A Study of Lower Radiotherapy Dose to Treat Children With CNS Germinoma

NCT06368817 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: ACNS2321NCI-2024-03518U10CA180886
• Study Type: interventional
• Target: 240
• Locations: 3 countries
• Sites: 109

Brief Summary

This phase II trial studies how well lower dose radiotherapy after chemotherapy (Carboplatin \& Etoposide) works in treating children with central nervous system (CNS) germinomas. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Researchers want to see if lowering the dose of standard radiotherapy (RT) after chemotherapy can help get rid of CNS germinomas with fewer long-term side effects.

Conditions

Basal Ganglia Germinoma; Diabetes Insipidus; Pineal Region Germinoma; Suprasellar Germinoma; Thalamic Germinoma; Germinoma

Outcome Measures

Primary Outcomes (1)

• Event-free survival (EFS) (Stratum I)

  Will be estimated for eligible and evaluable patients assigned to Stratum 1 using Kaplan-Meier (KM) EFS estimates at 2 and 3 years with respective 80% two-sided confidence intervals. Time from initiation of radiation to the first occurrence of any of the following events: biochemical or radiographic disease progression, disease recurrence, second malignant neoplasm, or death from any cause.

  Evaluated at 2- and 3-years post-radiation initiation

Secondary Outcomes (7)

• EFS (Stratum II)

  Evaluated at 2- and 3-years post-radiation initiation

• EFS (Stratum III)

  Evaluated at 2- and 3-years post-radiation initiation

• Radiographic response rate

  Following the completion of Induction therapy, approximately 12 weeks post-chemotherapy initiation

• Marker tumor response rate

  Following the completion of Induction therapy, approximately 12 weeks post-chemotherapy initiation

• Overall survival (OS)

  Time from initiation of radiation therapy until death by any cause, up to 10 years post-enrollment

Other Outcomes (7)

• EFS (Stratum IV and Stratum V)

  Evaluated at 2- and 3-years post-radiation initiation

• EFS (Stratum VI and Stratum VII)

  Evaluated at 2- and 3-years post-radiation initiation

• Incidence of cerebral vascular events (stroke or transient ischemic attacks)

  Up to 10 years post-enrollment

Study Arms (7)

Stratum I (carboplatin, etoposide, 3D-CRT, IMRT, surgery)

EXPERIMENTAL

See Detailed Description.

Radiation: 3-Dimensional Conformal Proton Radiation Therapy; Radiation: 3-Dimensional Conformal Radiation Therapy; Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Etoposide; Procedure: Intensity-Modulated Proton Therapy; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Lumbar Puncture; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration; Procedure: Surgical Procedure

Stratum II (carboplatin, etoposide, 3D-CRT, IMRT)

EXPERIMENTAL

Patients receive carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with localized germinoma achieving PR with normalization of markers who do not undergo second-look surgery undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 20 days. Patients undergo MRI and optional blood and tissue sample collection throughout the study. Patients may undergo LP for CSF sample collection during screening and follow up.

Radiation: 3-Dimensional Conformal Proton Radiation Therapy; Radiation: 3-Dimensional Conformal Radiation Therapy; Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Etoposide; Procedure: Intensity-Modulated Proton Therapy; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Lumbar Puncture; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration

Stratum III (carboplatin, etoposide, 3D-CRT, IMRT)

EXPERIMENTAL

Patients receive carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with localized germinoma with normalization of markers who fail to achieve CR or PR who do not undergo second-look surgery undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 24 days. Patients undergo MRI and optional blood and tissue sample collection throughout the study. Patients may undergo LP for CSF sample collection during screening and follow up.

Radiation: 3-Dimensional Conformal Proton Radiation Therapy; Radiation: 3-Dimensional Conformal Radiation Therapy; Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Etoposide; Procedure: Intensity-Modulated Proton Therapy; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Lumbar Puncture; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration

Stratum IV (carboplatin, etoposide, 3D-CRT, IMRT, surgery)

EXPERIMENTAL

Patients receive carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with metastatic germinoma achieving CR undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 20 days. Patients with metastatic germinoma and normalization of markers who fail to achieve CR may undergo second-look surgery. Patients found to have mature teratoma or non-viable tumor undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 20 days. Patients undergo MRI and optional blood and tissue sample collection throughout the study. Patients may undergo LP for CSF sample collection during screening and follow up.

Radiation: 3-Dimensional Conformal Proton Radiation Therapy; Radiation: 3-Dimensional Conformal Radiation Therapy; Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Etoposide; Procedure: Intensity-Modulated Proton Therapy; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Lumbar Puncture; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration; Procedure: Surgical Procedure

Stratum V (carboplatin, etoposide, 3D-CRT, IMRT)

EXPERIMENTAL

Patients receive carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with metastatic germinoma with normalization of markers who fail to achieve CR who do not undergo second-look surgery undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 24 days. Patients undergo MRI and optional blood and tissue sample collection throughout the study. Patients may undergo LP for CSF sample collection during screening and follow up.

Radiation: 3-Dimensional Conformal Proton Radiation Therapy; Radiation: 3-Dimensional Conformal Radiation Therapy; Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Etoposide; Procedure: Intensity-Modulated Proton Therapy; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Lumbar Puncture; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration

Stratum VI (carboplatin, etoposide, 3D-CRT, IMRT, surgery)

EXPERIMENTAL

Patients receive carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with basal ganglia and thalamic germinoma achieving CR undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 20 days. Patients with basal ganglia and thalamic germinoma and normalization of markers who fail to achieve CR may undergo second-look surgery. Patients found to have mature teratoma or non-viable tumor undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 20 days. Patients undergo MRI and optional blood and tissue sample collection throughout the study. Patients may undergo LP for CSF sample collection during screening and follow up.

Radiation: 3-Dimensional Conformal Proton Radiation Therapy; Radiation: 3-Dimensional Conformal Radiation Therapy; Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Etoposide; Procedure: Intensity-Modulated Proton Therapy; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Lumbar Puncture; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration; Procedure: Surgical Procedure

Stratum VII (carboplatin, etoposide, 3D-CRT, IMRT)

EXPERIMENTAL

Patients receive carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with basal ganglia and thalamic germinoma with normalization of markers who fail to achieve CR who do not undergo second-look surgery undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 24 days. Patients undergo MRI and optional blood and tissue sample collection throughout the study. Patients may undergo LP for CSF sample collection during screening and follow up.

Radiation: 3-Dimensional Conformal Proton Radiation Therapy; Radiation: 3-Dimensional Conformal Radiation Therapy; Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Etoposide; Procedure: Intensity-Modulated Proton Therapy; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Lumbar Puncture; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo blood and CSF sample collection

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

Stratum I (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum II (carboplatin, etoposide, 3D-CRT, IMRT); Stratum III (carboplatin, etoposide, 3D-CRT, IMRT); Stratum IV (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum V (carboplatin, etoposide, 3D-CRT, IMRT); Stratum VI (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum VII (carboplatin, etoposide, 3D-CRT, IMRT)

Carboplatin DRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Stratum I (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum II (carboplatin, etoposide, 3D-CRT, IMRT); Stratum III (carboplatin, etoposide, 3D-CRT, IMRT); Stratum IV (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum V (carboplatin, etoposide, 3D-CRT, IMRT); Stratum VI (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum VII (carboplatin, etoposide, 3D-CRT, IMRT)

Etoposide DRUG

Given IV

Also known as: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16, VP 16-213, VP 16213, VP-16, VP-16-213, VP-16213, VP16, VP16213

Stratum I (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum II (carboplatin, etoposide, 3D-CRT, IMRT); Stratum III (carboplatin, etoposide, 3D-CRT, IMRT); Stratum IV (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum V (carboplatin, etoposide, 3D-CRT, IMRT); Stratum VI (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum VII (carboplatin, etoposide, 3D-CRT, IMRT)

Intensity-Modulated Radiation Therapy RADIATION

Undergo IMRT

Also known as: IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy

Stratum I (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum II (carboplatin, etoposide, 3D-CRT, IMRT); Stratum III (carboplatin, etoposide, 3D-CRT, IMRT); Stratum IV (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum V (carboplatin, etoposide, 3D-CRT, IMRT); Stratum VI (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum VII (carboplatin, etoposide, 3D-CRT, IMRT)

Lumbar Puncture PROCEDURE

Undergo LP

Also known as: LP, Spinal Tap

Stratum I (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum II (carboplatin, etoposide, 3D-CRT, IMRT); Stratum III (carboplatin, etoposide, 3D-CRT, IMRT); Stratum IV (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum V (carboplatin, etoposide, 3D-CRT, IMRT); Stratum VI (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum VII (carboplatin, etoposide, 3D-CRT, IMRT)

Magnetic Resonance Imaging PROCEDURE

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

Stratum I (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum II (carboplatin, etoposide, 3D-CRT, IMRT); Stratum III (carboplatin, etoposide, 3D-CRT, IMRT); Stratum IV (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum V (carboplatin, etoposide, 3D-CRT, IMRT); Stratum VI (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum VII (carboplatin, etoposide, 3D-CRT, IMRT)

Questionnaire Administration OTHER

Ancillary studies

Stratum I (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum II (carboplatin, etoposide, 3D-CRT, IMRT); Stratum III (carboplatin, etoposide, 3D-CRT, IMRT); Stratum IV (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum V (carboplatin, etoposide, 3D-CRT, IMRT); Stratum VI (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum VII (carboplatin, etoposide, 3D-CRT, IMRT)

Surgical Procedure PROCEDURE

Undergo second-look surgery

Also known as: Operation, Surgery, Surgery Type, Surgery, NOS, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery

Stratum I (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum IV (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum VI (carboplatin, etoposide, 3D-CRT, IMRT, surgery)

3-Dimensional Conformal Radiation Therapy RADIATION

Undergo 3D-CRT

Also known as: 3-dimensional radiation therapy, 3D Conformal, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D radiotherapy, 3D-CRT, Conformal Therapy, Radiation Conformal Therapy, Radiation, 3D Conformal, Three dimensional external beam radiation therapy (procedure)

Stratum I (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum II (carboplatin, etoposide, 3D-CRT, IMRT); Stratum III (carboplatin, etoposide, 3D-CRT, IMRT); Stratum IV (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum V (carboplatin, etoposide, 3D-CRT, IMRT); Stratum VI (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum VII (carboplatin, etoposide, 3D-CRT, IMRT)

3-Dimensional Conformal Proton Radiation Therapy RADIATION

Undergo 3D-CPRT

Also known as: 3D-CPRT

Stratum I (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum II (carboplatin, etoposide, 3D-CRT, IMRT); Stratum III (carboplatin, etoposide, 3D-CRT, IMRT); Stratum IV (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum V (carboplatin, etoposide, 3D-CRT, IMRT); Stratum VI (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum VII (carboplatin, etoposide, 3D-CRT, IMRT)

Intensity-Modulated Proton Therapy PROCEDURE

Undergo IMPT

Also known as: IMPT

Stratum I (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum II (carboplatin, etoposide, 3D-CRT, IMRT); Stratum III (carboplatin, etoposide, 3D-CRT, IMRT); Stratum IV (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum V (carboplatin, etoposide, 3D-CRT, IMRT); Stratum VI (carboplatin, etoposide, 3D-CRT, IMRT, surgery); Stratum VII (carboplatin, etoposide, 3D-CRT, IMRT)

Eligibility Criteria

• Age: 3 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients must be ≥ 3 years and \< 30 years at the time of study enrollment
• Patients must be newly-diagnosed primary localized germinoma of the suprasellar and/or pineal region by pathology and/or serum and/or CSF hCGbeta 5-50 mIU/mL AND institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists), including tumors with contiguous ventricular or unifocal parenchymal extension. No histologic confirmation required
• Patients with EITHER (A) bifocal (pineal + suprasellar) involvement OR (B) pineal lesion with diabetes insipidus (DI) AND hCGbeta ≤ 100 mIU/mL in serum and/or CSF AND institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists) in both serum and CSF. No histologic confirmation required
• Patients with hCGbeta 51-100 mIU/mL in serum and/or CSF and institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists) in both serum and CSF. Histologic confirmation of germinoma IS required
• Patients with germinoma of the basal ganglia and or/thalamic primary sites are eligible
• Patients with metastatic germinoma including non-contiguous disease or distant disease in the brain, ventricles, or spine are eligible
• Patients with germinoma admixed with mature teratoma are eligible
• 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 eligibility confirmed by Rapid Central Imaging Review performed on APEC14B1-CNS
• Imaging studies must be obtained within 31 days prior to study enrollment and start of protocol therapy. (Note: for patients that have had surgery and post-operative imaging performed, it is the post-operative MRI that must be obtained within 31 days prior to enrollment.)
• Patients must have a cranial magnetic resonance imaging (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
• Patients must have a spine MRI with gadolinium obtained at diagnosis/prior to enrollment
• Patients must be enrolled, and protocol therapy must begin, no later than 31 days after definitive surgery or clinical diagnosis, whichever is later
• Patients must have eligibility confirmed by Rapid Central Tumor Marker Review performed on APEC14B1-CNS
• 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. Of note, lumbar CSF should not be performed prior to obtaining spine MRI, as this can make interpretation of the spine MRI less clear

You may not qualify if:

• Patients with any of the following malignant pathological elements are not eligible:
• Endodermal sinus (yolk sac)
• Embryonal carcinoma, choriocarcinoma
• Malignant/immature teratoma and mixed germ cell tumor (GCT) (i.e., may include some germinoma)
• Patients with only mature teratoma upon tumor sampling at diagnosis and negative tumor markers are not eligible
• Patients who have received any prior tumor-directed therapy for their diagnosis of germinoma other than surgical intervention and corticosteroids are not eligible
• 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.
• 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
• 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

Sponsors & Collaborators

• Children's Oncology Group: lead

Study Sites (109)

USA Health Strada Patient Care Center

Mobile, Alabama, 36604, United States

RECRUITING

Phoenix Childrens Hospital

Phoenix, Arizona, 85016, United States

RECRUITING

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591, United States

RECRUITING

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

RECRUITING

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

RECRUITING

Children's Hospital of Orange County

Orange, California, 92868, United States

RECRUITING

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, 94304, United States

RECRUITING

Rady Children's Hospital - San Diego

San Diego, California, 92123, United States

RECRUITING

UCSF Medical Center-Mission Bay

San Francisco, California, 94158, United States

RECRUITING

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, 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

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States

RECRUITING

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207, United States

RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

RECRUITING

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

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

Sacred Heart Hospital

Pensacola, Florida, 32504, United States

ACTIVE NOT RECRUITING

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

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

RECRUITING

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

RECRUITING

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States

RECRUITING

Lurie Children's Hospital-Chicago

Chicago, Illinois, 60611, United States

RECRUITING

University of Illinois

Chicago, Illinois, 60612, United States

RECRUITING

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

RECRUITING

Loyola University Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

RECRUITING

Norton Children's Hospital

Louisville, Kentucky, 40202, United States

RECRUITING

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

C S Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

RECRUITING

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

Grand Rapids, Michigan, 49503, United States

RECRUITING

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404, United States

RECRUITING

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

RECRUITING

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

RECRUITING

Cardinal Glennon Children's Medical Center

St Louis, Missouri, 63104, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, 68114, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, 89135, United States

RECRUITING

Summerlin Hospital Medical Center

Las Vegas, Nevada, 89144, United States

RECRUITING

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

RECRUITING

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

New Brunswick, New Jersey, 08903, United States

RECRUITING

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

RECRUITING

Saint Joseph's Regional Medical Center

Paterson, New Jersey, 07503, United States

RECRUITING

Albany Medical Center

Albany, New York, 12208, United States

RECRUITING

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

New Hyde Park, New York, 11040, United States

RECRUITING

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

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

New York, New York, 10032, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

RECRUITING

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

RECRUITING

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Sanford Broadway Medical Center

Fargo, North Dakota, 58122, United States

RECRUITING

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Saint Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134, United States

RECRUITING

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Prisma Health Richland Hospital

Columbia, South Carolina, 29203, United States

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

RECRUITING

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

RECRUITING

Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States

RECRUITING

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

RECRUITING

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

RECRUITING

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030, United States

RECRUITING

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Children's Hospital of San Antonio

San Antonio, Texas, 78207, United States

RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

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

RECRUITING

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204, United States

RECRUITING

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States

RECRUITING

John Hunter Children's Hospital

Hunter Regional Mail Centre, New South Wales, 2310, Australia

RECRUITING

Sydney Children's Hospital

Randwick, New South Wales, 2031, Australia

RECRUITING

The Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

RECRUITING

Queensland Children's Hospital

South Brisbane, Queensland, 4101, Australia

RECRUITING

Royal Children's Hospital

Parkville, Victoria, 3052, Australia

RECRUITING

Perth Children's Hospital

Perth, Western Australia, 6009, Australia

RECRUITING

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

RECRUITING

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

RECRUITING

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

RECRUITING

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

RECRUITING

Children's Hospital

London, Ontario, N6A 5W9, Canada

RECRUITING

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

The Montreal Children's Hospital of the MUHC

Montreal, Quebec, H3H 1P3, Canada

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

MeSH Terms

Conditions

Diabetes Insipidus; Germinoma

Interventions

Radiotherapy, Conformal; Specimen Handling; Carboplatin; Etoposide; Radiotherapy, Intensity-Modulated; Spinal Puncture; Magnetic Resonance Spectroscopy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Biopsy; Diagnostic Techniques, Neurological; Punctures; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Mohamed S Abdelbaki

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 16, 2024
• Study Start: October 22, 2024
• Primary Completion (Estimated): November 4, 2033
• Study Completion (Estimated): November 4, 2033
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

AU (6); US (92); CA (11)