RecruitingInterventionalPhase 2

Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

NCT ID: NCT04322318Sponsor: Children's Oncology GroupLast updated: 2026-05-05

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.

Arms & interventions

ProcedureBiopsy Procedure
Undergo a biopsy
ProcedureBiospecimen Collection
Undergo blood sample collection
ProcedureBone Scan
Undergo a bone scan
DrugCarboplatin
Given IV
ProcedureComputed Tomography
Undergo a CT scan
DrugCyclophosphamide
Given IV
DrugDoxorubicin
Given IV
DrugEtoposide
Given IV
DrugIfosfamide
Given IV
DrugIrinotecan
Given IV
ProcedureMagnetic Resonance Imaging
Undergo MRI
ProcedurePositron Emission Tomography
Undergo a PET scan
RadiationRadiation Therapy
Undergo RT
ProcedureSurgical Procedure
Undergo surgery
DrugTopotecan
Given IV
ProcedureTransabdominal Ultrasound
Undergo abdominal ultrasound
DrugVincristine
Given IV
ProcedureX-Ray Imaging
Undergo a chest x-ray

Outcome measures

Primary

Event-free survival (EFS) for stratum 1-3
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.
Time frame: From 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
EFS for stratum 4
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.
Time frame: From 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

Secondary

Overall survival (OS) for stratum 1-4
Time frame: From study entry to death due to any cause, assessed up to 5 years from study entry

Eligibility criteria

Sex: AllAge: Up to 30 YearsHealthy volunteers: No

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 locations (177)

Children's Hospital of Alabama

Birmingham, Alabama, 35233

Recruiting

Site Public Contact · Contact

205-638-9285 oncologyresearch@peds.uab.edu

Elizabeth D. Alva · Principal Investigator

USA Health Strada Patient Care Center

Mobile, Alabama, 36604

Recruiting

Site Public Contact · Contact

800-388-8721

Hamayun Imran · Principal Investigator

Providence Alaska Medical Center

Anchorage, Alaska, 99508

Recruiting

Site Public Contact · Contact

907-212-6871 AKPAMC.OncologyResearchSupport@providence.org

Brenda J. Wittman · Principal Investigator

Banner Children's at Desert

Mesa, Arizona, 85202

Recruiting

Site Public Contact · Contact

480-412-3100

Joseph C. Torkildson · Principal Investigator

Phoenix Childrens Hospital

Phoenix, Arizona, 85016

Recruiting

Site Public Contact · Contact

602-546-0920

Alok K. Kothari · Principal Investigator

Banner University Medical Center - Tucson

Tucson, Arizona, 85719

Recruiting

Site Public Contact · Contact

UACC-IIT@uacc.arizona.edu

Michelina de la Maza · Principal Investigator

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591

Recruiting

Site Public Contact · Contact

501-364-7373

Michael W. Bishop · Principal Investigator

Kaiser Permanente Downey Medical Center

Downey, California, 90242

Recruiting

Site Public Contact · Contact

626-564-3455

Neha G. Vaghasia · Principal Investigator

Loma Linda University Medical Center

Loma Linda, California, 92354

Recruiting

Site Public Contact · Contact

909-558-4050

Albert Kheradpour · Principal Investigator

Miller Children's and Women's Hospital Long Beach

Long Beach, California, 90806

Recruiting

Site Public Contact · Contact

562-933-5600

Jacqueline N. Casillas · Principal Investigator

Children's Hospital Los Angeles

Los Angeles, California, 90027

Recruiting

Site Public Contact · Contact

323-361-4110

Rachana Shah · Principal Investigator

Cedars-Sinai Medical Center

Los Angeles, California, 90048

Recruiting

Site Public Contact · Contact

310-423-2133 Cancer.trial.info@cshs.org

Leo Mascarenhas · Principal Investigator

Mattel Children's Hospital UCLA

Los Angeles, California, 90095

Recruiting

Site Public Contact · Contact

310-825-6708

Satiro N. De Oliveira · Principal Investigator

Valley Children's Hospital

Madera, California, 93636

Recruiting

Site Public Contact · Contact

559-353-3000 Research@valleychildrens.org

Ruetima Titapiwatanakun · Principal Investigator

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609

Recruiting

Site Public Contact · Contact

510-428-3264 PedOncRschOAK@ucsf.edu

Jennifer G. Michlitsch · Principal Investigator

Kaiser Permanente-Oakland

Oakland, California, 94611

Recruiting

Site Public Contact · Contact

877-642-4691 Kpoct@kp.org

Aarati V. Rao · Principal Investigator

Children's Hospital of Orange County

Orange, California, 92868

Recruiting

Site Public Contact · Contact

714-509-8646 oncresearch@choc.org

Elyssa M. Rubin · Principal Investigator

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, 94304

Recruiting

Site Public Contact · Contact

800-694-0012 ccto-office@stanford.edu

Jay Michael S. Balagtas · Principal Investigator

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817

Recruiting

Site Public Contact · Contact

916-734-3089

Marcio H. Malogolowkin · Principal Investigator

Rady Children's Hospital - San Diego

San Diego, California, 92123

Recruiting

Site Public Contact · Contact

858-966-5934

William D. Roberts · Principal Investigator

UCSF Medical Center-Mission Bay

San Francisco, California, 94158

Recruiting

Site Public Contact · Contact

877-827-3222 cancertrials@ucsf.edu

Arun A. Rangaswami · Principal Investigator

Children's Hospital Colorado

Aurora, Colorado, 80045

Recruiting

Site Public Contact · Contact

303-764-5056 josh.b.gordon@nsmtp.kp.org

Timothy P. Garrington · Principal Investigator

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

Denver, Colorado, 80218

Recruiting

Site Public Contact · Contact

303-832-2344 PSGResearchSharedMailbox@HCAHealthcare.com

Florence Choo · Principal Investigator

Connecticut Children's Medical Center

Hartford, Connecticut, 06106

Recruiting

Site Public Contact · Contact

860-545-9981

Michael S. Isakoff · Principal Investigator

Yale University

New Haven, Connecticut, 06520

Recruiting

Site Public Contact · Contact

203-785-5702 canceranswers@yale.edu

Farzana Pashankar · Principal Investigator

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803

Recruiting

Site Public Contact · Contact

302-651-5572 Allison.bruce@nemours.org

Vibhuti Agarwal · Principal Investigator

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007

Recruiting

Site Public Contact · Contact

202-444-2223

Caileigh Pudela · Principal Investigator

Children's National Medical Center

Washington D.C., District of Columbia, 20010

Recruiting

Site Public Contact · Contact

202-476-2800 OncCRC_OnCall@childrensnational.org

Jeffrey S. Dome · Principal Investigator

Broward Health Medical Center

Fort Lauderdale, Florida, 33316

Recruiting

Site Public Contact · Contact

302-651-5572 Allison.bruce@nemours.org

Hector M. Rodriguez-Cortes · Principal Investigator

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908

Recruiting

Site Public Contact · Contact

239-343-5333 molly.arnstrom@leehealth.org

Emad K. Salman · Principal Investigator

UF Health Cancer Institute - Gainesville

Gainesville, Florida, 32610

Recruiting

Site Public Contact · Contact

352-273-8010 cancer-center@ufl.edu

Brian Stover · Principal Investigator

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021

Recruiting

Site Public Contact · Contact

954-265-1847 OHR@mhs.net

Iftikhar Hanif · Principal Investigator

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207

Recruiting

Site Public Contact · Contact

302-651-5572 Allison.bruce@nemours.org

Vibhuti Agarwal · Principal Investigator

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136

Recruiting

Site Public Contact · Contact

305-243-2647

Meghan McCormick · Principal Investigator

Nicklaus Children's Hospital

Miami, Florida, 33155

Recruiting

Site Public Contact · Contact

888-624-2778

Maggie E. Fader · Principal Investigator

Arnold Palmer Hospital for Children

Orlando, Florida, 32806

Recruiting

Site Public Contact · Contact

321-841-5357 Jennifer.spinelli@orlandohealth.com

Jaime M. Libes-Bander · Principal Investigator

Nemours Children's Hospital

Orlando, Florida, 32827

Recruiting

Site Public Contact · Contact

302-651-5572 Allison.bruce@nemours.org

Vibhuti Agarwal · Principal Investigator

Nemours Children's Clinic - Pensacola

Pensacola, Florida, 32504

Recruiting

Site Public Contact · Contact

helpdesk@childrensoncologygroup.org

Jeffrey H. Schwartz · Principal Investigator

Sacred Heart Hospital

Pensacola, Florida, 32504

Suspended

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701

Recruiting

Site Public Contact · Contact

727-767-4784 Ashley.Repp@jhmi.edu

Jennifer B. Dean · Principal Investigator

Tampa General Hospital

Tampa, Florida, 33606

Recruiting

Site Public Contact · Contact

813-844-7829 syapchanyk@tgh.org

Andrew J. Galligan · Principal Investigator

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

Tampa, Florida, 33607

Recruiting

Site Public Contact · Contact

813-357-0849 jennifer.manns@baycare.org

Don E. Eslin · Principal Investigator

Saint Mary's Medical Center

West Palm Beach, Florida, 33407

Recruiting

Site Public Contact · Contact

561-822-4745

Matthew D. Ramirez · Principal Investigator

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, 30329

Recruiting

Site Public Contact · Contact

404-785-0232 Olivia.Floyd@choa.org

Andrew L. Hong · Principal Investigator

Augusta University Medical Center

Augusta, Georgia, 30912

Recruiting

Site Public Contact · Contact

706-721-2388 ga_cares@augusta.edu

Colleen H. McDonough · Principal Investigator

Atrium Health Navicent

Macon, Georgia, 31201

Recruiting

Site Public Contact · Contact

478-633-2152 andrew.weatherall@atriumhealth.org

Sushmita Nair · Principal Investigator

Memorial Health University Medical Center

Savannah, Georgia, 31404

Recruiting

Site Public Contact · Contact

912-350-7887 Lorraine.OHara@hcahealthcare.com

Andrew L. Pendleton · Principal Investigator

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826

Recruiting

Site Public Contact · Contact

808-983-6090

Wade T. Kyono · Principal Investigator

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712

Recruiting

Site Public Contact · Contact

208-381-2774 eslinget@slhs.org

Martha M. Pacheco · Principal Investigator

Lurie Children's Hospital-Chicago

Chicago, Illinois, 60611

Recruiting

Site Public Contact · Contact

773-880-4562

Amy L. Walz · Principal Investigator

University of Illinois

Chicago, Illinois, 60612

Active Not Recruiting

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637

Recruiting

Site Public Contact · Contact

773-702-8222 cancerclinicaltrials@bsd.uchicago.edu

Ami V. Desai · Principal Investigator

Loyola University Medical Center

Maywood, Illinois, 60153

Recruiting

Site Public Contact · Contact

708-226-4357

Eugene Suh · Principal Investigator

Advocate Children's Hospital-Oak Lawn

Oak Lawn, Illinois, 60453

Recruiting

Site Public Contact · Contact

847-723-7570

Rebecca E. McFall · Principal Investigator

Advocate Children's Hospital-Park Ridge

Park Ridge, Illinois, 60068

Recruiting

Site Public Contact · Contact

helpdesk@childrensoncologygroup.org

Rebecca E. McFall · Principal Investigator

Saint Jude Midwest Affiliate

Peoria, Illinois, 61637

Recruiting

Site Public Contact · Contact

888-226-4343

Prerna Kumar · Principal Investigator

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

Recruiting

Site Public Contact · Contact

217-545-7929

Gregory P. Brandt · Principal Investigator

Riley Hospital for Children

Indianapolis, Indiana, 46202

Recruiting

Site Public Contact · Contact

800-248-1199

Marissa Just · Principal Investigator

Ascension Saint Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260

Recruiting

Site Public Contact · Contact

317-338-2194 research@stvincent.org

Bassem I. Razzouk · Principal Investigator

Blank Children's Hospital

Des Moines, Iowa, 50309

Recruiting

Site Public Contact · Contact

515-241-8912 samantha.mallory@unitypoint.org

Samantha L. Mallory · Principal Investigator

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242

Recruiting

Site Public Contact · Contact

800-237-1225

Andrew P. Groves · Principal Investigator

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536

Recruiting

Site Public Contact · Contact

859-257-3379

James T. Badgett · Principal Investigator

Norton Children's Hospital

Louisville, Kentucky, 40202

Recruiting

Site Public Contact · Contact

502-629-5500 CancerResource@nortonhealthcare.org

Michael J. Ferguson · Principal Investigator

Children's Hospital New Orleans

New Orleans, Louisiana, 70118

Recruiting

Site Public Contact · Contact

504-894-5377

Maria C. Velez-Yanguas · Principal Investigator

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121

Active Not Recruiting

Eastern Maine Medical Center

Bangor, Maine, 04401

Recruiting

Site Public Contact · Contact

207-973-4274

Daniel L. Callaway · Principal Investigator

Maine Children's Cancer Program

Scarborough, Maine, 04074

Recruiting

Site Public Contact · Contact

207-396-8670 clinicalresearch@mainehealth.org

Aaron R. Weiss · Principal Investigator

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215

Recruiting

Site Public Contact · Contact

410-601-9083

Jason M. Fixler · Principal Investigator

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287

Recruiting

Site Public Contact · Contact

410-955-8804 jhcccro@jhmi.edu

Alan D. Friedman · Principal Investigator

Tufts Children's Hospital

Boston, Massachusetts, 02111

Active Not Recruiting

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting

Site Public Contact · Contact

877-442-3324

Elizabeth A. Mullen · Principal Investigator

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655

Recruiting

Site Public Contact · Contact

508-856-3216 cancer.research@umassmed.edu

Stefanie R. Lowas · Principal Investigator

C S Mott Children's Hospital

Ann Arbor, Michigan, 48109

Recruiting

Site Public Contact · Contact

800-865-1125

Rama Jasty · Principal Investigator

Children's Hospital of Michigan

Detroit, Michigan, 48201

Recruiting

Site Public Contact · Contact

helpdesk@childrensoncologygroup.org

Alissa M. Martin · Principal Investigator

Michigan State University

East Lansing, Michigan, 48823

Suspended

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

Grand Rapids, Michigan, 49503

Recruiting

Site Public Contact · Contact

616-391-1230 crcwm-regulatory@crcwm.org

Kathleen Y. Butler · Principal Investigator

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007

Recruiting

Site Public Contact · Contact

616-391-1230 crcwm-regulatory@crcwm.org

Kathleen Y. Butler · Principal Investigator

Corewell Health Children's

Royal Oak, Michigan, 48073

Recruiting

Site Public Contact · Contact

248-551-7695

Marie V. Nelson · Principal Investigator

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404

Recruiting

Site Public Contact · Contact

612-813-5913 pauline.mitby@childrensmn.org

Michael K. Richards · Principal Investigator

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455

Recruiting

Site Public Contact · Contact

612-624-2620

Robin L. Williams · Principal Investigator

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Recruiting

Site Public Contact · Contact

855-776-0015

Wendy Allen-Rhoades · Principal Investigator

University of Mississippi Medical Center

Jackson, Mississippi, 39216

Recruiting

Site Public Contact · Contact

601-815-6700

Betty L. Herrington · Principal Investigator

University of Missouri Children's Hospital

Columbia, Missouri, 65212

Recruiting

Site Public Contact · Contact

573-882-1960 snwq62@health.missouri.edu

Barbara A. Gruner · Principal Investigator

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108

Recruiting

Site Public Contact · Contact

816-302-6808 COGResearchGroup@cmh.edu

Keith J. August · Principal Investigator

Cardinal Glennon Children's Medical Center

St Louis, Missouri, 63104

Recruiting

Site Public Contact · Contact

314-268-4000

William S. Ferguson · Principal Investigator

Washington University School of Medicine

St Louis, Missouri, 63110

Recruiting

Site Public Contact · Contact

800-600-3606 info@siteman.wustl.edu

Amy Armstrong · Principal Investigator

Mercy Hospital Saint Louis

St Louis, Missouri, 63141

Recruiting

Site Public Contact · Contact

314-251-7066

Robin D. Hanson · Principal Investigator

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, 68114

Recruiting

Site Public Contact · Contact

402-955-3949

Jill C. Beck · Principal Investigator

University of Nebraska Medical Center

Omaha, Nebraska, 68198

Recruiting

Site Public Contact · Contact

402-559-6941 unmcrsa@unmc.edu

Jill C. Beck · Principal Investigator

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102

Recruiting

Site Public Contact · Contact

702-384-0013 research@sncrf.org