RecruitingInterventionalPhase 2

A Phase 2 Trial of Chemotherapy Followed by Response-Based Whole Ventricular &Amp; Spinal Canal Irradiation (WVSCI) for Patients With Localized Non-Germinomatous Central Nervous System Germ Cell Tumor

NCT ID: NCT04684368Sponsor: Children's Oncology GroupLast updated: 2026-05-05

Summary

This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) based on the patient's response to induction chemotherapy in patients with non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the brain or body (localized). This study has 2 goals: 1) optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses, 2) utilizing higher dose chemotherapy followed by conventional RT in patients who did not respond to induction chemotherapy. Chemotherapy drugs, such as carboplatin, etoposide, ifosfamide, and thiotepa, 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. Radiation therapy uses high energy x-rays or high-energy protons to kill tumor cells and shrink tumors. Studies have shown that patients with newly-diagnosed localized NGGCT, whose disease responds well to chemotherapy before receiving radiation therapy, are more likely to be free of the disease for a longer time than are patients for whom the chemotherapy does not efficiently eliminate or reduce the size of the tumor. The purpose of this study is to see how well the tumors respond to induction chemotherapy to decide what treatment to give next. Some patients will be given RT to the spine and a portion of the brain. Others will be given high dose chemotherapy and a stem cell transplant before RT to the whole brain and spine. Giving treatment based on the response to induction chemotherapy may lower the side effects of radiation in some patients and adjust the therapy to a more efficient one for other patients with localized NGGCT.

Detailed description

PRIMARY OBJECTIVES: I. To monitor outcome to ensure that children and young adults with localized central nervous system (CNS) non-germinomatous germ cell tumors (NGGCT) treated with induction chemotherapy followed by response evaluation and whole ventricular + spinal canal irradiation (WVSCI) will maintain the excellent 2-year progression free survival (PFS) rate as compared to ACNS0122 (NCT00047320). II. To improve disease control by decreasing the number of spinal relapses for patients who achieve a complete response (CR) or partial response (PR) and receive WVSCI as compared to whole ventricular radiation on ACNS1123 (NCT01602666). SECONDARY OBJECTIVES: I. To estimate the response rates to induction chemotherapy and WVSCI for localized NGGCT patients who achieve a CR/PR. II. To estimate the PFS and overall survival (OS) for localized NGGCT patients who achieve a CR/PR and receive WVSCI. III. To estimate the PFS and OS for patients with less than a CR/PR following Induction who subsequently receive high-dose chemotherapy with peripheral stem cell rescue (HDCSCR). IV. To estimate the response rate for patients with less than a CR/PR following Induction who subsequently receive HDCSCR. EXPLORATORY OBJECTIVES: I. To prospectively compare outcomes based on radiation modality, photon versus proton, including cognitive, social and behavioral functioning, auditory, and neuro-endocrine function. II. To compare spinal column growth and cell counts following radiation as measured by height and weight, and complete blood count (CBC) values during and after radiation therapy, based on treatment modality (photon versus \[vs.\] proton therapy) and planned inclusion/exclusion of the vertebral body in patients \< 13 years of age. III. To compare local vs. central review recommendations for second-look surgery and document barriers for performing such surgeries as well as their clinical benefit in pediatric NGGCT. IV. To prospectively evaluate and longitudinally model the cognitive, social, and behavioral functioning of children and young adults with localized CNS NGGCT with testing as per the Children's Oncology Group (COG) Standardized Neuropsychological and Behavioral Battery. V. To evaluate patterns of disease recurrence/failure with respect to radiation dose distribution. OUTLINE: INDUCTION CHEMOTHERAPY: Patients receive carboplatin intravenously (IV) over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of cycles 1, 3, and 5. Patients also receive ifosfamide IV over 60 minutes and etoposide IV over 60-120 minutes on days 1-5 of cycles 2, 4, and 6. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients are assigned to 1 of 2 plans (ventricular + spinal canal irradiation \[WVSCI\] or high-dose chemotherapy with peripheral stem cell rescue \[HDCSCR\]) based on response to induction chemotherapy: * Patients who achieve radiographic CR/PR with marker normalization proceed to WVSCI. Patients who achieve radiographic CR without marker normalization proceed to HDCSCR. * Patients who achieve less than radiographic CR/PR with marker normalization proceed to second-look surgery (unless contraindicated). If second-look surgery reveals mature teratoma or non-viable tumor, proceed to WVSCI. If second-look surgery reveals viable tumor, proceed to HDCSCR. Patients who are unable to undergo second-look surgery are removed from protocol therapy but remain on study for follow-up. * Patients who achieve less than radiographic CR/PR without marker normalization proceed to second-look surgery (unless contraindicated). Patients then proceed to HDCSCR regardless of whether or not a second-look surgery is performed. * Patients who achieve radiographic PR without marker normalization proceed to second-look surgery (unless contraindicated). Patients then proceed to HDCSCR regardless of whether or not a second-look surgery is performed. PLAN A (WVSCI THERAPY): Within 6 weeks of the end of induction chemotherapy or second-look surgery, patients undergo WVSCI once daily (QD) for 5 days weekly (17 fractions followed by a boost dose for 13 fractions) for 6 weeks in the absence of disease progression or unacceptable toxicity. PLAN B (CONSOLIDATION THERAPY \[HDCSCR\]): Within 6-8 weeks of the end of induction chemotherapy or second-look surgery, patients receive etoposide IV and thiotepa IV over 3 hours on days -5 to -3 and undergo peripheral blood stem cell (PBSC) transplant on day 0. Patients then undergo radiation therapy QD for 5 days weekly (20 fractions followed by a boost dose for 10 fractions) for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo magnetic resonance imaging (MRI), as well as collection of cerebral spinal fluid (CSF) and blood sample throughout the trial. After completion of study treatment, patients are followed for up to 10 years.

Arms & interventions

ProcedureBiospecimen Collection
Undergo collection of CSF and blood samples
DrugCarboplatin
Given IV
DrugEtoposide
Given IV
BiologicalFilgrastim
Given subcutaneously (SC) or IV
DrugIfosfamide
Given IV
ProcedureMagnetic Resonance Imaging
Undergo MRI
DrugMesna
Given IV or orally
BiologicalPegfilgrastim
Given SC
ProcedurePeripheral Blood Stem Cell Transplantation
Undergo PBSC transplant
OtherQuestionnaire Administration
Ancillary studies
RadiationRadiation Therapy
Undergo WVSCI radiation therapy
RadiationRadiation Therapy
Undergo radiation therapy
ProcedureSecond-Look Surgery
Undergo second-look surgery if needed
DrugThiotepa
Given IV

Outcome measures

Primary

Failure rate
Will be measured by the number of progressions or deaths within 2 years of enrollment for the cohort treated with whole ventricular + spinal canal irradiation (WVSCI). The final analysis will include an exact binomial confidence interval of the failure rate for each of the failure types (local, distant/spinal or both) without adjustment for multiplicity.
Time frame: Within 2 years of enrollment
Spinal failure rate
Will be measured by the number of spinal relapses (spine alone or distant relapses including the spine) within 2 years of enrollment in patients treated with WVSCI. The final analysis will include an exact binomial confidence interval of spinal failure rate.
Time frame: Within 2 years of enrollment

Secondary

Radiographic complete response (CR)/partial response (PR) with marker normalization rate post induction/second-look surgery
Time frame: Approximately 6 to 9 months post-treatment initiation
Radiographic complete response (CR)/partial response (PR) with marker normalization rate post high-dose chemotherapy with peripheral stem cell rescue (HDCSCR)
Time frame: Up to 2 years post-treatment initiation
Progression-free survival (PFS)
Time frame: From enrollment until disease progression or death from any cause for patients with events, and until final follow up for those who are event free at the time of analysis, assessed up to 10 years
Overall survival (OS)
Time frame: From enrollment until death from any cause for patients with events and until final follow up for those who are alive at the time of analysis, assessed up to 10 years
Patterns of disease recurrence/failure
Time frame: Up to 10 years

Eligibility criteria

Sex: AllAge: 3 Years to 29 YearsHealthy volunteers: No

Inclusion Criteria: * Patients must be \>= 3 years and \< 30 years at the time of study enrollment * Patients must be newly diagnosed with localized primary CNS NGGCT of the suprasellar and/or pineal region by pathology and/or serum or cerebrospinal fluid (CSF) elevation of AFP above institutional normal or \> 10 ng/mL or human chorionic gonadotropin (hCG) beta \> 100 mIU/mL as confirmed by Rapid Central Marker Screening Review on APEC14B1-CNS. Suprasellar, pineal and bifocal tumors are included. (CSF tumor markers and cytology must be within 31 days prior to enrollment and start of protocol therapy \[repeat if necessary\]. Serum tumor markers, AFP and hCGbeta must be within 7 days prior to enrollment and start of protocol therapy \[repeat if necessary\]). Basal ganglia or other primary sites are excluded * Patients with any of the following pathological elements are eligible: endodermal sinus (yolk sac), embryonal carcinoma, choriocarcinoma, malignant/immature teratoma and mixed germ cell tumor (GCT) (i.e., may include some pure germinoma) if malignant elements listed above are present. Patients with only mature teratoma are excluded. Patients with pure germinoma admixed with mature teratoma are excluded (would be eligible for pure germinoma protocols) * Patients must have a cranial MRI with and without gadolinium at diagnosis/prior to enrollment. If surgical resection is performed, patients must have pre-operative and post operative brain MRI with and without gadolinium. The post operative brain MRI should be obtained within 72 hours of surgery. If patient has a biopsy only, post-operative brain MRI is recommended but not required (within 31 days prior to study enrollment and start of protocol therapy ) * Patients must have a spine MRI with gadolinium obtained at diagnosis/prior to enrollment. Spine MRI with and without gadolinium is recommended (within 31 days prior to study enrollment and start of protocol therapy) * Lumbar CSF must be obtained prior to study enrollment unless medically contraindicated. If a patient undergoes surgery and lumbar CSF cytology cannot be obtained at the time of surgery, then it should be performed at least 10 days following surgery and prior to study enrollment. False positive cytology can occur within 10 days of surgery * Patients must have RAPID CENTRAL TUMOR MARKER REVIEW CSF tumor markers obtained prior to enrollment unless medically contraindicated. Ventricular CSF obtained at the time of CSF diversion procedure (if performed) is acceptable for tumor markers but lumbar CSF is preferred. In case CSF diversion and biopsy/surgery are combined, CSF tumor markers should be collected first * Peripheral absolute neutrophil count (ANC) \>= 1000/uL (within 7 days prior to enrollment) * Platelet count \>= 100,000/uL (transfusion independent) (within 7 days prior to enrollment) * Hemoglobin \>= 8.0 g/dL (may receive red blood cell \[RBC\] transfusions) (within 7 days prior to enrollment) * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or a serum creatinine based on age/gender as follows (within 7 days prior to enrollment): * Age: Maximum serum creatinine (mg/dL) * 3 to \< 6 years: 0.8 (male), 0.8 (female) * 6 to \< 10 years: 1 (male), 1 (female) * 10 to \< 13 years: 1.2 (male), 1.2 (female) * 13 to \< 16 years: 1.5 (male), 1.4 (female) * \>= 16 years: male (1.7), 1.4 (female) * Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment) * Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L (within 7 days prior to enrollment) * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L * Central nervous system function defined as: * Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled * Patients must not be in status epilepticus, coma or assisted ventilation prior to study enrollment * Protocol therapy must begin within 31 calendar days of definitive surgery or clinical diagnosis, whichever is later. If a biopsy only was performed, the biopsy date will be considered the date of definitive surgery. For patients who have a biopsy or incomplete resection at diagnosis followed by additional surgery, the date of the last resection will be considered the date of definitive surgery. * 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 * NEUROCOGNITIVE FUNCTION AND QUALITY OF LIFE ASSESSMENT: * English-, Spanish-, or French- speaking * Note: Patients who speak a language other than English, Spanish, or French will be allowed to participate in ACNS2021 but will not complete the neurocognitive and quality of life assessments * No known history of neurodevelopmental disorder prior to diagnosis of NGGCT (e.g., Down syndrome, fragile X, William syndrome, intellectual disability). Patients with NF1 will be allowed to participate * Additional eligibility criteria for the COG Standardized Neuropsychological Battery only: must be at a site that has a psychologist to administer the battery * Note: If not eligible for the COG Standardized Battery, patients should still complete the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2), Pediatric Quality of Life Inventory (PedsQL), Adaptive Behavior Assessment System Third Edition (ABAS-3), and Behavior Assessment System for Children, Third Edition (BASC-3) questionnaires Exclusion Criteria: * Patients with tumors located outside the ventricles (i.e., basal ganglia, thalamus) * Patients with only mature teratoma and non-elevated markers upon tumor sampling at diagnosis * Patients who have received any prior tumor-directed therapy for their diagnosis of NGGCT other than surgical intervention and corticosteroids * Patients with metastatic disease (i.e., MRI evaluation, lumbar CSF cytology or intraoperative evidence of dissemination) * Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs * Note: Serum and urine pregnancy tests may be falsely positive due to HCGbeta-secreting germ cell tumors. Ensure the patient is not pregnant by institutional standards * 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 (149)

Children's Hospital of Alabama

Birmingham, Alabama, 35233

Suspended

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

Michael R. Mangum · Principal Investigator

Banner University Medical Center - Tucson

Tucson, Arizona, 85719

Recruiting

Site Public Contact · Contact

UACC-IIT@uacc.arizona.edu

Monica M. Davini · Principal Investigator

University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719

Suspended

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

Hung N. Tran · 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

Tom B. Davidson · Principal Investigator

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027

Suspended

Cedars-Sinai Medical Center

Los Angeles, California, 90048

Recruiting

Site Public Contact · Contact

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

Fataneh (Fae) Majlessipour · Principal Investigator

Valley Children's Hospital

Madera, California, 93636

Recruiting

Site Public Contact · Contact

559-353-3000 Research@valleychildrens.org

Ruetima Titapiwatanakun · 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

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

Alyssa T. Reddy · Principal Investigator

Children's Hospital Colorado

Aurora, Colorado, 80045

Recruiting

Site Public Contact · Contact

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

Holly B. Lindsay · 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

Asher M. Marks · Principal Investigator

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803

Recruiting

Site Public Contact · Contact

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

Sridhi Patel · 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

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

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207

Recruiting

Site Public Contact · Contact

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

Sridhi Patel · Principal Investigator

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136

Recruiting

Site Public Contact · Contact

305-243-2647

Bradley Gampel · Principal Investigator

Nicklaus Children's Hospital

Miami, Florida, 33155

Recruiting

Site Public Contact · Contact

888-624-2778

Ziad A. Khatib · 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

Sridhi Patel · 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

Stacie L. Stapleton · 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

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, 30329

Recruiting

Site Public Contact · Contact

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

Jason R. Fangusaro · 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

Alicia Lenzen · Principal Investigator

University of Illinois

Chicago, Illinois, 60612

Recruiting

Site Public Contact · Contact

312-355-3046

Dipti S. Dighe · Principal Investigator

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637

Recruiting

Site Public Contact · Contact

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

Wendy S. Darlington · Principal Investigator

Loyola University Medical Center

Maywood, Illinois, 60153

Recruiting

Site Public Contact · Contact

708-226-4357

Eugene Suh · Principal Investigator

Saint Jude Midwest Affiliate

Peoria, Illinois, 61637

Recruiting

Site Public Contact · Contact

888-226-4343

Prerna Kumar · Principal Investigator

Riley Hospital for Children

Indianapolis, Indiana, 46202

Recruiting

Sandeep Batra · Contact

317-944-8784 batras@iu.edu

Sandeep Batra · 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

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121

Recruiting

Site Public Contact · Contact

504-842-8084 Elisemarie.curry@ochsner.org

Craig Lotterman · Principal Investigator

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

Stanley Chaleff · 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

Kenneth J. Cohen · Principal Investigator

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

Recruiting

Site Public Contact · Contact

877-726-5130

Laura Wiltsie · Principal Investigator

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting

Site Public Contact · Contact

877-442-3324

Kee Kiat Yeo · Principal Investigator

C S Mott Children's Hospital

Ann Arbor, Michigan, 48109

Recruiting

Site Public Contact · Contact

800-865-1125

Andrea T. Franson · Principal Investigator

Children's Hospital of Michigan

Detroit, Michigan, 48201

Recruiting

Site Public Contact · Contact

helpdesk@childrensoncologygroup.org

Stephanie A. Toll · Principal Investigator

Michigan State University

East Lansing, Michigan, 48823

Active Not Recruiting

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503

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

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

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Recruiting

Site Public Contact · Contact

855-776-0015

Joseph Z. Wilson · 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

Mohamed S. Abdelbaki · 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

Oncology Las Vegas - Henderson

Henderson, Nevada, 89074

Suspended

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, 89135

Suspended

Renown Regional Medical Center

Reno, Nevada, 89502

Recruiting

Site Public Contact · Contact

702-384-0013 research@sncrf.org

Alan K. Ikeda · Principal Investigator

Cancer Care Specialists - Reno

Reno, Nevada, 89511

Suspended

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756

Recruiting

Site Public Contact · Contact

800-639-6918 cancer.research.nurse@dartmouth.edu

Angela Ricci · Principal Investigator

Hackensack University Medical Center

Hackensack, New Jersey, 07601

Recruiting

Site Public Contact · Contact

551-996-2897

Derek R. Hanson · Principal Investigator

Morristown Medical Center

Morristown, New Jersey, 07960

Recruiting

Site Public Contact · Contact

973-971-5900

Kathryn L. Laurie · Principal Investigator

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901

Recruiting

Site Public Contact · Contact

732-745-8600 kcovert@saintpetersuh.com

Nibal A. Zaghloul · Principal Investigator

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

New Brunswick, New Jersey, 08903

Recruiting

Site Public Contact · Contact

732-235-8675

Nehal S. Parikh · Principal Investigator

Newark Beth Israel Medical Center

Newark, New Jersey, 07112

Suspended

Saint Joseph's Regional Medical Center

Paterson, New Jersey, 07503

Recruiting

Site Public Contact · Contact

973-754-2207 HallL@sjhmc.org

Alissa Kahn · Principal Investigator

Albany Medical Center

Albany, New York, 12208

Recruiting

Site Public Contact · Contact

518-262-5513

Lauren R. Weintraub · Principal Investigator

Maimonides Medical Center

Brooklyn, New York, 11219

Recruiting

Site Public Contact · Contact

718-765-2500

Mahmut Y. Celiker · Principal Investigator

Roswell Park Cancer Institute

Buffalo, New York, 14263

Recruiting

Site Public Contact · Contact

800-767-9355 askroswell@roswellpark.org

Clare J. Twist · Principal Investigator

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

New Hyde Park, New York, 11040

Recruiting

Site Public Contact · Contact

718-470-3460

Mark P. Atlas · Principal Investigator

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016

Recruiting

Site Public Contact · Contact

CancerTrials@nyulangone.org

Elizabeth A. Raetz · Principal Investigator

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting

Site Public Contact · Contact

212-639-7592

Sameer Farouk Sait · Principal Investigator

University of Rochester

Rochester, New York, 14642

Recruiting

Site Public Contact · Contact

585-275-5830

David N. Korones · Principal Investigator

Stony Brook University Medical Center

Stony Brook, New York, 11794

Recruiting

Site Public Contact · Contact

800-862-2215

Laura E. Hogan · Principal Investigator

State University of New York Upstate Medical University

Syracuse, New York, 13210

Recruiting

Site Public Contact · Contact

315-464-5476

Melanie A. Comito · Principal Investigator

Montefiore Medical Center-Einstein Campus

The Bronx, New York, 10461

Suspended

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467

Recruiting

Site Public Contact · Contact

718-379-6866 eskwak@montefiore.org

Alice Lee · Principal Investigator

New York Medical College

Valhalla, New York, 10595

Recruiting

Site Public Contact · Contact

914-594-3794

Jessica C. Hochberg · Principal Investigator

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203

Recruiting

Site Public Contact · Contact

800-804-9376

Joel A. Kaplan · Principal Investigator

Duke University Medical Center

Durham, North Carolina, 27710

Recruiting

Site Public Contact · Contact

888-275-3853

Jessica M. Sun · Principal Investigator

East Carolina University

Greenville, North Carolina, 27834

Recruiting

Site Public Contact · Contact

252-744-1015 eubankss@ecu.edu

Andrea R. Whitfield · Principal Investigator

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

Recruiting

Site Public Contact · Contact

336-713-6771

Sarah Supples · Principal Investigator

Sanford Broadway Medical Center

Fargo, North Dakota, 58122

Recruiting

Site Public Contact · Contact

701-323-5760 OncologyClinicalTrialsFargo@sanfordhealth.org

Samuel J. Milanovich · Principal Investigator

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308

Recruiting

Site Public Contact · Contact

330-543-3193

Erin Wright · Principal Investigator

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

Recruiting

Site Public Contact · Contact

513-636-2799 cancer@cchmc.org

Trent R. Hummel · Principal Investigator

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106

Recruiting

Site Public Contact · Contact

216-844-5437

Duncan S. Stearns · Principal Investigator

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

Active Not Recruiting

Nationwide Children's Hospital

Columbus, Ohio, 43205

Recruiting

Site Public Contact · Contact

614-722-6039 Melinda.Triplet@nationwidechildrens.org

Mark A. Ranalli · Principal Investigator

Dayton Children's Hospital

Dayton, Ohio, 45404

Recruiting

Site Public Contact · Contact

800-228-4055

Jordan M. Wright · Principal Investigator

ProMedica Flower Hospital

Sylvania, Ohio, 43560

Suspended

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, 43606

Recruiting

Site Public Contact · Contact

419-824-1842 PCIOncResearch@promedica.org

Jamie L. Dargart · Principal Investigator

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

Recruiting

Site Public Contact · Contact

405-271-8777 ou-clinical-trials@ouhsc.edu

Rene Y. McNall-Knapp · Principal Investigator

Legacy Emanuel Children's Hospital

Portland, Oregon, 97227

Recruiting

Site Public Contact · Contact

503-413-2560

Jason M. Glover · Principal Investigator

Oregon Health and Science University

Portland, Oregon, 97239

Recruiting

Site Public Contact · Contact

503-494-1080 trials@ohsu.edu

Linda C. Stork · Principal Investigator

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103

Recruiting

Site Public Contact · Contact

610-402-9543 Morgan_M.Horton@lvhn.org

Jacob A. Troutman · Principal Investigator

Geisinger Medical Center

Danville, Pennsylvania, 17822

Recruiting

Site Public Contact · Contact

570-271-5251 HemonCCTrials@geisinger.edu

Jagadeesh Ramdas · Principal Investigator

Penn State Children's Hospital

Hershey, Pennsylvania, 17033

Recruiting

Site Public Contact · Contact

717-531-6012

Lisa M. McGregor · Principal Investigator

Saint Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134

Recruiting

Site Public Contact · Contact

215-427-8991

Gregory E. Halligan · Principal Investigator

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224

Recruiting

Site Public Contact · Contact

412-692-8570 jean.tersak@chp.edu

James T. Felker · Principal Investigator

Rhode Island Hospital

Providence, Rhode Island, 02903

Recruiting

Site Public Contact · Contact

401-444-1488

Bradley DeNardo · Principal Investigator

Medical University of South Carolina

Charleston, South Carolina, 29425

Recruiting

Site Public Contact · Contact

843-792-9321 hcc-clinical-trials@musc.edu

Jacqueline M. Kraveka · Principal Investigator

Prisma Health Richland Hospital

Columbia, South Carolina, 29203

Recruiting

Site Public Contact · Contact

864-522-4317 Kim.Williams3@prismahealth.org

Stuart L. Cramer · Principal Investigator

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, 29605

Recruiting

Site Public Contact · Contact

864-522-4317 Kim.Williams3@prismahealth.org

Aniket Saha · Principal Investigator

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605

Suspended

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

Recruiting

Site Public Contact · Contact

605-312-3320 OncologyClinicalTrialsSF@SanfordHealth.org

Kayelyn J. Wagner · Principal Investigator

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105

Recruiting

Site Public Contact · Contact

888-226-4343 referralinfo@stjude.org

Aditi Bagchi · Principal Investigator

The Children's Hospital at TriStar Centennial

Nashville, Tennessee, 37203

Recruiting

Site Public Contact · Contact

615-342-1919

Clinton M. Carroll · Principal Investigator

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232

Recruiting

Site Public Contact · Contact

800-811-8480

Adam J. Esbenshade · Principal Investigator

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723

Recruiting

Site Public Contact · Contact

512-628-1902 TXAUS-DL-SFCHemonc.research@ascension.org

Shannon M. Cohn · Principal Investigator

Driscoll Children's Hospital

Corpus Christi, Texas, 78411

Recruiting

Site Public Contact · Contact

361-694-5311 Crystal.DeLosSantos@dchstx.org

Nkechi I. Mba · Principal Investigator

Medical City Dallas Hospital

Dallas, Texas, 75230

Recruiting

Site Public Contact · Contact

972-566-5588

Maurizio L. Ghisoli · Principal Investigator

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390

Recruiting

Daniel C. Bowers · Contact

214-648-3896 Daniel.Bowers@utsouthwestern.edu

Daniel C. Bowers · Principal Investigator

El Paso Children's Hospital

El Paso, Texas, 79905

Recruiting

Site Public Contact · Contact

915-298-5444 ranjan.bista@ttuhsc.edu

Benjamin Carcamo · Principal Investigator

Cook Children's Medical Center

Fort Worth, Texas, 76104

Recruiting

Site Public Contact · Contact

682-885-2103 CookChildrensResearch@cookchildrens.org

Sibo Zhao · Principal Investigator

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030

Recruiting

Site Public Contact · Contact

713-798-1354 burton@bcm.edu

Jack M. Su · Principal Investigator

M D Anderson Cancer Center

Houston, Texas, 77030

Recruiting

Najat C. Daw · Contact

713-792-6315 ndaw@mdanderson.org

Najat C. Daw · Principal Investigator

Children's Hospital of San Antonio

San Antonio, Texas, 78207

Recruiting

Site Public Contact · Contact

210-704-2894 bridget.medina@christushealth.org

Julie Voeller · Principal Investigator

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229

Recruiting

Site Public Contact · Contact

210-575-6240 Vinod.GidvaniDiaz@hcahealthcare.com

Jose M. Esquilin · Principal Investigator

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

Recruiting

Site Public Contact · Contact

210-450-3800 phoresearchoffice@uthscsa.edu

Shafqat Shah · Principal Investigator

Scott and White Memorial Hospital

Temple, Texas, 76508

Recruiting

Site Public Contact · Contact

254-724-5407

Nicholas W. McGregor · Principal Investigator

Primary Children's Hospital

Salt Lake City, Utah, 84113

Recruiting

Site Public Contact · Contact

801-585-5270

Priya Chan · Principal Investigator

University of Vermont and State Agricultural College

Burlington, Vermont, 05405

Recruiting

Site Public Contact · Contact

802-656-8990 rpo@uvm.edu

Jessica L. Heath · Principal Investigator

University of Virginia Cancer Center

Charlottesville, Virginia, 22908

Recruiting

Site Public Contact · Contact

434-243-6303 uvacancertrials@hscmail.mcc.virginia.edu

Brian C. Belyea · Principal Investigator

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507

Recruiting

Site Public Contact · Contact

757-668-7243 CCBDCresearch@chkd.org

Melissa S. Mark · Principal Investigator

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298

Recruiting

Site Public Contact · Contact

804-628-6430 CTOclinops@vcu.edu

Christopher Park · Principal Investigator

Carilion Children's

Roanoke, Virginia, 24014

Recruiting

Site Public Contact · Contact

540-266-6238 wpmccarty@carilionclinic.org

Erwood G. Edwards · Principal Investigator

Seattle Children's Hospital

Seattle, Washington, 98105

Recruiting

Site Public Contact · Contact

866-987-2000

Sarah E. Leary · Principal Investigator

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204

Recruiting

Site Public Contact · Contact

800-228-6618 HopeBeginsHere@providence.org

Judy L. Felgenhauer · Principal Investigator

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, 98405

Recruiting

Site Public Contact · Contact

253-403-1461 research@multicare.org

Robert G. Irwin · Principal Investigator

Madigan Army Medical Center

Tacoma, Washington, 98431

Recruiting

Site Public Contact · Contact

253-968-6144 melissa.a.forouhar.mil@health.mil

Melissa A. Forouhar · Principal Investigator

West Virginia University Healthcare

Morgantown, West Virginia, 26506

Recruiting

Site Public Contact · Contact

304-293-7374 cancertrialsinfo@hsc.wvu.edu

Ashley E. Meyer · Principal Investigator

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792

Recruiting

Site Public Contact · Contact

800-622-8922 clinicaltrials@cancer.wisc.edu

Nicholas J. Pytel · Principal Investigator

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449

Suspended