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Phase 2Recruiting

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

Sponsored by Children's Oncology Group

About this study

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.

PRIMARY OBJECTIVE: I. To determine whether 12 Gy whole ventricular irradiation (WVI) and 12 Gy tumor boost would maintain similar efficacy compared to ACNS1123 stratum 2 as measured by event-free survival (EFS) in eligible patients with localized primary central nervous system (CNS) germinoma who present with serum and/or cerebrospinal fluid (CSF) human chorionic gonadotropin-beta (hCGbeta) ≤ 100 IU/L and normal alpha-fetoprotein (AFP), and meet complete response (CR) or continued complete response (CCR) criteria following chemotherapy/second-look surgery (Stratum 1). SECONDARY OBJECTIVES: I. To estimate the EFS distribution for patients with localized midline - including bifocal - CNS germinoma with partial response (PR) after chemotherapy, followed by 18 Gy WVI and 12 Gy tumor boost (…

Where this study is enrolling (95)

  • USA Health Strada Patient Care Center

    Mobile, Alabama

    Call 800-388-8721

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  • Phoenix Childrens Hospital

    Phoenix, Arizona

    Call 602-933-1000

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  • Arkansas Children's Hospital

    Little Rock, Arkansas

    Call 501-364-7373

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  • Children's Hospital Los Angeles

    Los Angeles, California

    Call 323-361-4110

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  • UCSF Benioff Children's Hospital Oakland

    Oakland, California

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Show all 95 locations

  • Children's Hospital of Orange County

    Orange, California

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  • Lucile Packard Children's Hospital Stanford University

    Palo Alto, California

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  • UCSF Medical Center-Mission Bay

    San Francisco, California

    I'm interested

  • Rady Children's Hospital - San Diego

    San Diego, California

    Call 858-966-5934

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  • Loma Linda University Medical Center

    Loma Linda, California

    Call 909-558-4050

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  • Children's Hospital Colorado

    Aurora, Colorado

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  • Yale University

    New Haven, Connecticut

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  • Connecticut Children's Medical Center

    Hartford, Connecticut

    Call 860-545-9981

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  • Alfred I duPont Hospital for Children

    Wilmington, Delaware

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  • Children's National Medical Center

    Washington D.C., District of Columbia

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  • Nemours Children's Clinic - Pensacola

    Pensacola, Florida

    I'm interested

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    Hollywood, Florida

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  • Arnold Palmer Hospital for Children

    Orlando, Florida

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

    Tampa, Florida

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  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida

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  • Nemours Children's Hospital

    Orlando, Florida

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  • Nicklaus Children's Hospital

    Miami, Florida

    Call 888-624-2778

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  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida

    Call 305-243-2647

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  • Nemours Children's Clinic-Jacksonville

    Jacksonville, Florida

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  • Children's Healthcare of Atlanta - Arthur M Blank Hospital

    Atlanta, Georgia

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  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii

    Call 808-983-6090

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  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho

    I'm interested

  • Lurie Children's Hospital-Chicago

    Chicago, Illinois

    I'm interested

  • Loyola University Medical Center

    Maywood, Illinois

    Call 708-226-4357

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  • University of Illinois

    Chicago, Illinois

    Call 312-355-3046

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  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois

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  • Riley Hospital for Children

    Indianapolis, Indiana

    Call 800-248-1199

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  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa

    Call 800-237-1225

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  • Norton Children's Hospital

    Louisville, Kentucky

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  • Maine Children's Cancer Program

    Scarborough, Maine

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  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland

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  • Dana-Farber Cancer Institute

    Boston, Massachusetts

    Call 877-442-3324

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

    Grand Rapids, Michigan

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  • C S Mott Children's Hospital

    Ann Arbor, Michigan

    Call 800-865-1125

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  • Children's Hospitals and Clinics of Minnesota - Minneapolis

    Minneapolis, Minnesota

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  • Mayo Clinic in Rochester

    Rochester, Minnesota

    Call 855-776-0015

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  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota

    Call 612-624-2620

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  • University of Mississippi Medical Center

    Jackson, Mississippi

    Call 601-815-6700

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  • Children's Mercy Hospitals and Clinics

    Kansas City, Missouri

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  • Cardinal Glennon Children's Medical Center

    St Louis, Missouri

    Call 314-268-4000

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  • Washington University School of Medicine

    St Louis, Missouri

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  • Children's Hospital and Medical Center of Omaha

    Omaha, Nebraska

    Call 402-955-3949

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  • University of Nebraska Medical Center

    Omaha, Nebraska

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  • Summerlin Hospital Medical Center

    Las Vegas, Nevada

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  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    Las Vegas, Nevada

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  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire

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  • Hackensack University Medical Center

    Hackensack, New Jersey

    Call 551-996-2897

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

    New Brunswick, New Jersey

    Call 732-235-8675

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  • Saint Peter's University Hospital

    New Brunswick, New Jersey

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  • Saint Joseph's Regional Medical Center

    Paterson, New Jersey

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  • Newark Beth Israel Medical Center

    Newark, New Jersey

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  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York

    I'm interested

  • Albany Medical Center

    Albany, New York

    Call 518-262-5513

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

    New Hyde Park, New York

    Call 718-470-3460

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

    New York, New York

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  • Memorial Sloan Kettering Cancer Center

    New York, New York

    Call 212-639-7592

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  • Mount Sinai Hospital

    New York, New York

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  • Montefiore Medical Center - Moses Campus

    The Bronx, New York

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  • State University of New York Upstate Medical University

    Syracuse, New York

    Call 315-464-5476

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  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina

    Call 336-713-6771

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  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina

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  • Sanford Broadway Medical Center

    Fargo, North Dakota

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  • Nationwide Children's Hospital

    Columbus, Ohio

    I'm interested

  • Rainbow Babies and Childrens Hospital

    Cleveland, Ohio

    Call 216-844-5437

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  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma

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  • Oregon Health and Science University

    Portland, Oregon

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  • Saint Christopher's Hospital for Children

    Philadelphia, Pennsylvania

    I'm interested

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania

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  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania

    I'm interested

  • Rhode Island Hospital

    Providence, Rhode Island

    Call 401-444-1488

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  • Prisma Health Richland Hospital

    Columbia, South Carolina

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  • BI-LO Charities Children's Cancer Center

    Greenville, South Carolina

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  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota

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  • Saint Jude Children's Research Hospital

    Memphis, Tennessee

    I'm interested

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee

    Call 800-811-8480

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  • East Tennessee Childrens Hospital

    Knoxville, Tennessee

    Call 865-541-8266

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  • UT MD Anderson Cancer Center

    Houston, Texas

    I'm interested

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas

    I'm interested

  • Medical City Dallas Hospital

    Dallas, Texas

    Call 972-566-5588

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  • Driscoll Children's Hospital

    Corpus Christi, Texas

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  • Dell Children's Medical Center of Central Texas

    Austin, Texas

    I'm interested

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas

    I'm interested

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas

    I'm interested

  • Children's Hospital of San Antonio

    San Antonio, Texas

    I'm interested

  • Primary Children's Hospital

    Salt Lake City, Utah

    Call 801-585-5270

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  • University of Virginia Cancer Center

    Charlottesville, Virginia

    I'm interested

  • Children's Hospital of The King's Daughters

    Norfolk, Virginia

    I'm interested

  • Seattle Children's Hospital

    Seattle, Washington

    Call 866-987-2000

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  • Providence Sacred Heart Medical Center and Children's Hospital

    Spokane, Washington

    I'm interested

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin

    I'm interested
Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.