MedPath

A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT

Phase 2
Recruiting
Conditions
Anaplastic Kidney Wilms Tumor
Stage III Kidney Wilms Tumor
Recurrent Kidney Wilms Tumor
Stage II Kidney Wilms Tumor
Stage IV Kidney Wilms Tumor
Interventions
Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Bone Scan
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
Radiation: Radiation Therapy
Procedure: Surgical Procedure
Procedure: Transabdominal Ultrasound
Procedure: X-Ray Imaging
Registration Number
NCT04322318
Lead Sponsor
Children's Oncology Group
Brief Summary

This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out what effects, good and/or bad, regimen UH-3 has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT) and regimen ICE/Cyclo/Topo has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate whether the addition of vincristine/irinotecan to cyclophosphamide/ carboplatin/etoposide alternating with vincristine/doxorubicin/cyclophosphamide improves the event-free survival (EFS) of patients with newly diagnosed stage 4 diffuse anaplastic Wilms tumor (DAWT) as compared to historical controls.

II. To evaluate whether the addition of vincristine/irinotecan to cyclophosphamide/carboplatin/etoposide alternating with vincristine/doxorubicin/cyclophosphamide improves the EFS of patients with standard-risk relapsed favorable histology Wilms tumor (SRrFHWT) as compared to historical controls.

SECONDARY OBJECTIVES:

I. To evaluate whether the addition of vincristine/irinotecan to cyclophosphamide/carboplatin/etoposide alternating with vincristine/doxorubicin/cyclophosphamide improves the overall survival (OS) of patients with newly diagnosed stage 4 DAWT as compared to historical controls.

II. To evaluate whether the addition of vincristine/irinotecan to cyclophosphamide/carboplatin/etoposide alternating with vincristine/doxorubicin/cyclophosphamide improves the OS of patients with SRrFHWT as compared to historical controls.

III. To evaluate whether the addition of vincristine/irinotecan to cyclophosphamide/carboplatin/etoposide alternating with vincristine/doxorubicin/cyclophosphamide improves the EFS and OS of patients with newly diagnosed stage 2 and 3 DAWT as compared to historical controls.

IV. To establish EFS and OS for high-risk (HRrFHWT) and very high risk (VHRrFHWT) relapsed favorable histology Wilms tumor treated with ifosfamide/carboplatin/etoposide alternating with cyclophosphamide/ topotecan.

EXPLORATORY OBJECTIVES:

I. To describe renal toxicity of ifosfamide/carboplatin/etoposide in HRrFHWT and VHRrFHWT patients using conventional and novel biomarkers of renal toxicity (urine NGAL, cystatin C and Kim1) in the context of the chemotherapy regimens used on this study.

II. To collect and bank serial blood and urine samples in patients with newly diagnosed DAWT or relapsed FHWT and tumor tissue in patients with relapsed FHWT, for future analysis.

III. To assess the impact of p53 gene and protein expression on outcome for patients with newly diagnosed DAWT.

IV. To determine EFS/OS in the subsets of patients with newly diagnosed DAWT or relapsed FWHT who undergo gross total resection at all disease sites at diagnosis or after neoadjuvant chemotherapy.

V. To describe the rate of regional lymph node sampling at the time of nephrectomy with the use of a pre-operative surgical checklist for patients with newly diagnosed DAWT.

VI. To determine the feasibility of intensity modulated radiation therapy (IMRT) with central quality assurance (QA) monitoring to reduce radiation induced toxicity to the heart, thyroid, breast and solitary kidney for children with lung and liver metastases (part of an overarching aim in this study and across frontline favorable histology Wilms tumor studies).

VII. To validate that circulating tumor-derived deoxyribonucleic acid (ctDNA) can identify high-risk genomic features, define prognostic risk groups, and identify patterns of tumor evolution associated with the development of treatment resistance.

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM I (REGIMEN UH-3):

CYCLES 1, 5, 7, 10, AND 13: Patients receive vincristine intravenously (IV) via minibag per institutional policy on days 1, 8, and 15. Patients also receive doxorubicin IV over 1-15 minutes and cyclophosphamide IV over 30-60 minutes on day 1. Treatment repeats every 21 days during cycles 1, 5, 7, 10, and 13 in the absence of disease progression or unacceptable toxicity.

CYCLES 2, 6, 9, 12, AND 14: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive cyclophosphamide IV over 15-30 minutes and etoposide IV over 1-2 hours on days 1-4. Treatment repeats every 21 days during cycles 2, 6, 9, 12, and 14 in the absence of disease progression or unacceptable toxicity.

CYCLES 3, 4, 8, AND 11: Patients receive vincristine IV via minibag per institutional policy on days 1 and 8 and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 4, 8, and 11 in the absence of disease progression or unacceptable toxicity.

Patients undergo radiation therapy (RT) at week 7 of cycle 3 as clinically indicated. Patients undergo a computed tomography (CT) scan, a positron emission tomography (PET) scan, a chest x-ray, magnetic resonance imaging (MRI), an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial.

ARM II (REGIMEN IFOSFAMIDE, CARBOPLATIN, ETOPOSIDE \[ICE\]/CYCLOPHOSPHAMIDE \[CYCLO\]/TOPOTECAN \[TOPO\]):

CYCLES 1, 2, 4, 5, 7, AND 9: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and ifosfamide IV over 2-4 hours on days 1-3. Treatment repeats every 21 days during cycles 1, 2, 4, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity.

CYCLES 3, 6, 8, AND 10: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 6, 8, and 10 in the absence of disease progression or unacceptable toxicity.

Patients undergo surgery and/or RT during cycles 4, 7, and 10 as clinically indicated. Patients undergo a CT scan, a PET scan, a chest x-ray, MRI, an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial.

After completion of study treatment, patients are followed up every 3 months for years 1-2, every 6 months for years 3-4, and once at year 5.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
256
Inclusion Criteria
  • Patients with newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on APEC14B1, consented to Part A - Eligibility Screening, and have received an initial stratum assignment showing DAWT (if anaplasia first identified at diagnostic, pre-treatment nephrectomy or biopsy) or a final stratum assignment showing DAWT (if anaplasia first noted at delayed nephrectomy) prior to enrollment on AREN1921. Prior enrollment on APEC14B1 is not an eligibility requirement for patients with relapsed favorable histology Wilms tumor.

  • Patients must be =< 30 years old at study enrollment

  • Patients with the following diagnoses are eligible for this study:

    • Newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor as confirmed by central review

    • Favorable histology Wilms tumor at first relapse. Relapsed FHWT patients must have previously achieved remission for their initial FHWT diagnosis to be eligible for this study. The relapse risk groups are defined as follows, regardless of radiation therapy:

      • Standard-Risk relapse: Patients who received two chemotherapy agents for frontline therapy; primarily actinomycin D and vincristine
      • High-Risk relapse: Patients who received three chemotherapy agents for frontline therapy; primarily vincristine, actinomycin D and doxorubicin or vincristine, actinomycin D and irinotecan
      • Very High-Risk relapse: Patients who received four or more chemotherapy agents as part of initial therapy; primarily regimen M or its variations
  • Patients with newly diagnosed DAWT must have had histologic verification of the malignancy. For relapsed FHWT patients, biopsy to prove recurrence is encouraged, but not required

    • Note: For relapsed FHWT patients, an institutional pathology report confirming favorable histology Wilms tumor (from relapse, if available, or from original diagnosis) must be available for upload prior to initiation of protocol therapy
  • Patients with newly diagnosed Stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on AREN1921 within 2 weeks of the tumor-directed surgery or biopsy procedure that first confirms a diagnosis of DAWT, whether at initial diagnostic procedure or delayed nephrectomy (such surgery/biopsy is day 0). For patients who received prior therapy for presumed favorable histology Wilms tumor, later confirmed to have diffuse anaplastic Wilms tumor at subsequent review of the initial biopsy

  • Patients with newly diagnosed DAWT who undergo upfront nephrectomy must have at least 1 lymph node sampled prior to study enrollment

  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age

  • Patients must have a life expectancy of >= 8 weeks

  • Diffuse Anaplastic Wilms Tumor: Patients with diffuse anaplastic histology must have had no prior systemic therapy, except in the following situations:

    • Patients with diffuse anaplastic Wilms tumor who received no more than 12 weeks of pre nephrectomy chemotherapy for what was originally presumed to be favorable histology Wilms tumor, subsequently confirmed to be diffuse anaplastic Wilms tumor at delayed nephrectomy
    • Patients with diffuse anaplastic Wilms tumor who received no more than 6 weeks of chemotherapy following upfront biopsy, initiated within 14 days of biopsy, for presumed favorable histology Wilms tumor based on institutional review, but subsequently corrected to diffuse anaplastic Wilms tumor based on the initial stratum assignment on APEC14B1-REN
    • Treatment consisting of vincristine/doxorubicin/cyclophosphamide initiated on an emergent basis and within allowed timing as described
    • Note: Patients who received prior therapy for presumed favorable histology Wilms tumor, later identified to have diffuse anaplastic Wilms tumor as per above, must begin study treatment starting at cycle 3 (week 7) of regimen UH 3. Patients who received emergency radiation to preserve organ function are eligible as noted. Patients who received radiation as part of standard of care for presumed newly diagnosed favorable histology Wilms tumor, along with chemotherapy as noted above, prior to identification of diffuse anaplasia, are also eligible
  • Relapsed Favorable Histology Wilms Tumor: Patients must not have received prior chemotherapy for their relapsed favorable histology Wilms tumor diagnosis. In addition, patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study

    • Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study
    • Radiation therapy (RT): >= 2 weeks (wks) must have elapsed for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 wks must have elapsed if other substantial bone marrow (BM) radiation. Patients with relapsed favorable histology Wilms tumor who received emergency radiation to preserve organ function are eligible and do not need to washout with the above criteria
  • Patients may not be receiving any other investigational agents (within 4 weeks prior to study enrollment)

  • Peripheral absolute neutrophil count (ANC) >= 750/uL (performed within 7 days prior to enrollment)

  • Platelet count >= 75,000/uL (transfusion independent) (performed within 7 days prior to enrollment)

  • Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) (performed within 7 days prior to enrollment)

  • Patients with high-risk or very high-risk relapsed FHWT who will be treated with regimen ICE/Cyclo/Topo, must have renal function assessed by creatinine clearance or radioisotope glomerular filtration rate (GFR) and meet the following requirement:

    • Creatinine clearance or radioisotope GFR >= 60 mL/min/1.73 m^2 (performed within 7 days prior to enrollment)
  • Patients diagnosed with stage 2-4 DAWT or standard risk relapsed FHWT, who will be treated with regimen UH 3, may either obtain a creatinine clearance, radioisotope GFR (meeting the above criteria of GFR >= 60 mL/min/1.73 m^2), or an adequate serum creatinine as per the following table:

    • Age: Maximum Serum Creatinine (mg/dL)
    • 1 month to < 6 months: 0.4 (male and female)
    • 6 months to < 1 year: 0.5 (male and female)
    • 1 to < 2 years: 0.6 (male and female)
    • 2 to < 6 years: 0.8 (male and female)
    • 6 to < 10 years: 1 (male and female)
    • 10 to < 13 years: 1.2 (male and female)
    • 13 to < 16 years: 1.5 (male), 1.4 (female)
    • >= 16 years: 1.7 (male), 1.4 (female)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age or direct bilirubin =< ULN for patients whose total bilirubin > 1.5 x ULN (performed within 7 days prior to enrollment)

  • Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age or =< 5 x ULN for patients with liver metastases (performed within 7 days prior to enrollment)

  • Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by radionuclide angiogram (obtained within 21 days prior to enrollment and start of protocol therapy)

Exclusion Criteria
  • Patients with a history of bilateral Wilms tumor (synchronous or metachronous)

  • Patients with any uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, or symptomatic congestive heart failure (defined as grade 2 or higher heart failure per Common Terminology Criteria for Adverse Events [CTCAE] version 5.0)

  • Relapsed FHWT patients who did not receive frontline chemotherapy (e.g., very low risk FHWT initially observed without chemotherapy) or received only one chemotherapy agent for frontline therapy

  • For patients with high-risk or very high-risk relapsed FHWT:

    • Patients with renal tubular acidosis (RTA) as evidenced by serum bicarbonate < 16 mmol/L and serum phosphate =< 2 mg/dL (or < 0.8 mmol/L) without supplementation
  • For stages 2-4 DAWT and standard-risk relapsed FHWT patients:

    • Chronic inflammatory bowel disease and/or bowel obstruction
    • Concomitant use of St. John's wort, which cannot be stopped prior to the start of trial treatment
  • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential

  • Lactating females who plan to breastfeed their infants

  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Arm I (Regimen UH-3)Biopsy ProcedureSee outline in detailed description section.
Arm I (Regimen UH-3)Biospecimen CollectionSee outline in detailed description section.
Arm I (Regimen UH-3)Bone ScanSee outline in detailed description section.
Arm I (Regimen UH-3)CarboplatinSee outline in detailed description section.
Arm I (Regimen UH-3)Computed TomographySee outline in detailed description section.
Arm I (Regimen UH-3)CyclophosphamideSee outline in detailed description section.
Arm I (Regimen UH-3)DoxorubicinSee outline in detailed description section.
Arm I (Regimen UH-3)EtoposideSee outline in detailed description section.
Arm I (Regimen UH-3)IrinotecanSee outline in detailed description section.
Arm I (Regimen UH-3)Magnetic Resonance ImagingSee outline in detailed description section.
Arm I (Regimen UH-3)Positron Emission TomographySee outline in detailed description section.
Arm I (Regimen UH-3)Radiation TherapySee outline in detailed description section.
Arm I (Regimen UH-3)Transabdominal UltrasoundSee outline in detailed description section.
Arm I (Regimen UH-3)VincristineSee outline in detailed description section.
Arm I (Regimen UH-3)X-Ray ImagingSee outline in detailed description section.
Arm II (Regimen ICE/Cyclo/Topo)Biopsy ProcedureCYCLES 1, 2, 4, 5, 7, AND 9: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and ifosfamide IV over 2-4 hours on days 1-3. Treatment repeats every 21 days during cycles 1, 2, 4, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity. CYCLES 3, 6, 8, AND 10: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 6, 8, and 10 in the absence of disease progression or unacceptable toxicity. Patients undergo surgery and/or RT during cycles 4, 7, and 10 as clinically indicated. Patients undergo a CT scan, a PET scan, a chest x-ray, MRI, an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial.
Arm II (Regimen ICE/Cyclo/Topo)Biospecimen CollectionCYCLES 1, 2, 4, 5, 7, AND 9: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and ifosfamide IV over 2-4 hours on days 1-3. Treatment repeats every 21 days during cycles 1, 2, 4, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity. CYCLES 3, 6, 8, AND 10: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 6, 8, and 10 in the absence of disease progression or unacceptable toxicity. Patients undergo surgery and/or RT during cycles 4, 7, and 10 as clinically indicated. Patients undergo a CT scan, a PET scan, a chest x-ray, MRI, an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial.
Arm II (Regimen ICE/Cyclo/Topo)Bone ScanCYCLES 1, 2, 4, 5, 7, AND 9: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and ifosfamide IV over 2-4 hours on days 1-3. Treatment repeats every 21 days during cycles 1, 2, 4, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity. CYCLES 3, 6, 8, AND 10: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 6, 8, and 10 in the absence of disease progression or unacceptable toxicity. Patients undergo surgery and/or RT during cycles 4, 7, and 10 as clinically indicated. Patients undergo a CT scan, a PET scan, a chest x-ray, MRI, an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial.
Arm II (Regimen ICE/Cyclo/Topo)CarboplatinCYCLES 1, 2, 4, 5, 7, AND 9: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and ifosfamide IV over 2-4 hours on days 1-3. Treatment repeats every 21 days during cycles 1, 2, 4, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity. CYCLES 3, 6, 8, AND 10: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 6, 8, and 10 in the absence of disease progression or unacceptable toxicity. Patients undergo surgery and/or RT during cycles 4, 7, and 10 as clinically indicated. Patients undergo a CT scan, a PET scan, a chest x-ray, MRI, an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial.
Arm II (Regimen ICE/Cyclo/Topo)Computed TomographyCYCLES 1, 2, 4, 5, 7, AND 9: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and ifosfamide IV over 2-4 hours on days 1-3. Treatment repeats every 21 days during cycles 1, 2, 4, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity. CYCLES 3, 6, 8, AND 10: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 6, 8, and 10 in the absence of disease progression or unacceptable toxicity. Patients undergo surgery and/or RT during cycles 4, 7, and 10 as clinically indicated. Patients undergo a CT scan, a PET scan, a chest x-ray, MRI, an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial.
Arm II (Regimen ICE/Cyclo/Topo)Radiation TherapyCYCLES 1, 2, 4, 5, 7, AND 9: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and ifosfamide IV over 2-4 hours on days 1-3. Treatment repeats every 21 days during cycles 1, 2, 4, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity. CYCLES 3, 6, 8, AND 10: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 6, 8, and 10 in the absence of disease progression or unacceptable toxicity. Patients undergo surgery and/or RT during cycles 4, 7, and 10 as clinically indicated. Patients undergo a CT scan, a PET scan, a chest x-ray, MRI, an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial.
Arm II (Regimen ICE/Cyclo/Topo)Surgical ProcedureCYCLES 1, 2, 4, 5, 7, AND 9: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and ifosfamide IV over 2-4 hours on days 1-3. Treatment repeats every 21 days during cycles 1, 2, 4, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity. CYCLES 3, 6, 8, AND 10: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 6, 8, and 10 in the absence of disease progression or unacceptable toxicity. Patients undergo surgery and/or RT during cycles 4, 7, and 10 as clinically indicated. Patients undergo a CT scan, a PET scan, a chest x-ray, MRI, an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial.
Arm II (Regimen ICE/Cyclo/Topo)TopotecanCYCLES 1, 2, 4, 5, 7, AND 9: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and ifosfamide IV over 2-4 hours on days 1-3. Treatment repeats every 21 days during cycles 1, 2, 4, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity. CYCLES 3, 6, 8, AND 10: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 6, 8, and 10 in the absence of disease progression or unacceptable toxicity. Patients undergo surgery and/or RT during cycles 4, 7, and 10 as clinically indicated. Patients undergo a CT scan, a PET scan, a chest x-ray, MRI, an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial.
Arm II (Regimen ICE/Cyclo/Topo)Transabdominal UltrasoundCYCLES 1, 2, 4, 5, 7, AND 9: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and ifosfamide IV over 2-4 hours on days 1-3. Treatment repeats every 21 days during cycles 1, 2, 4, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity. CYCLES 3, 6, 8, AND 10: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 6, 8, and 10 in the absence of disease progression or unacceptable toxicity. Patients undergo surgery and/or RT during cycles 4, 7, and 10 as clinically indicated. Patients undergo a CT scan, a PET scan, a chest x-ray, MRI, an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial.
Arm II (Regimen ICE/Cyclo/Topo)X-Ray ImagingCYCLES 1, 2, 4, 5, 7, AND 9: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and ifosfamide IV over 2-4 hours on days 1-3. Treatment repeats every 21 days during cycles 1, 2, 4, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity. CYCLES 3, 6, 8, AND 10: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 6, 8, and 10 in the absence of disease progression or unacceptable toxicity. Patients undergo surgery and/or RT during cycles 4, 7, and 10 as clinically indicated. Patients undergo a CT scan, a PET scan, a chest x-ray, MRI, an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial.
Arm II (Regimen ICE/Cyclo/Topo)CyclophosphamideCYCLES 1, 2, 4, 5, 7, AND 9: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and ifosfamide IV over 2-4 hours on days 1-3. Treatment repeats every 21 days during cycles 1, 2, 4, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity. CYCLES 3, 6, 8, AND 10: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 6, 8, and 10 in the absence of disease progression or unacceptable toxicity. Patients undergo surgery and/or RT during cycles 4, 7, and 10 as clinically indicated. Patients undergo a CT scan, a PET scan, a chest x-ray, MRI, an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial.
Arm II (Regimen ICE/Cyclo/Topo)EtoposideCYCLES 1, 2, 4, 5, 7, AND 9: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and ifosfamide IV over 2-4 hours on days 1-3. Treatment repeats every 21 days during cycles 1, 2, 4, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity. CYCLES 3, 6, 8, AND 10: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 6, 8, and 10 in the absence of disease progression or unacceptable toxicity. Patients undergo surgery and/or RT during cycles 4, 7, and 10 as clinically indicated. Patients undergo a CT scan, a PET scan, a chest x-ray, MRI, an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial.
Arm II (Regimen ICE/Cyclo/Topo)IfosfamideCYCLES 1, 2, 4, 5, 7, AND 9: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and ifosfamide IV over 2-4 hours on days 1-3. Treatment repeats every 21 days during cycles 1, 2, 4, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity. CYCLES 3, 6, 8, AND 10: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 6, 8, and 10 in the absence of disease progression or unacceptable toxicity. Patients undergo surgery and/or RT during cycles 4, 7, and 10 as clinically indicated. Patients undergo a CT scan, a PET scan, a chest x-ray, MRI, an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial.
Arm II (Regimen ICE/Cyclo/Topo)Magnetic Resonance ImagingCYCLES 1, 2, 4, 5, 7, AND 9: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and ifosfamide IV over 2-4 hours on days 1-3. Treatment repeats every 21 days during cycles 1, 2, 4, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity. CYCLES 3, 6, 8, AND 10: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 6, 8, and 10 in the absence of disease progression or unacceptable toxicity. Patients undergo surgery and/or RT during cycles 4, 7, and 10 as clinically indicated. Patients undergo a CT scan, a PET scan, a chest x-ray, MRI, an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial.
Arm II (Regimen ICE/Cyclo/Topo)Positron Emission TomographyCYCLES 1, 2, 4, 5, 7, AND 9: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and ifosfamide IV over 2-4 hours on days 1-3. Treatment repeats every 21 days during cycles 1, 2, 4, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity. CYCLES 3, 6, 8, AND 10: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 6, 8, and 10 in the absence of disease progression or unacceptable toxicity. Patients undergo surgery and/or RT during cycles 4, 7, and 10 as clinically indicated. Patients undergo a CT scan, a PET scan, a chest x-ray, MRI, an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial.
Primary Outcome Measures
NameTimeMethod
Event-free survival (EFS) for stratum 1-3From study entry to the earliest of relapse or disease progression, second malignant neoplasm, or death from any cause, assessed up to 5 years from study entry

Kaplan-Meier method will be used to estimate EFS, defined as the time from study entry until relapse or disease progression, secondary malignancy, or death.

EFS for stratum 4From study entry to the earliest of relapse or disease progression, second malignant neoplasm, or death from any cause, assessed up to 5 years from study entry

Kaplan-Meier method will be used to estimate 4-year EFS, defined as the time from study entry until relapse or disease progression, secondary malignancy, or death.

Secondary Outcome Measures
NameTimeMethod
Overall survival (OS) for stratum 1-4From study entry to death due to any cause, assessed up to 5 years from study entry

The Kaplan-Meier method will be used to estimate OS, defined as the time from study entry until death.

Trial Locations

Locations (199)

Children's Hospital of Alabama

🇺🇸

Birmingham, Alabama, United States

USA Health Strada Patient Care Center

🇺🇸

Mobile, Alabama, United States

Providence Alaska Medical Center

🇺🇸

Anchorage, Alaska, United States

Banner Children's at Desert

🇺🇸

Mesa, Arizona, United States

Phoenix Childrens Hospital

🇺🇸

Phoenix, Arizona, United States

Banner University Medical Center - Tucson

🇺🇸

Tucson, Arizona, United States

Arkansas Children's Hospital

🇺🇸

Little Rock, Arkansas, United States

Kaiser Permanente Downey Medical Center

🇺🇸

Downey, California, United States

Loma Linda University Medical Center

🇺🇸

Loma Linda, California, United States

Miller Children's and Women's Hospital Long Beach

🇺🇸

Long Beach, California, United States

Children's Hospital Los Angeles

🇺🇸

Los Angeles, California, United States

Cedars Sinai Medical Center

🇺🇸

Los Angeles, California, United States

Mattel Children's Hospital UCLA

🇺🇸

Los Angeles, California, United States

Valley Children's Hospital

🇺🇸

Madera, California, United States

UCSF Benioff Children's Hospital Oakland

🇺🇸

Oakland, California, United States

Kaiser Permanente-Oakland

🇺🇸

Oakland, California, United States

Children's Hospital of Orange County

🇺🇸

Orange, California, United States

Lucile Packard Children's Hospital Stanford University

🇺🇸

Palo Alto, California, United States

University of California Davis Comprehensive Cancer Center

🇺🇸

Sacramento, California, United States

Rady Children's Hospital - San Diego

🇺🇸

San Diego, California, United States

UCSF Medical Center-Mission Bay

🇺🇸

San Francisco, California, United States

Children's Hospital Colorado

🇺🇸

Aurora, Colorado, United States

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

🇺🇸

Denver, Colorado, United States

Connecticut Children's Medical Center

🇺🇸

Hartford, Connecticut, United States

Yale University

🇺🇸

New Haven, Connecticut, United States

Alfred I duPont Hospital for Children

🇺🇸

Wilmington, Delaware, United States

MedStar Georgetown University Hospital

🇺🇸

Washington, District of Columbia, United States

Children's National Medical Center

🇺🇸

Washington, District of Columbia, United States

Golisano Children's Hospital of Southwest Florida

🇺🇸

Fort Myers, Florida, United States

University of Florida Health Science Center - Gainesville

🇺🇸

Gainesville, Florida, United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

🇺🇸

Hollywood, Florida, United States

Nemours Children's Clinic-Jacksonville

🇺🇸

Jacksonville, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

🇺🇸

Miami, Florida, United States

Nicklaus Children's Hospital

🇺🇸

Miami, Florida, United States

Arnold Palmer Hospital for Children

🇺🇸

Orlando, Florida, United States

Nemours Children's Hospital

🇺🇸

Orlando, Florida, United States

Sacred Heart Hospital

🇺🇸

Pensacola, Florida, United States

Johns Hopkins All Children's Hospital

🇺🇸

Saint Petersburg, Florida, United States

Tampa General Hospital

🇺🇸

Tampa, Florida, United States

Saint Joseph's Hospital/Children's Hospital-Tampa

🇺🇸

Tampa, Florida, United States

Saint Mary's Medical Center

🇺🇸

West Palm Beach, Florida, United States

Children's Healthcare of Atlanta - Arthur M Blank Hospital

🇺🇸

Atlanta, Georgia, United States

Atrium Health Navicent

🇺🇸

Macon, Georgia, United States

Memorial Health University Medical Center

🇺🇸

Savannah, Georgia, United States

Kapiolani Medical Center for Women and Children

🇺🇸

Honolulu, Hawaii, United States

Saint Luke's Cancer Institute - Boise

🇺🇸

Boise, Idaho, United States

Lurie Children's Hospital-Chicago

🇺🇸

Chicago, Illinois, United States

University of Illinois

🇺🇸

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

🇺🇸

Chicago, Illinois, United States

Loyola University Medical Center

🇺🇸

Maywood, Illinois, United States

Advocate Children's Hospital-Oak Lawn

🇺🇸

Oak Lawn, Illinois, United States

Advocate Children's Hospital-Park Ridge

🇺🇸

Park Ridge, Illinois, United States

Saint Jude Midwest Affiliate

🇺🇸

Peoria, Illinois, United States

Southern Illinois University School of Medicine

🇺🇸

Springfield, Illinois, United States

Riley Hospital for Children

🇺🇸

Indianapolis, Indiana, United States

Ascension Saint Vincent Indianapolis Hospital

🇺🇸

Indianapolis, Indiana, United States

Blank Children's Hospital

🇺🇸

Des Moines, Iowa, United States

University of Iowa/Holden Comprehensive Cancer Center

🇺🇸

Iowa City, Iowa, United States

University of Kentucky/Markey Cancer Center

🇺🇸

Lexington, Kentucky, United States

Norton Children's Hospital

🇺🇸

Louisville, Kentucky, United States

Children's Hospital New Orleans

🇺🇸

New Orleans, Louisiana, United States

Ochsner Medical Center Jefferson

🇺🇸

New Orleans, Louisiana, United States

Eastern Maine Medical Center

🇺🇸

Bangor, Maine, United States

Maine Children's Cancer Program

🇺🇸

Scarborough, Maine, United States

Sinai Hospital of Baltimore

🇺🇸

Baltimore, Maryland, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

🇺🇸

Baltimore, Maryland, United States

Tufts Children's Hospital

🇺🇸

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

🇺🇸

Boston, Massachusetts, United States

UMass Memorial Medical Center - University Campus

🇺🇸

Worcester, Massachusetts, United States

C S Mott Children's Hospital

🇺🇸

Ann Arbor, Michigan, United States

Children's Hospital of Michigan

🇺🇸

Detroit, Michigan, United States

Michigan State University Clinical Center

🇺🇸

East Lansing, Michigan, United States

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

🇺🇸

Grand Rapids, Michigan, United States

Bronson Methodist Hospital

🇺🇸

Kalamazoo, Michigan, United States

Corewell Health Children's

🇺🇸

Royal Oak, Michigan, United States

Children's Hospitals and Clinics of Minnesota - Minneapolis

🇺🇸

Minneapolis, Minnesota, United States

University of Minnesota/Masonic Cancer Center

🇺🇸

Minneapolis, Minnesota, United States

Mayo Clinic in Rochester

🇺🇸

Rochester, Minnesota, United States

University of Mississippi Medical Center

🇺🇸

Jackson, Mississippi, United States

University of Missouri Children's Hospital

🇺🇸

Columbia, Missouri, United States

Children's Mercy Hospitals and Clinics

🇺🇸

Kansas City, Missouri, United States

Cardinal Glennon Children's Medical Center

🇺🇸

Saint Louis, Missouri, United States

Washington University School of Medicine

🇺🇸

Saint Louis, Missouri, United States

Mercy Hospital Saint Louis

🇺🇸

Saint Louis, Missouri, United States

Children's Hospital and Medical Center of Omaha

🇺🇸

Omaha, Nebraska, United States

University of Nebraska Medical Center

🇺🇸

Omaha, Nebraska, United States

University Medical Center of Southern Nevada

🇺🇸

Las Vegas, Nevada, United States

Sunrise Hospital and Medical Center

🇺🇸

Las Vegas, Nevada, United States

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

🇺🇸

Las Vegas, Nevada, United States

Summerlin Hospital Medical Center

🇺🇸

Las Vegas, Nevada, United States

Renown Regional Medical Center

🇺🇸

Reno, Nevada, United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

🇺🇸

Lebanon, New Hampshire, United States

Hackensack University Medical Center

🇺🇸

Hackensack, New Jersey, United States

Morristown Medical Center

🇺🇸

Morristown, New Jersey, United States

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

🇺🇸

New Brunswick, New Jersey, United States

Newark Beth Israel Medical Center

🇺🇸

Newark, New Jersey, United States

Saint Joseph's Regional Medical Center

🇺🇸

Paterson, New Jersey, United States

Albany Medical Center

🇺🇸

Albany, New York, United States

Montefiore Medical Center - Moses Campus

🇺🇸

Bronx, New York, United States

Roswell Park Cancer Institute

🇺🇸

Buffalo, New York, United States

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

🇺🇸

New Hyde Park, New York, United States

Mount Sinai Hospital

🇺🇸

New York, New York, United States

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

🇺🇸

New York, New York, United States

Memorial Sloan Kettering Cancer Center

🇺🇸

New York, New York, United States

NYP/Weill Cornell Medical Center

🇺🇸

New York, New York, United States

University of Rochester

🇺🇸

Rochester, New York, United States

Stony Brook University Medical Center

🇺🇸

Stony Brook, New York, United States

State University of New York Upstate Medical University

🇺🇸

Syracuse, New York, United States

New York Medical College

🇺🇸

Valhalla, New York, United States

Mission Hospital

🇺🇸

Asheville, North Carolina, United States

Carolinas Medical Center/Levine Cancer Institute

🇺🇸

Charlotte, North Carolina, United States

Novant Health Presbyterian Medical Center

🇺🇸

Charlotte, North Carolina, United States

Duke University Medical Center

🇺🇸

Durham, North Carolina, United States

East Carolina University

🇺🇸

Greenville, North Carolina, United States

Wake Forest University Health Sciences

🇺🇸

Winston-Salem, North Carolina, United States

Sanford Broadway Medical Center

🇺🇸

Fargo, North Dakota, United States

Children's Hospital Medical Center of Akron

🇺🇸

Akron, Ohio, United States

Cincinnati Children's Hospital Medical Center

🇺🇸

Cincinnati, Ohio, United States

Rainbow Babies and Childrens Hospital

🇺🇸

Cleveland, Ohio, United States

Cleveland Clinic Foundation

🇺🇸

Cleveland, Ohio, United States

Nationwide Children's Hospital

🇺🇸

Columbus, Ohio, United States

Dayton Children's Hospital

🇺🇸

Dayton, Ohio, United States

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

🇺🇸

Toledo, Ohio, United States

University of Oklahoma Health Sciences Center

🇺🇸

Oklahoma City, Oklahoma, United States

Legacy Emanuel Children's Hospital

🇺🇸

Portland, Oregon, United States

Oregon Health and Science University

🇺🇸

Portland, Oregon, United States

Lehigh Valley Hospital-Cedar Crest

🇺🇸

Allentown, Pennsylvania, United States

Geisinger Medical Center

🇺🇸

Danville, Pennsylvania, United States

Penn State Children's Hospital

🇺🇸

Hershey, Pennsylvania, United States

Children's Hospital of Philadelphia

🇺🇸

Philadelphia, Pennsylvania, United States

Saint Christopher's Hospital for Children

🇺🇸

Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh of UPMC

🇺🇸

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

🇺🇸

Providence, Rhode Island, United States

Medical University of South Carolina

🇺🇸

Charleston, South Carolina, United States

Prisma Health Richland Hospital

🇺🇸

Columbia, South Carolina, United States

BI-LO Charities Children's Cancer Center

🇺🇸

Greenville, South Carolina, United States

Sanford USD Medical Center - Sioux Falls

🇺🇸

Sioux Falls, South Dakota, United States

T C Thompson Children's Hospital

🇺🇸

Chattanooga, Tennessee, United States

East Tennessee Childrens Hospital

🇺🇸

Knoxville, Tennessee, United States

Saint Jude Children's Research Hospital

🇺🇸

Memphis, Tennessee, United States

The Children's Hospital at TriStar Centennial

🇺🇸

Nashville, Tennessee, United States

Vanderbilt University/Ingram Cancer Center

🇺🇸

Nashville, Tennessee, United States

Texas Tech University Health Sciences Center-Amarillo

🇺🇸

Amarillo, Texas, United States

Dell Children's Medical Center of Central Texas

🇺🇸

Austin, Texas, United States

Driscoll Children's Hospital

🇺🇸

Corpus Christi, Texas, United States

Medical City Dallas Hospital

🇺🇸

Dallas, Texas, United States

UT Southwestern/Simmons Cancer Center-Dallas

🇺🇸

Dallas, Texas, United States

El Paso Children's Hospital

🇺🇸

El Paso, Texas, United States

Cook Children's Medical Center

🇺🇸

Fort Worth, Texas, United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

🇺🇸

Houston, Texas, United States

M D Anderson Cancer Center

🇺🇸

Houston, Texas, United States

Covenant Children's Hospital

🇺🇸

Lubbock, Texas, United States

UMC Cancer Center / UMC Health System

🇺🇸

Lubbock, Texas, United States

Children's Hospital of San Antonio

🇺🇸

San Antonio, Texas, United States

Methodist Children's Hospital of South Texas

🇺🇸

San Antonio, Texas, United States

University of Texas Health Science Center at San Antonio

🇺🇸

San Antonio, Texas, United States

Primary Children's Hospital

🇺🇸

Salt Lake City, Utah, United States

University of Virginia Cancer Center

🇺🇸

Charlottesville, Virginia, United States

Inova Fairfax Hospital

🇺🇸

Falls Church, Virginia, United States

Children's Hospital of The King's Daughters

🇺🇸

Norfolk, Virginia, United States

Virginia Commonwealth University/Massey Cancer Center

🇺🇸

Richmond, Virginia, United States

Carilion Children's

🇺🇸

Roanoke, Virginia, United States

Seattle Children's Hospital

🇺🇸

Seattle, Washington, United States

Providence Sacred Heart Medical Center and Children's Hospital

🇺🇸

Spokane, Washington, United States

Mary Bridge Children's Hospital and Health Center

🇺🇸

Tacoma, Washington, United States

Madigan Army Medical Center

🇺🇸

Tacoma, Washington, United States

West Virginia University Charleston Division

🇺🇸

Charleston, West Virginia, United States

Edwards Comprehensive Cancer Center

🇺🇸

Huntington, West Virginia, United States

Saint Vincent Hospital Cancer Center Green Bay

🇺🇸

Green Bay, Wisconsin, United States

University of Wisconsin Carbone Cancer Center - University Hospital

🇺🇸

Madison, Wisconsin, United States

Marshfield Medical Center-Marshfield

🇺🇸

Marshfield, Wisconsin, United States

Children's Hospital of Wisconsin

🇺🇸

Milwaukee, Wisconsin, United States

John Hunter Children's Hospital

🇦🇺

Hunter Regional Mail Centre, New South Wales, Australia

Sydney Children's Hospital

🇦🇺

Randwick, New South Wales, Australia

The Children's Hospital at Westmead

🇦🇺

Westmead, New South Wales, Australia

Queensland Children's Hospital

🇦🇺

South Brisbane, Queensland, Australia

Women's and Children's Hospital-Adelaide

🇦🇺

North Adelaide, South Australia, Australia

Monash Medical Center-Clayton Campus

🇦🇺

Clayton, Victoria, Australia

Royal Children's Hospital

🇦🇺

Parkville, Victoria, Australia

Perth Children's Hospital

🇦🇺

Perth, Western Australia, Australia

Alberta Children's Hospital

🇨🇦

Calgary, Alberta, Canada

University of Alberta Hospital

🇨🇦

Edmonton, Alberta, Canada

British Columbia Children's Hospital

🇨🇦

Vancouver, British Columbia, Canada

CancerCare Manitoba

🇨🇦

Winnipeg, Manitoba, Canada

Janeway Child Health Centre

🇨🇦

Saint John's, Newfoundland and Labrador, Canada

IWK Health Centre

🇨🇦

Halifax, Nova Scotia, Canada

McMaster Children's Hospital at Hamilton Health Sciences

🇨🇦

Hamilton, Ontario, Canada

Children's Hospital

🇨🇦

London, Ontario, Canada

Children's Hospital of Eastern Ontario

🇨🇦

Ottawa, Ontario, Canada

Hospital for Sick Children

🇨🇦

Toronto, Ontario, Canada

The Montreal Children's Hospital of the MUHC

🇨🇦

Montreal, Quebec, Canada

Centre Hospitalier Universitaire Sainte-Justine

🇨🇦

Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

🇨🇦

Sherbrooke, Quebec, Canada

CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)

🇨🇦

Quebec, Canada

Starship Children's Hospital

🇳🇿

Grafton, Auckland, New Zealand

Christchurch Hospital

🇳🇿

Christchurch, New Zealand

HIMA San Pablo Oncologic Hospital

🇵🇷

Caguas, Puerto Rico

University Pediatric Hospital

🇵🇷

San Juan, Puerto Rico

King Faisal Specialist Hospital and Research Centre

🇸🇦

Riyadh, Saudi Arabia

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