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RecruitingNCT06647953Updated Aug 25, 2026

Testing a Standardized Approach to Surgery and Chemotherapy for Type I Pleuropulmonary Blastoma or the Addition of an Anti-cancer Drug, Topotecan, to the Usual Treatment for Types II and III Pleuropulmonary Blastoma

A Phase 3 interventional study of Biospecimen Collection and Biospecimen Collection in Pleuropulmonary Blastoma, sponsored by Children's Oncology Group. Recruiting at 87 sites in 2 countries. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2026-08-25.

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

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 6 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
110
Allocation
Non-randomized
Ages
Up to 21 Years
Sex
All
01

Study summary

This phase III trial tests how well surgery plus chemotherapy compared to surgery alone works in treating patients with type I pleuropulmonary blastoma (PPB), and tests how well surgery plus standard chemotherapy with the addition of topotecan works compared to surgery plus standard chemotherapy alone in treating patients with type II and III PPB.

Historically, most children with type I PPB had surgery and approximately 40% of children with type I PPB received chemotherapy following their surgery, usually for 22-42 weeks. There has not been a consistent standard for which children with type I PPB receive chemotherapy after surgery. For patients whose tumor has been removed completely with surgery, observation without chemotherapy may work as well as giving chemotherapy after surgery in preventing a return of the PPB tumor.

The standard chemotherapy for patients with types II or III PPB in the United States is four cycles of IVADo (ifosfamide, vincristine, dactinomycin, and doxorubicin) followed by 8 cycles of IVA (ifosfamide, vincristine and dactinomycin). Ifosfamide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of tumor cells in the body. Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy (antineoplastic antibiotic). It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. Topotecan is in a class of medications called topoisomerase I inhibitors. It works by interfering with tumor cell DNA which kills them. Giving topotecan in addition to standard IVADo and IVA chemotherapy regimens may shrink the cancer as well as or better than the standard therapy or could decrease the chance the tumor spreads while causing fewer side effects.

Read the detailed description

PRIMARY OBJECTIVE:

I. To determine the overall response rate (complete response [CR] + partial response [PR]) to 2 cycles of window therapy with vincristine, topotecan and cyclophosphamide in children with Types II and III pleuropulmonary blastoma (PPB) using Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

SECONDARY OBJECTIVES:

I. To estimate 3-year progression-free survival (PFS) and overall survival (OS) in children with Types II and III PPB.

II. To estimate 3-year PFS and OS in children with Type I PPB treated with surgery or surgery and chemotherapy using standardized guidelines.

EXPLORATORY OBJECTIVES:

I. To assess primary resection rate in children with Types I, II and III PPB using central radiology review and standardized surgical guidelines.

II. To assess surgical complications among those undergoing primary resection versus (vs.) biopsy followed by neoadjuvant chemotherapy for Types II and III PPB.

III. To establish a new cohort of prospectively treated children with newly diagnosed PPB which will serve as a comparison group for future novel agent trials.

IV. To evaluate toxicities in children treated for PPB including late cardiopulmonary toxicity.

V. To evaluate the molecular genetics/epigenetics of PPB and correlate with outcomes.

VI. To collect tumor tissue and serial blood samples for tumor profiling, liquid biopsies, and future correlative biology studies.

OUTLINE: Patients are assigned to 1 of 2 groups. For both groups, tumor tissue is centrally reviewed by a study pathologist. Blood samples are collected at specific clinical timepoints.

GROUP I (TYPE I/Ir PPB): Patients \< 5 years old with Type I PPB whose tumor was not able to be completely removed by surgery are assigned to Arm 1. All other patients are assigned to Arm 2.

ARM 1 (VAC1200/VA REGIMEN): Patients receive vincristine intravenously (IV) on days 1, 8, and 15 of cycles 1-3 and 5-7, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of each cycle, and cyclophosphamide IV over 30-60 minutes on day 1 of cycles 1-4. Cycles repeat every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, computed tomography (CT) and ultrasound throughout the study.

ARM 2: Patients undergo observation on study. This includes blood sample collection, chest CT, and ultrasound throughout the study.

GROUP II: (TYPE II/III PPB):

CYCLES 1-2 (VTC400 REGIMEN): Patients receive vincristine IV on days 1, 8, and 15 of each cycle, topotecan IV over 30 minutes on days 1-5 of each cycle, and cyclophosphamide IV over 15-30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo multi-gated acquisition (MUGA) or echocardiography (ECHO), positron emission tomography (PET) or bone scan, CT, magnetic resonance imaging (MRI), and blood sample collection throughout the study.

Patients with complete response, partial response, or stable disease after cycle 2 are assigned to Arm 3. Patients with disease progression after cycle 2 are assigned to Arm 4. Patients also undergo surgery and radiation therapy as clinically indicated.

ARM 3:

CYCLES 3-6 (IVADo REGIMEN): Patients receive vincristine IV on day 1 of each cycle, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of each cycle, ifosfamide IV over 3 hours on days 1-2 of each cycle, dexrazoxane IV over 5-15 minutes on days 1-2 of each cycle, and doxorubicin IV over 3-15 minutes on days 1-2 of each cycle. Cycles repeat every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

CYCLES 7, 9, 11 (VTC250 REGIMEN): Patients receive vincristine IV on days 1, 8, and 15 of each cycle, topotecan IV over 30 minutes on days 1-5 of each cycle, and cyclophosphamide IV over 15-30 minutes on days 1-5 of each cycle. Treatment continues for 21 days every odd cycle for 3 cycles in the absence of disease progression or unacceptable toxicity.

CYCLES 8, 10, 12 (VAC1200 REGIMEN): Patients receive vincristine IV on day 1 of each cycle, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of each cycle, and cyclophosphamide IV over 30-60 minutes on day 1 of each cycle. Treatment continues for 21 days every even cycle for 3 cycles in the absence of disease progression or unacceptable toxicity.

ARM 4:

CYCLES 3-6 (IVADo REGIMEN): Patients receive vincristine IV on day 1 of each cycle, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of each cycle, ifosfamide IV over 3 hours on days 1-2 of each cycle, dexrazoxane IV over 5-15 minutes on days 1-2 of each cycle, and doxorubicin IV over 3-15 minutes on days 1-2 of each cycle. Cycles repeat every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

CYCLES 7-12 (IVA REGIMEN): Patients receive vincristine IV on day 1 of each cycle, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of each cycle, and ifosfamide IV over 3 hours on day 1 of each cycle. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 24 months, then every 6 months until 5 years.

02

Conditions studied

  • Pleuropulmonary Blastoma
03

In context

Lead sponsor

Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 21 years of age or younger

  • Newly diagnosed PPB. Note that patients with known germline DICER1 variant or mosaicism with a large, solid unresectable thoracic mass with imaging features characteristic for Type II or III PPB are eligible without histologic confirmation of the diagnosis if a biopsy of the mass is not considered safe or feasible

    • Individuals are eligible based on institutional diagnosis of Type I, Ir, II or III PPB diagnosed within 60 days prior to enrollment. Children with Type II or III PPB at risk for clinical decompensation may receive protocol therapy while awaiting rapid central pathology review. Children with Type I or Ir PPB will be assigned to chemotherapy vs. observation based on imaging and central pathology review diagnosis. Type I and Ir patients should not begin chemotherapy prior to return of central pathology results

  • For patients with Type II or III PPB (within 7 days prior to enrollment): A serum creatinine based on age/sex as follows:

    • Age: 1 month to \< 6 months - Maximum Serum Creatinine (mg/dL): 0.4 (Male), 0.4 (Female)
    • Age: 6 months to \< 1 year - Maximum Serum Creatinine (mg/dL): 0.5 (Male), 0.5 (Female)
    • Age: 1 to \< 2 years - Maximum Serum Creatinine (mg/dL): 0.6 (Male), 0.6 (Female)
    • Age: 2 to \< 6 years - Maximum Serum Creatinine (mg/dL): 0.8 (Male), 0.8 (Female)
    • Age: 6 to \< 10 years - Maximum Serum Creatinine (mg/dL): 1 (Male), 1 (Female)
    • Age: 10 to \< 13 years - Maximum Serum Creatinine (mg/dL): 1.2 (Male), 1.2 (Female)
    • Age: 13 to \< 16 years - Maximum Serum Creatinine (mg/dL): 1.5 (Male), 1.4 (Female)
    • Age: ≥ 16 years - Maximum Serum Creatinine (mg/dL): 1.7 (Male), 1.4 (Female) OR - A 24 hour urine creatinine clearance ≥ 60 mL/min/1.73 m\^2 OR - A glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)
    • Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility
  • For patients with Type II or III PPB (within 7 days prior to enrollment): Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age

  • For patients with Type II or III PPB (within 7 days prior to enrollment): Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) ≤ 135 U/L

    • Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
  • Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% by radionuclide angiogram (within 21 days prior to start of protocol therapy)
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible as long as they are NOT receiving anti-retroviral agents that are strong inhibitors or inducers of CYP3A4

Exclusion criteria

Exclusion Criteria:

  • Administration of prior PPB-directed chemotherapy is an exclusion criterion. Prior treatment for another malignancy is not an exclusion criterion
  • Patients with known Charcot-Marie-Tooth disease
  • 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
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    Group I, Arm 1 (VAC1200/VA regimen)

    Patients receive vincristine IV on days 1, 8, and 15 of cycles 1-3 and 5-7, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of each cycle, and cyclophosphamide IV over 30-60 minutes on day 1 of cycles 1-4. Cycles repeat every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Tumor tissue is collected and centrally reviewed by a study pathologist. Patients also undergo blood sample collection, CT and ultrasound throughout the study.

    Procedure: Biospecimen Collection · Procedure: Computed Tomography · Drug: Cyclophosphamide · Biological: Dactinomycin · Procedure: Ultrasound Imaging · Drug: Vincristine

  • Active comparator
    Group I, Arm 2 (observation)

    Patients undergo observation on study. This includes tumor tissue collection and review by a study pathologist, and blood sample collection, chest CT, and ultrasound throughout the study.

    Procedure: Biospecimen Collection · Procedure: Computed Tomography · Other: Patient Observation · Procedure: Ultrasound Imaging

  • Experimental
    Group II, Arm 3 (VTC400, IVADo, VTC250, VAC1200 regimens)

    See Detailed Description for Group II, Arm 3.

    Procedure: Biospecimen Collection · Procedure: Bone Scan · Procedure: Computed Tomography · Drug: Cyclophosphamide · Biological: Dactinomycin · Drug: Dexrazoxane · Drug: Doxorubicin · Procedure: Echocardiography Test · Drug: Ifosfamide · Procedure: Magnetic Resonance Imaging · Procedure: Multigated Acquisition Scan · Procedure: Positron Emission Tomography · Drug: Topotecan · Drug: Vincristine

  • Experimental
    Group II, Arm 4 (VTC400, IVADo, IVA regimens)

    See Detailed Description for Group II, Arm 4.

    Procedure: Biospecimen Collection · Procedure: Bone Scan · Procedure: Computed Tomography · Drug: Cyclophosphamide · Biological: Dactinomycin · Drug: Dexrazoxane · Drug: Doxorubicin · Procedure: Echocardiography Test · Drug: Ifosfamide · Procedure: Magnetic Resonance Imaging · Procedure: Multigated Acquisition Scan · Procedure: Positron Emission Tomography · Drug: Topotecan · Drug: Vincristine

Interventions

  • ProcedureBiospecimen Collection

    Undergo collection of blood samples

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

  • ProcedureBiospecimen Collection

    Tumor tissue is collected and centrally reviewed by a study pathologist

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

  • ProcedureBone Scan

    Undergo bone scan

    Also known as: Bone Scintigraphy

  • ProcedureComputed Tomography

    Undergo CT

    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, 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

  • BiologicalDactinomycin

    Given IV

    Also known as: Actinomycin A IV, Actinomycin C1, Actinomycin D, Actinomycin I1, Actinomycin IV, Actinomycin X 1, Actinomycin-[thr-val-pro-sar-meval], Cosmegen, DACT, Dactinomycine, Lyovac Cosmegen, Meractinomycin

  • DrugDexrazoxane

    Given IV

    Also known as: 2, 6-Piperazinedione, 4,4'-propylenedi-, (P)- (8CI), 2,6-Piperazinedione, 4, 4'-(1-methyl-1,2-ethanediyl)bis-, (S)- (9CI), ADR 529, ADR-529, ADR529, ICRF 187, ICRF-187, ICRF187, Razoxane (+)-form, Soluble ICRF (L-isomer)

  • DrugDoxorubicin

    Given IV

    Also known as: Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin

  • ProcedureEchocardiography Test

    Undergo ECHO

    Also known as: EC, Echocardiography

  • DrugIfosfamide

    Given IV

    Also known as: Asta Z 4942, Asta Z-4942, Cyfos, Holoxan, Holoxane, Ifex, IFO, IFO-Cell, Ifolem, Ifomida, Ifomide, Ifosfamidum, Ifoxan, IFX, Iphosphamid, Iphosphamide, Iso-Endoxan, Isoendoxan, Isophosphamide, Mitoxana, MJF 9325, MJF-9325, Naxamide, Seromida, Tronoxal, Z 4942, Z-4942

  • 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

  • ProcedureMultigated Acquisition Scan

    Undergo MUGA

    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

  • OtherPatient Observation

    Undergo observation

    Also known as: Active Surveillance, deferred therapy, expectant management, Observation, Watchful Waiting

  • ProcedurePositron Emission Tomography

    Undergo PET

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

  • DrugTopotecan

    Given IV

    Also known as: Hycamptamine, Topotecan Lactone

  • ProcedureUltrasound Imaging

    Undergo ultrasound

    Also known as: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography, Ultrasound, Ultrasound Test, Ultrasound, Medical, US

  • DrugVincristine

    Given IV

    Also known as: LCR, Leurocristine, VCR, Vincrystine

06

What researchers measure

Primary outcomes

  1. Objective response

    Response rates at the end of Cycle 2 will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method. Any eligible type II/III patients who do not undergo complete resection, have measurable disease at baseline (per central review) and start protocol therapy will be included in the primary analysis.

    Time frame: Up to 2 cycles (cycles = 21 days) of window therapy with vincristine, topotecan and cyclophosphamide

Secondary outcomes

  1. Progression-free survival (PFS) in children with Types II and III pleuropulmonary blastoma (PPB)

    3-year PFS, along with the confidence intervals will be estimated using the Kaplan-Meier method. These results will be presented for Type II and III patients combined regardless of the timing of surgery.

    Time frame: From date of enrollment to the earliest occurrence of relapse, disease progression, or death due to any cause, assessed up to 3 years

  2. Overall survival (OS) in children with Types II and III PPB

    3-year OS, along with the confidence intervals will be estimated using the Kaplan-Meier method. These results will be presented for Type II and III patients combined regardless of the timing of surgery.

    Time frame: From date of enrollment to date of death due to any reason, assessed up to 3 years

  3. PFS in children with Types I PPB

    3-year PFS, along with the confidence intervals will be estimated using the Kaplan-Meier method.

    Time frame: From date of enrollment to the earliest occurrence of relapse, disease progression, or death due to any cause, assessed up to 3 years

  4. OS in children with Types I PPB

    3-year OS, along with the confidence intervals will be estimated using the Kaplan-Meier method.

    Time frame: From date of enrollment to date of death due to any reason, assessed up to 3 years

Other outcomes

  1. Resection rates for Type I PPB

    Will be reported based on central radiology reviews.

    Time frame: Prior to protocol therapy

  2. Resection rates for Type II and III PPB

    Will be reported based on central radiology reviews.

    Time frame: Prior to protocol therapy

  3. Resection rates for Type II and III PPB

    Will be reported based on central radiology reviews.

    Time frame: Prior to cycle 5 (cycles = 21 days)

  4. Incidence of surgery-related adverse events

    Percentage of patients with surgery related adverse event. Results will be summarized separately for those undergoing primary resection versus those undergoing biopsy followed by neoadjuvant chemotherapy.

    Time frame: Up to 5 years

  5. Incidence of adverse events

    Percentage of patients with Grade 3 or higher toxicities on protocol therapy.

    Time frame: Up to 36 weeks

  6. PFS

    Will use Kaplan-Meier survival curves and log-rank tests to analyze PFS based on DICER1 germline status, hotspot mutations, and p53 status. Additionally, Cox proportional hazards regression will be used to evaluate the influence of these genetic factors on PFS controlling for confounding variables as necessary.

    Time frame: Up to 5 years

  7. Primary outcome treatment effects by sex

    Estimates of the primary outcome treatment effect and the corresponding 95% confidence intervals (CIs) by sex will be provided.

    Time frame: Up to 5 years

  8. Primary outcome treatment effects by race

    Estimates of the primary outcome treatment effect and the corresponding 95% CIs by race will be provided.

    Time frame: Up to 5 years

  9. Primary outcome treatment effects by ethnicity

    Estimates of the primary outcome treatment effect and the corresponding 95% CIs by ethnicity will be provided.

    Time frame: Up to 5 years

07

Study locations

84 of 87 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
    • Alok K. Kothari · 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
    • Rachana Shah · Principal investigator
    Recruiting
  • Valley Children's Hospital
    Madera, California 93636, United States
    Recruiting
  • UCSF Benioff Children's Hospital Oakland
    Oakland, California 94609, United States
    • Site Public Contact · Contact · PedOncRschOAK@ucsf.edu · 510-428-3264
    • Arun A. Rangaswami · Principal investigator
    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
  • UCSF Medical Center-Mission Bay
    San Francisco, California 94158, United States
    • Site Public Contact · Contact · cancertrials@ucsf.edu · 877-827-3222
    • Arun A. Rangaswami · 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
  • 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
  • Nemours Children's Clinic-Jacksonville
    Jacksonville, Florida 32207, United States
    Recruiting
  • Nicklaus Children's Hospital
    Miami, Florida 33155, United States
    • Site Public Contact · Contact · 888-624-2778
    • Maggie E. Fader · Principal investigator
    Recruiting
  • Arnold Palmer Hospital for Children
    Orlando, Florida 32806, United States
    Recruiting
  • Nemours Children's Hospital
    Orlando, Florida 32827, United States
    Recruiting
  • Nemours Children's Clinic - Pensacola
    Pensacola, Florida 32504, 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
    • Blake Foxworthy · Principal investigator
    Recruiting
  • Saint Joseph's Hospital/Children's Hospital-Tampa
    Tampa, Florida 33607, United States
    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
    • Sarah G. Mitchell · 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 Chicago Comprehensive Cancer Center
    Chicago, Illinois 60637, United States
    Recruiting
  • Riley Hospital for Children
    Indianapolis, Indiana 46202, United States
    • Site Public Contact · Contact · 800-248-1199
    • Marissa Just · Principal investigator
    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
    Not yet recruiting
  • Norton Children's Hospital
    Louisville, Kentucky 40202, United States
    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
  • Johns Hopkins University/Sidney Kimmel Cancer Center
    Baltimore, Maryland 21287, United States
    • Site Public Contact · Contact · jhcccro@jhmi.edu · 410-955-8804
    • Lindy Zhang · Principal investigator
    Recruiting
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
    • Site Public Contact · Contact · 877-442-3324
    • Junne Kamihara · Principal investigator
    Recruiting
  • C S Mott Children's Hospital
    Ann Arbor, Michigan 48109, United States
    • Site Public Contact · Contact · 800-865-1125
    • Rama Jasty · Principal investigator
    Recruiting
  • Children's Hospital of Michigan
    Detroit, Michigan 48201, United States
    Recruiting
  • 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
  • Children's Hospitals and Clinics of Minnesota - Minneapolis
    Minneapolis, Minnesota 55404, United States
    Recruiting
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
    • Site Public Contact · Contact · 855-776-0015
    • Peter Schoettler · 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
  • 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
  • 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
  • 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
    • Scott Moerdler · Principal investigator
    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
  • Albany Medical Center
    Albany, New York 12208, United States
    • Site Public Contact · Contact · 518-262-5513
    • Lauren R. Weintraub · Principal investigator
    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
    • Carolyn F. Levy · 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
  • UNC Lineberger Comprehensive Cancer Center
    Chapel Hill, North Carolina 27599, United States
    Recruiting
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
    • Site Public Contact · Contact · 888-275-3853
    • Jessica M. Sun · Principal investigator
    Recruiting
  • Sanford Broadway Medical Center
    Fargo, North Dakota 58122, United States
    Recruiting
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
    • Site Public Contact · Contact · cancer@cchmc.org · 513-636-2799
    • Brian K. Turpin · Principal investigator
    Recruiting
  • Rainbow Babies and Childrens Hospital
    Cleveland, Ohio 44106, United States
    • Site Public Contact · Contact · 216-844-5437
    • Duncan S. Stearns · Principal investigator
    Recruiting
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
    Recruiting
  • Dayton Children's Hospital
    Dayton, Ohio 45404, United States
    • Site Public Contact · Contact · 800-228-4055
    • Jordan M. Wright · Principal investigator
    Recruiting
  • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
    Toledo, Ohio 43606, United States
    Recruiting
  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma 73104, United States
    Recruiting
  • Saint Francis Children's Hospital
    Tulsa, Oklahoma 74136, United States
    • Site Public Contact · Contact · 918-502-6720
    • Jill A. Salo · Principal investigator
    Recruiting
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
    • Site Public Contact · Contact · trials@ohsu.edu · 503-494-1080
    • Katrina Winsnes · Principal investigator
    Not yet recruiting
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
    Recruiting
  • Children's Hospital of Pittsburgh of UPMC
    Pittsburgh, Pennsylvania 15224, United States
    • Site Public Contact · Contact · jean.tersak@chp.edu · 412-692-8570
    • Brittani K. Seynnaeve · Principal investigator
    Recruiting
  • BI-LO Charities Children's Cancer Center
    Greenville, South Carolina 29605, United States
    Recruiting
  • Sanford USD Medical Center - Sioux Falls
    Sioux Falls, South Dakota 57117-5134, United States
    Recruiting
  • Saint Jude Children's Research Hospital
    Memphis, Tennessee 38105, United States
    • Site Public Contact · Contact · referralinfo@stjude.org · 888-226-4343
    • Alberto S. Pappo · Principal investigator
    Recruiting
  • The Children's Hospital at TriStar Centennial
    Nashville, Tennessee 37203, United States
    • Site Public Contact · Contact · 615-342-1919
    • Clinton M. Carroll · Principal investigator
    Recruiting
  • Vanderbilt University/Ingram Cancer Center
    Nashville, Tennessee 37232, United States
    • Site Public Contact · Contact · 800-811-8480
    • Daniel J. Benedetti · Principal investigator
    Recruiting
  • Dell Children's Medical Center of Central Texas
    Austin, Texas 78723, United States
    Recruiting
  • UT Southwestern/Simmons Cancer Center-Dallas
    Dallas, Texas 75390, United States
    Recruiting
  • Cook Children's Medical Center
    Fort Worth, Texas 76104, United States
    Recruiting
  • Covenant Children's Hospital
    Lubbock, Texas 79410, United States
    • Site Public Contact · Contact · mbisbee@providence.org · 806-725-8657
    • Kishor M. Bhende · Principal investigator
    Recruiting
  • Children's Hospital of San Antonio
    San Antonio, Texas 78207, United States
    Recruiting
  • Methodist Children's Hospital of South Texas
    San Antonio, Texas 78229, United States
    Recruiting
  • Primary Children's Hospital
    Salt Lake City, Utah 84113, United States
    • Site Public Contact · Contact · 801-585-5270
    • Matthew Dietz · Principal investigator
    Recruiting
  • University of Virginia Cancer Center
    Charlottesville, Virginia 22908, United States
    Recruiting
  • Children's Hospital of The King's Daughters
    Norfolk, Virginia 23507, United States
    • Site Public Contact · Contact · CCBDCresearch@chkd.org · 757-668-7243
    • Melissa S. Mark · Principal investigator
    Recruiting
  • Seattle Children's Hospital
    Seattle, Washington 98105, United States
    • Site Public Contact · Contact · 866-987-2000
    • Sarah E. Leary · Principal investigator
    Not yet recruiting
  • Providence Sacred Heart Medical Center and Children's Hospital
    Spokane, Washington 99204, United States
    Recruiting
  • Saint Vincent Hospital Cancer Center Green Bay
    Green Bay, Wisconsin 54301, United States
    Recruiting
  • University of Wisconsin Carbone Cancer Center - University Hospital
    Madison, Wisconsin 53792, United States
    Recruiting
  • CancerCare Manitoba
    Winnipeg, Manitoba R3E 0V9, Canada
    • Site Public Contact · Contact · ctu_web@cancercare.mb.ca · 866-561-1026
    • Stephanie M. Villeneuve · Principal investigator
    Recruiting
  • IWK Health Centre
    Halifax, Nova Scotia B3K 6R8, Canada
    Recruiting
  • Hospital for Sick Children
    Toronto, Ontario M5G 1X8, Canada
    • Site Public Contact · Contact · ask.CRS@sickkids.ca · 416-813-7654
    • David Malkin · Principal investigator
    Recruiting
  • The Montreal Children's Hospital of the MUHC
    Montreal, Quebec H3H 1P3, Canada
    • Site Public Contact · Contact · info@thechildren.com · 514-412-4445
    • Stephanie Mourad · Principal investigator
    Recruiting
  • Centre Hospitalier Universitaire Sainte-Justine
    Montreal, Quebec H3T 1C5, Canada
    Recruiting
  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
    Sherbrooke, Quebec J1H 5N4, Canada
    Recruiting
  • CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
    Québec, G1V 4G2, Canada
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06647953
Lead sponsor
Children's Oncology Group
Responsible party
Sponsor
First posted
Oct 18, 2024
Start date
Mar 21, 2025
Primary completion
Mar 31, 2029 (estimated)
Completion
Mar 31, 2029 (estimated)
Last update
Aug 25, 2026

Study contacts

Kris Ann P Schultz
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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