Clinical Trials /

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

NCT03126916

Description:

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

Related Conditions:
  • Ganglioneuroblastoma
  • Neuroblastoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Iobenguane I-131 or Crizotinib and Standard Therapy in Treating Younger Patients With Newly-Diagnosed High-Risk Neuroblastoma or Ganglioneuroblastoma
  • Official Title: A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Standard Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL)

Clinical Trial IDs

  • ORG STUDY ID: ANBL1531
  • SECONDARY ID: NCI-2016-01734
  • SECONDARY ID: ANBL1531
  • SECONDARY ID: ANBL1531
  • SECONDARY ID: ANBL1531
  • SECONDARY ID: U10CA180886
  • NCT ID: NCT03126916

Conditions

  • Childhood Ganglioneuroblastoma
  • Childhood Neuroblastoma
  • NMYC Gene Amplification
  • Recurrent Neuroblastoma

Interventions

DrugSynonymsArms
Aldesleukin125-L-Serine-2-133-interleukin 2, Proleukin, r-serHuIL-2, Recombinant Human IL-2, Recombinant Human Interleukin-2Arm A (chemotherapy, HSCT, EBRT)
Busulfan1, 4-Bis[methanesulfonoxy]butane, BUS, Bussulfam, Busulfanum, Busulfex, Busulphan, CB 2041, CB-2041, Glyzophrol, GT 41, GT-41, Joacamine, Methanesulfonic Acid Tetramethylene Ester, Methanesulfonic acid, tetramethylene ester, Mielucin, Misulban, Misulfan, Mitosan, Myeleukon, Myeloleukon, Myelosan, Mylecytan, Myleran, Sulfabutin, Tetramethylene Bis(methanesulfonate), Tetramethylene bis[methanesulfonate], WR-19508Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)
CarboplatinBlastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplat, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, RibocarboArm A (chemotherapy, HSCT, EBRT)
CisplatinAbiplatin, 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, PlatosinArm A (chemotherapy, HSCT, EBRT)
CrizotinibMET Tyrosine Kinase Inhibitor PF-02341066, PF-02341066, PF-2341066, XalkoriArm E (crizotinib, chemotherapy, HSCT, EBRT)
Cyclophosphamide(-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719Arm A (chemotherapy, HSCT, EBRT)
Dexrazoxane HydrochlorideCardioxane, Totect, ZinecardArm A (chemotherapy, HSCT, EBRT)
DinutuximabCh 14.18UTC, Ch14.18, MOAB Ch14.18, monoclonal antibody Ch14.18, UnituxinArm A (chemotherapy, HSCT, EBRT)
Doxorubicin Hydrochloride5,12-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, Doxorubin, Farmiblastina, FI 106, FI-106, hydroxydaunorubicin, RubexArm A (chemotherapy, HSCT, EBRT)
Etoposide PhosphateEtopophosArm A (chemotherapy, HSCT, EBRT)
Isotretinoin13-cis retinoic acid, 13-cis-Retinoate, 13-cis-Retinoic Acid, 13-cis-Vitamin A Acid, 13-cRA, Accure, Accutane, Amnesteem, cis-Retinoic Acid, Cistane, Claravis, Isotretinoinum, Isotrex, Isotrexin, Neovitamin A, Neovitamin A Acid, Oratane, Retinoicacid-13-cis, Ro 4-3780, Ro-4-3780, Roaccutan, Roaccutane, Roacutan, SotretArm A (chemotherapy, HSCT, EBRT)
MelphalanAlanine Nitrogen Mustard, CB-3025, L-PAM, L-Phenylalanine Mustard, L-Sarcolysin, L-Sarcolysin Phenylalanine mustard, L-Sarcolysine, Melphalanum, Phenylalanine Mustard, Phenylalanine Nitrogen Mustard, Sarcoclorin, Sarkolysin, WR-19813Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)
Sargramostim23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine, rhu GM-CFS, Sagramostim, SargramostatinArm A (chemotherapy, HSCT, EBRT)
Thiotepa1,1',1''-Phosphinothioylidynetrisaziridine, Girostan, N,N', N''-Triethylenethiophosphoramide, Oncotiotepa, STEPA, Tepadina, TESPA, Tespamin, Tespamine, Thio-Tepa, Thiofosfamide, Thiofozil, Thiophosphamide, Thiophosphoramide, Thiotef, Tifosyl, TIO TEF, Tio-tef, Triethylene Thiophosphoramide, Triethylenethiophosphoramide, Tris(1-aziridinyl)phosphine sulfide, TSPA, WR 45312Arm A (chemotherapy, HSCT, EBRT)
Topotecan HydrochlorideHycamptamine, Hycamtin, SKF S-104864-A, Topotecan HCl, topotecan hydrochloride (oral)Arm A (chemotherapy, HSCT, EBRT)
Vincristine SulfateKyocristine, Leurocristine Sulfate, Leurocristine, sulfate, Oncovin, Vincasar, Vincosid, Vincrex, Vincristine, sulfateArm A (chemotherapy, HSCT, EBRT)

Purpose

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

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 crizotinib to standard multimodality therapy for
      patients with high-risk NBL whose tumors harbor activating point mutations in or
      amplification of the ALK gene results in superior EFS compared to a contemporaneously
      treated cohort of patients whose tumors lack these ALK aberrations.

      SECONDARY OBJECTIVES:

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

      II. To compare EFS and toxicity in patients with newly diagnosed high-risk NBL randomized to
      treatment with an 131I-MIBG-containing induction prior to either tandem or
      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 crizotinib.

      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 crizotinib.

      TERTIARY 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 determine whether the efficacy (end-Induction response, EFS, and OS) of crizotinib is
      associated with specific ALK mutations or ALK amplification.

      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 crizotinib to late toxicities in patients
      who have not received these therapies.

      OUTLINE: Patients are randomized or assigned to 1 of 4 arms.

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

      ARM A:

      INDUCTION THERAPY: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan
      hydrochloride IV over 30 minutes on days 1-5 of course 2 and cisplatin IV over 4 hours and
      etoposide phosphate IV over 2 hours on days 1-3 of courses 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 course 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 IV over 15-30 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 courses 1, 3, and 5 and days 8-11 of courses 2
      and 4, aldesleukin IV over 96 hours on days 1-4 and 8-11 of courses 2 and 4, and
      isotretinoin orally (PO) twice daily (BID) on days 11-24 of courses 1, 3, and 5, and days
      15-28 during courses 2, 4, and 6 in the absence of disease progression or unacceptable
      toxicity.

      ARM B:

      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 course 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-CONSLIDATION THERAPY: Patients receive sargramostim, dinutuximab, aldesleukin, and
      isotretinoin as in Arm A-D.

      ARM C:

      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 IV over 15-30 minutes on day -1 in the absence of disease progression or
      unacceptable toxicity.

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

      ARM D: Patients receive treatment identical to Arm A.

      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 crizotinib PO BID on
      days 1-21 of courses 2-5 in the absence of disease progression or unacceptable toxicity.

      CONSOLIDATION THERAPY:

      HSCT#1: Patients receive thiotepa and cyclophosphamide as in Arm A. Patients also receive
      crizotinib PO BID until day -7 of HSCT#2 in the absence of disease progression or
      unacceptable toxicity.

      HSCT#2: Patients receive melphalan, etoposide phosphate, carboplatin, and crizotinib PO BID
      on days 1-42 in the absence of disease progression or unacceptable toxicity.

      POST-CONSOLIDATION THERAPY: Patients receive sargramostim, dinutuximab, and aldesleukin as
      in Arm A-D. Patients also receive isotretinoin PO BID on days 11-24 of courses 1, 3, and 5,
      and days 15-28 of courses 2 and 4, and crizotinib PO BID on days 1-24 of courses 1, 3 and 5,
      and days 1-28 of courses 2, 4, and 6 in the absence of disease progression or unacceptable
      toxicity.

      CONTINUATION THERAPY: Patients receive crizotinib PO BID on days 1-28. Courses repeat every
      28 days for 1 year in the absence of disease progression or unacceptable toxicity.

      After completion of study therapy, patients in Arms A and 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.
    

Trial Arms

NameTypeDescriptionInterventions
Arm A (chemotherapy, HSCT, EBRT)ExperimentalSee Arm A in detailed description.
  • Carboplatin
  • Cisplatin
  • Cyclophosphamide
  • Dexrazoxane Hydrochloride
  • Doxorubicin Hydrochloride
  • Etoposide Phosphate
  • Isotretinoin
  • Thiotepa
  • Topotecan Hydrochloride
  • Vincristine Sulfate
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)ExperimentalSee Arm B in detailed description.
  • Carboplatin
  • Cisplatin
  • Cyclophosphamide
  • Dexrazoxane Hydrochloride
  • Doxorubicin Hydrochloride
  • Etoposide Phosphate
  • Isotretinoin
  • Thiotepa
  • Topotecan Hydrochloride
  • Vincristine Sulfate
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)ExperimentalSee Arm C in detailed description.
  • Busulfan
  • Cisplatin
  • Cyclophosphamide
  • Dexrazoxane Hydrochloride
  • Doxorubicin Hydrochloride
  • Etoposide Phosphate
  • Isotretinoin
  • Melphalan
  • Thiotepa
  • Topotecan Hydrochloride
  • Vincristine Sulfate
Arm D (chemotherapy, HSCT, EBRT)ExperimentalSee Arm D in detailed description.
  • Carboplatin
  • Cisplatin
  • Cyclophosphamide
  • Dexrazoxane Hydrochloride
  • Doxorubicin Hydrochloride
  • Etoposide Phosphate
  • Isotretinoin
  • Thiotepa
  • Topotecan Hydrochloride
  • Vincristine Sulfate
Arm E (crizotinib, chemotherapy, HSCT, EBRT)ExperimentalSee Arm E in detailed description.
  • Carboplatin
  • Cisplatin
  • Crizotinib
  • Cyclophosphamide
  • Dexrazoxane Hydrochloride
  • Doxorubicin Hydrochloride
  • Etoposide Phosphate
  • Isotretinoin
  • Thiotepa
  • Topotecan Hydrochloride

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must be enrolled on ANBL00B1 or APEC14B1 prior to enrollment on ANBL1531

          -  Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular)
             verified by tumor pathology analysis or demonstration of clumps of tumor cells in
             bone marrow with elevated urinary catecholamine metabolites; the following disease
             groups are eligible:

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

                    -  MYCN amplification (> 4-fold increase in MYCN signals as compared to
                       reference signals), regardless of age or additional biologic features; OR

                    -  Age > 547 days regardless of biologic features

               -  Patients with INRG stage MS disease with MYCN amplification

               -  Patients with INRG stage L2 disease with MYCN amplification

               -  Patients > 547 days of age initially diagnosed with INRG stage L1, L2 or MS
                  disease who progressed to Stage M without prior chemotherapy may enroll within 4
                  weeks of progression to Stage M

               -  Patients > 365 days of age initially diagnosed with MYCN amplified INRG stage L1
                  disease who progress to Stage M without systemic therapy may enroll within 4
                  weeks of progression to stage M

          -  Patients initially recognized to have high-risk disease must have had no prior
             systemic therapy (other than topotecan/cyclophosphamide initiated on an emergent
             basis); patients treated with a single cycle of chemotherapy per a low or
             intermediate risk neuroblastoma regimen (e.g., as per ANBL0531, ANBL1232 or similar)
             for what initially appeared to be non-high risk disease but subsequently found to
             meet the criteria will also be eligible; patients who receive localized emergency
             radiation to sites of life-threatening or function-threatening disease prior to or
             immediately after establishment of the definitive diagnosis will be eligible

          -  Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
             mL/min/1.73 m^2 or a serum creatinine based on age/sex as follows:

               -  1 to < 2 years: male = 0.6; female = 0.6

               -  2 to < 6 years: male = 0.8; female = 0.8

               -  6 to < 10 years: male = 1; female = 1

               -  10 to < 13 years: male = 1.2; female = 1.2

               -  13 to < 16 years: male = 1.5; female = 1.4

               -  >= 16 years: male = 1.7; female = 1.4

          -  Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, and

          -  Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 10 x
             ULN; for the purposes of this study, ULN for SGPT (ALT) is 45

          -  Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by
             echocardiogram or radionuclide angiogram

          -  No known contraindication to peripheral blood stem cell (PBSC) collection; examples
             of contraindications might be a weight or size less than the collecting institution
             finds feasible, or a physical condition that would limit the ability of the child to
             undergo apheresis catheter placement (if necessary) and/or the apheresis procedure

        Exclusion Criteria:

          -  Patients with INRG stage L2 tumors without amplification of MYCN regardless of tumor
             histology (may meet criteria for may meet criteria for high risk classification but
             are not eligible for this trial)

          -  Patients with bone marrow failure syndromes

          -  Patients for whom targeted radiopharmaceutical therapy would be contraindicated due
             to underlying medical disorders

          -  Female patients who are pregnant; a pregnancy test is required for female patients of
             childbearing potential

          -  Lactating females who plan to breastfeed their infants

          -  Sexually active patients of reproductive potential who have not agreed to use an
             effective contraceptive method for the duration of their study participation
      
Maximum Eligible Age:30 Years
Minimum Eligible Age:365 Days
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:EFS rate
Time Frame:From the time of randomization or assignment to first episode of disease relapse or progression, first occurrence of a second malignancy, or death, assessed for up to 5 years
Safety Issue:
Description:Will be assessed with an intent-to-treat log-rank test comparison of EFS rates. The EFS of patients assigned to the ALK-aberrant crizotinib treatment arm will be compared with an intent-to-treat log-rank test to that of all patients assigned to the ALK wild type portion of the trial, except for those patients randomized to receive 131I-MIBG.

Secondary Outcome Measures

Measure:Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria version 4.0
Time Frame:Up to 5 years
Safety Issue:
Description:Will use chi-squared tests to determine incremental increases in toxicity that result from the addition of crizotinib. Separate comparisons for Induction, Consolidation, post-Consolidation (with immunotherapy and with crizotinib monotherapy), and follow-up phases will be performed. Chi-squared and Wilcoxon rank-sum tests will be used to assess incremental increases in toxicity from the addition of 131I-MIBG.
Measure:Non-inferiority of 131I-MIBG plus BuMel and 131I-MIBG plus tandem transplant
Time Frame:Up to 5 years
Safety Issue:
Description:The 131I-MIBG plus BuMel arm will be compared to the 131I-MIBG plus tandem transplant arm, and success will be declared and the 131I-MIBG plus BuMel arm deemed non-inferior to the 131I-MIBG plus tandem transplant arm if the upper boundary of the two-sided 90% confidence interval for the hazard ratio from a Cox proportional hazards model is less than 1.3.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Children's Oncology Group

Last Updated

April 24, 2017