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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Children's Oncology Group • ClinicalTrials.gov ID: NCT06368817

Registry updated: 2026-08-25
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Description

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.

Interventions

  • 3-Dimensional Conformal Proton Radiation Therapy (Radiation)
    Undergo 3D-CPRT
  • 3-Dimensional Conformal Radiation Therapy (Radiation)
    Undergo 3D-CRT
  • Biospecimen Collection (Procedure)
    Undergo blood and CSF sample collection
  • Carboplatin (Drug)
    Given IV
  • Etoposide (Drug)
    Given IV
  • Intensity-Modulated Proton Therapy (Procedure)
    Undergo IMPT
  • Intensity-Modulated Radiation Therapy (Radiation)
    Undergo IMRT
  • Lumbar Puncture (Procedure)
    Undergo LP
  • Magnetic Resonance Imaging (Procedure)
    Undergo MRI
  • Questionnaire Administration (Other)
    Ancillary studies
  • Surgical Procedure (Procedure)
    Undergo second-look surgery

Eligibility criteria

Inclusion Criteria: * 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 * Patients must have CSF tumor markers obtained prior to study 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. Ideally serum and CSF tumor markers should be collected at the same time and processed without delay * For patients with solid tumors: Peripheral absolute neutrophil count (ANC) \>= 1000/uL (Must be performed within 7 days prior to enrollment unless otherwise indicated) * For patients with solid tumors: Platelet count \>= 100,000/uL (transfusion independent) (Must be performed within 7 days prior to enrollment unless otherwise indicated) * For patients with solid tumors: Hemoglobin \>= 8.0 g/dL (may receive red blood cell \[RBC\] transfusions) (Must be performed within 7 days prior to enrollment unless otherwise indicated) * For pediatric patients (age 3-17 years): A serum creatinine based on age/sex as follows (Must be performed within 7 days prior to enrollment unless otherwise indicated): * Age: 3 to \< 6 years; maximum serum creatinine (mg/dL): 0.8 (male); 0.8 (female) * Age: 6 to \< 10 years; maximum serum creatinine (mg/dL): 1 (male); 1 (female) * Age: 10 to \< 13 years; maximum serum creatinine (mg/dL): 1.2 (male); 1.2 (female) * Age: 13 to \< 16 years; maximum serum creatinine (mg/dL): 1.5 (male); 1.4 (female) * Age: ≥ 17 years; maximum serum creatinine (mg/dL): 1.7 (male); 1.4 (female) OR a 24-hour urine creatinine clearance ≥ 70 mL/min/1.73 m\^2 OR a glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard). * Note: Estimated GFR (eGFR) from serum or plasma creatinine, cystatin C or other estimates are not acceptable for determining eligibility. * For adult patients (age 18 years or older) (Must be performed within 7 days prior to enrollment unless otherwise indicated): * Creatinine clearance ≥ 70 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age (Must be performed within 7 days prior to enrollment unless otherwise indicated) * Serum glutamic-pyruvic transaminase (SGPT) (alanine transaminase \[ALT\]) ≤ 135 U/L (Must be performed within 7 days prior to enrollment unless otherwise indicated) * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L * No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \> 94% if there is clinical indication for determination * Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled * CNS toxicity =\< grade 2 * Patients must not be in status epilepticus, coma or assisted ventilation prior to study enrollment * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load are eligible for this study Exclusion Criteria: * 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

Conditions

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

Locations

  • USA Health Strada Patient Care Center — Mobile, Alabama, United States
  • Phoenix Childrens Hospital — Phoenix, Arizona, United States
  • Arkansas Children's Hospital — Little Rock, Arkansas, United States
  • Loma Linda University Medical Center — Loma Linda, California, United States
  • Children's Hospital Los Angeles — Los Angeles, California, United States
  • UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
  • Children's Hospital of Orange County — Orange, California, United States
  • Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
  • Rady Children's Hospital - San Diego — San Diego, California, United States
  • UCSF Medical Center-Mission Bay — San Francisco, California, United States
  • Children's Hospital Colorado — Aurora, Colorado, United States
  • Connecticut Children's Medical Center — Hartford, Connecticut, United States
  • Yale University — New Haven, Connecticut, United States
  • Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
  • Children's National Medical Center — Washington D.C., District of Columbia, United States
  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital — Hollywood, Florida, United States
  • Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States
  • University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
  • Nicklaus Children's Hospital — Miami, Florida, United States
  • Arnold Palmer Hospital for Children — Orlando, Florida, United States
  • Nemours Children's Hospital — Orlando, Florida, United States
  • Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States
  • Sacred Heart Hospital — Pensacola, Florida, United States
  • Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
  • Saint Joseph's Hospital/Children's Hospital-Tampa — Tampa, Florida, United States
  • Children's Healthcare of Atlanta - Arthur M Blank Hospital — Atlanta, Georgia, United States
  • Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States
  • Saint Luke's Cancer Institute - Boise — Boise, Idaho, United States
  • Lurie Children's Hospital-Chicago — Chicago, Illinois, United States
  • University of Illinois — Chicago, Illinois, United States
  • University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
  • Loyola University Medical Center — Maywood, Illinois, United States
  • Riley Hospital for Children — Indianapolis, Indiana, United States
  • University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
  • Norton Children's Hospital — Louisville, Kentucky, United States
  • Maine Children's Cancer Program — Scarborough, Maine, United States
  • Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States
  • Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
  • Dana-Farber Cancer Institute — Boston, Massachusetts, United States
  • C S Mott Children's Hospital — Ann Arbor, Michigan, United States
  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital — Grand Rapids, Michigan, United States
  • Children's Hospitals and Clinics of Minnesota - Minneapolis — Minneapolis, Minnesota, United States
  • University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota, United States
  • Mayo Clinic in Rochester — Rochester, Minnesota, United States
  • University of Mississippi Medical Center — Jackson, Mississippi, United States
  • Children's Mercy Hospitals and Clinics — Kansas City, Missouri, United States
  • Cardinal Glennon Children's Medical Center — St Louis, Missouri, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • Children's Hospital and Medical Center of Omaha — Omaha, Nebraska, United States
  • University of Nebraska Medical Center — Omaha, Nebraska, United States
  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation — Las Vegas, Nevada, United States
  • Summerlin Hospital Medical Center — Las Vegas, Nevada, United States
  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center — Lebanon, New Hampshire, United States
  • Hackensack University Medical Center — Hackensack, New Jersey, United States
  • Saint Peter's University Hospital — New Brunswick, New Jersey, United States
  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States
  • Newark Beth Israel Medical Center — Newark, New Jersey, United States
  • Saint Joseph's Regional Medical Center — Paterson, New Jersey, United States
  • Albany Medical Center — Albany, New York, United States
  • The Steven and Alexandra Cohen Children's Medical Center of New York — New Hyde Park, New York, United States
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York, United States
  • Mount Sinai Hospital — New York, New York, United States
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • State University of New York Upstate Medical University — Syracuse, New York, United States
  • Montefiore Medical Center - Moses Campus — The Bronx, New York, United States
  • UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
  • Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
  • Sanford Broadway Medical Center — Fargo, North Dakota, United States
  • Rainbow Babies and Childrens Hospital — Cleveland, Ohio, United States
  • Nationwide Children's Hospital — Columbus, Ohio, United States
  • University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
  • Oregon Health and Science University — Portland, Oregon, United States
  • Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
  • Saint Christopher's Hospital for Children — Philadelphia, Pennsylvania, United States
  • Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
  • Rhode Island Hospital — Providence, Rhode Island, United States
  • Prisma Health Richland Hospital — Columbia, South Carolina, United States
  • BI-LO Charities Children's Cancer Center — Greenville, South Carolina, United States
  • Sanford USD Medical Center - Sioux Falls — Sioux Falls, South Dakota, United States
  • East Tennessee Childrens Hospital — Knoxville, Tennessee, United States
  • Saint Jude Children's Research Hospital — Memphis, Tennessee, United States
  • Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States
  • Dell Children's Medical Center of Central Texas — Austin, Texas, United States
  • Driscoll Children's Hospital — Corpus Christi, Texas, United States
  • Medical City Dallas Hospital — Dallas, Texas, United States
  • UT Southwestern/Simmons Cancer Center-Dallas — Dallas, Texas, United States
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center — Houston, Texas, United States
  • UT MD Anderson Cancer Center — Houston, Texas, United States
  • Children's Hospital of San Antonio — San Antonio, Texas, United States
  • University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
  • Primary Children's Hospital — Salt Lake City, Utah, United States
  • University of Virginia Cancer Center — Charlottesville, Virginia, United States
  • Children's Hospital of The King's Daughters — Norfolk, Virginia, United States
  • Seattle Children's Hospital — Seattle, Washington, United States
  • Providence Sacred Heart Medical Center and Children's Hospital — Spokane, Washington, United States
  • University of Wisconsin Carbone Cancer Center - University Hospital — Madison, Wisconsin, United States
  • John Hunter Children's Hospital — Hunter Regional Mail Centre, New South Wales, Australia
  • Sydney Children's Hospital — Randwick, New South Wales, Australia
  • The Children's Hospital at Westmead — Westmead, New South Wales, Australia
  • Queensland Children's Hospital — South Brisbane, Queensland, Australia
  • Women's and Children's Hospital-Adelaide — North Adelaide, South Australia, Australia
  • Royal Children's Hospital — Parkville, Victoria, Australia
  • Perth Children's Hospital — Perth, Western Australia, Australia
  • University of Alberta Hospital — Edmonton, Alberta, Canada
  • British Columbia Children's Hospital — Vancouver, British Columbia, Canada
  • CancerCare Manitoba — Winnipeg, Manitoba, Canada
  • IWK Health Centre — Halifax, Nova Scotia, Canada
  • McMaster Children's Hospital at Hamilton Health Sciences — Hamilton, Ontario, Canada
  • Children's Hospital — London, Ontario, Canada
  • Hospital for Sick Children — Toronto, Ontario, Canada
  • The Montreal Children's Hospital of the MUHC — Montreal, Quebec, Canada
  • Centre Hospitalier Universitaire Sainte-Justine — Montreal, Quebec, Canada
  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont — Sherbrooke, Quebec, Canada
  • CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) — Québec, Canada
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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