem Cell Transplantation

    Undergo autologous HSCT

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

  • ProcedureBiospecimen Collection

    Undergo blood sample collection

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

  • ProcedureBone Marrow Aspiration and Biopsy

    Undergo bone marrow aspiration and biopsy

  • DrugBusulfan

    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

  • DrugCarboplatin

    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

  • DrugCisplatin

    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

  • ProcedureComputed Tomography

    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

  • DrugCyclophosphamide

    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

  • DrugDexrazoxane Hydrochloride

    Given IV

    Also known as: Cardioxane, Totect, Zinecard

  • BiologicalDinutuximab

    Given IV

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

  • DrugDoxorubicin Hydrochloride

    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

  • ProcedureEchocardiography Test

    Undergo echocardiography

    Also known as: EC, Echocardiography

  • DrugEtoposide Phosphate

    Given IV

    Also known as: Etopophos

  • RadiationExternal Beam Radiation Therapy

    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

  • RadiationIobenguane I-123

    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

  • RadiationIobenguane I-131

    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

  • DrugIsotretinoin

    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

  • DrugLorlatinib

    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

  • ProcedureMagnetic Resonance Imaging

    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

  • DrugMelphalan Hydrochloride

    Given IV

    Also known as: Alkeran, Alkerana, Evomela, Hepzato

  • ProcedureMultigated Acquisition Scan

    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

  • ProcedurePositron Emission Tomography

    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

  • BiologicalSargramostim

    Given SC

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

  • ProcedureTherapeutic Conventional Surgery

    Undergo standard of care surgery

  • DrugThiotepa

    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

  • DrugTopotecan Hydrochloride

    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)

  • DrugVincristine Sulfate

    Given IV

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

05

What researchers measure

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.

    Time frame: 3 years

Secondary outcomes

  1. Incidence of adverse events

    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.

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

  2. EFS (Arm C)

    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.

    Time frame: 3 years

  3. Overall survival (OS)

    OS time is calculated from date of randomization or assignment until death, or until last contact if patient is alive.

    Time frame: 3 years

  4. Response rate

    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).

    Time frame: Up to 6 months

06

Study locations

153 of 164 sites recruiting
  • Children's Hospital of Alabama
    Birmingham, Alabama 35233, United States
    Recruiting
  • Phoenix Childrens Hospital
    Phoenix, Arizona 85016, United States
    • Site Public Contact · Contact · 602-546-0920
    • Francis K. Eshun · Principal investigator
    Recruiting
  • Arkansas Children's Hospital
    Little Rock, Arkansas 72202-3591, United States
    • Site Public Contact · Contact · 501-364-7373
    • Michael W. Bishop · Principal investigator
    Recruiting
  • Kaiser Permanente Downey Medical Center
    Downey, California 90242, United States
    • Site Public Contact · Contact · 626-564-3455
    • Robert M. Cooper · Principal investigator
    Recruiting
  • Loma Linda University Medical Center
    Loma Linda, California 92354, United States
    • Site Public Contact · Contact · 909-558-4050
    • Albert Kheradpour · Principal investigator
    Recruiting
  • Children's Hospital Los Angeles
    Los Angeles, California 90027, United States
    • Site Public Contact · Contact · 323-361-4110
    • Araz Marachelian · Principal investigator
    Recruiting
  • Mattel Children's Hospital UCLA
    Los Angeles, California 90095, United States
    • Site Public Contact · Contact · 310-825-6708
    • Satiro N. De Oliveira · Principal investigator
    Recruiting
  • Valley Children's Hospital
    Madera, California 93636, United States
    Recruiting
  • Kaiser Permanente-Oakland
    Oakland, California 94611, United States
    • Site Public Contact · Contact · Kpoct@kp.org · 877-642-4691
    • Aarati V. Rao · Principal investigator
    Recruiting
  • Children's Hospital of Orange County
    Orange, California 92868, United States
    • Site Public Contact · Contact · oncresearch@choc.org · 714-509-8646
    • Elyssa M. Rubin · Principal investigator
    Recruiting
  • Lucile Packard Children's Hospital Stanford University
    Palo Alto, California 94304, United States
    • Site Public Contact · Contact · ccto-office@stanford.edu · 800-694-0012
    • Jay Michael S. Balagtas · Principal investigator
    Recruiting
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California 95817, United States
    • Site Public Contact · Contact · 916-734-3089
    • Marcio H. Malogolowkin · Principal investigator
    Recruiting
  • Rady Children's Hospital - San Diego
    San Diego, California 92123, United States
    • Site Public Contact · Contact · 858-966-5934
    • William D. Roberts · Principal investigator
    Recruiting
  • Naval Medical Center -San Diego
    San Diego, California 92134, United States
    • Site Public Contact · Contact · 619-532-8712
    • Yoko T. Udaka · Principal investigator
    Recruiting
  • UCSF Medical Center-Mission Bay
    San Francisco, California 94158, United States
    • Site Public Contact · Contact · cancertrials@ucsf.edu · 877-827-3222
    • Kieuhoa T. Vo · Principal investigator
    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
    • Site Public Contact · Contact · 860-545-9981
    • Michael S. Isakoff · Principal investigator
    Recruiting
  • Yale University
    New Haven, Connecticut 06520, United States
    • Site Public Contact · Contact · canceranswers@yale.edu · 203-785-5702
    • Farzana Pashankar · Principal investigator
    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
    • Site Public Contact · Contact · cancer-center@ufl.edu · 352-273-8010
    • Brian Stover · Principal investigator
    Recruiting
  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
    Hollywood, Florida 33021, United States
    • Site Public Contact · Contact · OHR@mhs.net · 954-265-1847
    • Iftikhar Hanif · Principal investigator
    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
    • Site Public Contact · Contact · 305-243-2647
    • Meghan McCormick · Principal investigator
    Recruiting
  • Nicklaus Children's Hospital
    Miami, Florida 33155, United States
    • Site Public Contact · Contact · 888-624-2778
    • Maggie E. Fader · Principal investigator
    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
    • Site Public Contact · Contact · Ashley.Repp@jhmi.edu · 727-767-4784
    • Jennifer B. Dean · Principal investigator
    Recruiting
  • Saint Mary's Medical Center
    West Palm Beach, Florida 33407, United States
    • Site Public Contact · Contact · 561-822-4745
    • Matthew D. Ramirez · Principal investigator
    Recruiting
  • Children's Healthcare of Atlanta - Arthur M Blank Hospital
    Atlanta, Georgia 30329, United States
    • Site Public Contact · Contact · Olivia.Floyd@choa.org · 404-785-0232
    • William T. Cash · Principal investigator
    Recruiting
  • Memorial Health University Medical Center
    Savannah, Georgia 31404, United States
    Recruiting
  • Kapiolani Medical Center for Women and Children
    Honolulu, Hawaii 96826, United States
    Suspended
  • Saint Luke's Cancer Institute - Boise
    Boise, Idaho 83712, United States
    • Site Public Contact · Contact · eslinget@slhs.org · 208-381-2774
    • Martha M. Pacheco · Principal investigator
    Recruiting
  • Lurie Children's Hospital-Chicago
    Chicago, Illinois 60611, United States
    • Site Public Contact · Contact · 773-880-4562
    • Elizabeth A. Sokol · Principal investigator
    Recruiting
  • University of Illinois
    Chicago, Illinois 60612, United States
    • Site Public Contact · Contact · 312-355-3046
    • Dipti S. Dighe · Principal investigator
    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
    • Site Public Contact · Contact · 847-723-7570
    • Rebecca E. McFall · Principal investigator
    Recruiting
  • Advocate Children's Hospital-Park Ridge
    Park Ridge, Illinois 60068, United States
    Recruiting
  • OSF Children's Hospital of Illinois
    Peoria, Illinois 61637, United States
    Recruiting
  • Southern Illinois University School of Medicine
    Springfield, Illinois 62702, United States
    • Site Public Contact · Contact · 217-545-7929
    • Gregory P. Brandt · Principal investigator
    Recruiting
  • Riley Hospital for Children
    Indianapolis, Indiana 46202, United States
    • Site Public Contact · Contact · 800-248-1199
    • Sandeep Batra · Principal investigator
    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
    • Site Public Contact · Contact · 800-237-1225
    • Andrew P. Groves · Principal investigator
    Recruiting
  • University of Kentucky/Markey Cancer Center
    Lexington, Kentucky 40536, United States
    • Site Public Contact · Contact · 859-257-3379
    • James T. Badgett · Principal investigator
    Recruiting
  • Children's Hospital New Orleans
    New Orleans, Louisiana 70118, United States
    • Site Public Contact · Contact · 504-894-5377
    • Maria C. Velez-Yanguas · Principal investigator
    Recruiting
  • Ochsner Medical Center Jefferson
    New Orleans, Louisiana 70121, United States
    Recruiting
  • Eastern Maine Medical Center
    Bangor, Maine 04401, United States
    • Site Public Contact · Contact · 207-973-4274
    • Daniel L. Callaway · Principal investigator
    Recruiting
  • Maine Children's Cancer Program
    Scarborough, Maine 04074, United States
    Recruiting
  • University of Maryland/Greenebaum Cancer Center
    Baltimore, Maryland 21201, United States
    • Site Public Contact · Contact · 800-888-8823
    • Teresa A. York · Principal investigator
    Recruiting
  • Sinai Hospital of Baltimore
    Baltimore, Maryland 21215, United States
    • Site Public Contact · Contact · 410-601-9083
    • Jason M. Fixler · Principal investigator
    Recruiting
  • Johns Hopkins University/Sidney Kimmel Cancer Center
    Baltimore, Maryland 21287, United States
    • Site Public Contact · Contact · jhcccro@jhmi.edu · 410-955-8804
    • Allen R. Chen · Principal investigator
    Recruiting
  • Walter Reed National Military Medical Center
    Bethesda, Maryland 20889-5600, United States
    Suspended
  • Tufts Children's Hospital
    Boston, Massachusetts 02111, United States
    Active, not recruiting
  • Massachusetts General Hospital Cancer Center
    Boston, Massachusetts 02114, United States
    • Site Public Contact · Contact · 877-726-5130
    • Suzanne Shusterman · Principal investigator
    Recruiting
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
    • Site Public Contact · Contact · 877-442-3324
    • Suzanne Shusterman · Principal investigator
    Recruiting
  • C S Mott Children's Hospital
    Ann Arbor, Michigan 48109, United States
    • Site Public Contact · Contact · 800-865-1125
    • Rajen Mody · Principal investigator
    Recruiting
  • Children's Hospital of Michigan
    Detroit, Michigan 48201, United States
    Recruiting
  • 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
    • Site Public Contact · Contact · 248-551-7695
    • Marie V. Nelson · Principal investigator
    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
    • Site Public Contact · Contact · 612-624-2620
    • Robin L. Williams · Principal investigator
    Recruiting
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
    • Site Public Contact · Contact · 855-776-0015
    • Wendy Allen-Rhoades · Principal investigator
    Recruiting
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216, United States
    • Site Public Contact · Contact · 601-815-6700
    • Amanda Strobel · Principal investigator
    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
    • Site Public Contact · Contact · info@siteman.wustl.edu · 800-600-3606
    • Frederick S. Huang · Principal investigator
    Recruiting
  • Mercy Hospital Saint Louis
    St Louis, Missouri 63141, United States
    • Site Public Contact · Contact · 314-251-7066
    • Robin D. Hanson · Principal investigator
    Recruiting
  • Children's Hospital and Medical Center of Omaha
    Omaha, Nebraska 68114, United States
    • Site Public Contact · Contact · 402-955-3949
    • Jill C. Beck · Principal investigator
    Recruiting
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
    • Site Public Contact · Contact · unmcrsa@unmc.edu · 402-559-6941
    • Jill C. Beck · Principal investigator
    Recruiting
  • University Medical Center of Southern Nevada
    Las Vegas, Nevada 89102, United States
    • Site Public Contact · Contact · research@sncrf.org · 702-384-0013
    • Alan K. Ikeda · Principal investigator
    Recruiting
  • Sunrise Hospital and Medical Center
    Las Vegas, Nevada 89109, United States
    • Site Public Contact · Contact · research@sncrf.org · 702-384-0013
    • Alan K. Ikeda · Principal investigator
    Recruiting
  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
    Las Vegas, Nevada 89135, United States
    • Site Public Contact · Contact · research@sncrf.org · 702-384-0013
    • Alan K. Ikeda · Principal investigator
    Recruiting
  • Summerlin Hospital Medical Center
    Las Vegas, Nevada 89144, United States
    • Site Public Contact · Contact · research@sncrf.org · 702-384-0013
    • Alan K. Ikeda · Principal investigator
    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
    • Site Public Contact · Contact · 551-996-2897
    • Katharine Offer · Principal investigator
    Recruiting
  • Morristown Medical Center
    Morristown, New Jersey 07960, United States
    • Site Public Contact · Contact · 973-971-5900
    • Kathryn L. Laurie · Principal investigator
    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
    • Site Public Contact · Contact · 732-235-8675
    • Nehal S. Parikh · Principal investigator
    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
    • Site Public Contact · Contact · HallL@sjhmc.org · 973-754-2207
    • Alissa Kahn · Principal investigator
    Recruiting
  • University of New Mexico Cancer Center
    Albuquerque, New Mexico 87106, United States
    Recruiting
  • Albany Medical Center
    Albany, New York 12208, United States
    • Site Public Contact · Contact · 518-262-5513
    • Lauren R. Weintraub · Principal investigator
    Recruiting
  • Maimonides Medical Center
    Brooklyn, New York 11219, United States
    • Site Public Contact · Contact · 718-765-2500
    • Mahmut Y. Celiker · Principal investigator
    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
    • Site Public Contact · Contact · 718-470-3460
    • Julie I. Krystal · Principal investigator
    Recruiting
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone
    New York, New York 10016, United States
    Suspended
  • 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
    • Site Public Contact · Contact · 585-275-5830
    • Jeffrey R. Andolina · Principal investigator
    Recruiting
  • Stony Brook University Medical Center
    Stony Brook, New York 11794, United States
    • Site Public Contact · Contact · 800-862-2215
    • Laura E. Hogan · Principal investigator
    Recruiting
  • State University of New York Upstate Medical University
    Syracuse, New York 13210, United States
    • Site Public Contact · Contact · 315-464-5476
    • Melanie A. Comito · Principal investigator
    Recruiting
  • Montefiore Medical Center - Moses Campus
    The Bronx, New York 10467, United States
    • Site Public Contact · Contact · eskwak@montefiore.org · 718-379-6866
    • Alice Lee · Principal investigator
    Recruiting
  • New York Medical College
    Valhalla, New York 10595, United States
    • Site Public Contact · Contact · 914-594-3794
    • Andrew J. Bellantoni · Principal investigator
    Recruiting
  • Mission Hospital
    Asheville, North Carolina 28801, United States
    Recruiting

Showing the first 100 of 164 sites across 3 countries.

07

References and documents

Publications

  • 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. PubMed 34028986 ↗
08

Registry details

Key details

Study ID
NCT03126916
Lead sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Apr 25, 2017
Start date
May 14, 2018
Primary completion
Sep 30, 2030 (estimated)
Completion
Sep 30, 2030 (estimated)
Last update
Aug 25, 2026

Study contacts

Steven G DuBois
principal investigator · Children's Oncology Group

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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