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A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
Study Purpose
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.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 3 Years - 29 Years |
| Gender | All |
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.
- - 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 must have a cranial MRI with and without gadolinium at diagnosis/prior to enrollment.
- - Patients must have a spine MRI with gadolinium obtained at diagnosis/prior to enrollment.
- - Lumbar CSF must be obtained prior to study enrollment unless medically contraindicated.
- - Patients must have RAPID CENTRAL TUMOR MARKER REVIEW CSF tumor markers obtained prior to enrollment unless medically contraindicated.
- - 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.
- - 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).
- - 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.
- - Lactating females who plan to breastfeed their infants.
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04684368 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Children's Oncology Group |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Shannon M MacDonald |
| Principal Investigator Affiliation | Children's Oncology Group |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other, NIH |
| Overall Status | Active, not recruiting |
| Countries | Australia, Canada, New Zealand, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Central Nervous System Nongerminomatous Germ Cell Tumor, Choriocarcinoma, Embryonal Carcinoma, Immature Teratoma, Malignant Teratoma, Mixed Germ Cell Tumor, Pineal Region Germ Cell Tumor, Pineal Region Immature Teratoma, Pineal Region Yolk Sac Tumor, Suprasellar Germ Cell Tumor |
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).
- 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.
- 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.
- III. To compare local vs.#46; 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.
- - Patients who achieve radiographic CR/PR with marker normalization proceed to WVSCI.
- - Patients who achieve less than radiographic CR/PR with marker normalization proceed to second-look surgery (unless contraindicated).
- - Patients who achieve less than radiographic CR/PR without marker normalization proceed to second-look surgery (unless contraindicated).
- - Patients who achieve radiographic PR without marker normalization proceed to second-look surgery (unless contraindicated).
Arms
Experimental: Plan A (chemotherapy, WVSCI, second-look surgery if needed)
See Outline in Detailed Description.
Experimental: Plan B (chemotherapy, HDCSCR, second-look surgery if needed)
See Outline in Detailed Description.
Interventions
Procedure: - Biospecimen Collection
Undergo collection of CSF and blood samples
Drug: - Carboplatin
Given IV
Drug: - Etoposide
Given IV
Biological: - Filgrastim
Given subcutaneously (SC) or IV
Drug: - Ifosfamide
Given IV
Procedure: - Magnetic Resonance Imaging
Undergo MRI
Drug: - Mesna
Given IV or orally
Biological: - Pegfilgrastim
Given SC
Procedure: - Peripheral Blood Stem Cell Transplantation
Undergo PBSC transplant
Other: - Questionnaire Administration
Ancillary studies
Radiation: - Radiation Therapy
Undergo WVSCI radiation therapy
Radiation: - Radiation Therapy
Undergo radiation therapy
Procedure: - Second-Look Surgery
Undergo second-look surgery if needed
Drug: - Thiotepa
Given IV
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
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Children's Hospital of Alabama
Birmingham, Alabama, 35233
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Providence Alaska Medical Center
Anchorage, Alaska, 99508
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Banner Children's at Desert
Mesa, Arizona, 85202
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Phoenix Childrens Hospital
Phoenix, Arizona, 85016
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Banner University Medical Center - Tucson
Tucson, Arizona, 85719
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University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719
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Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
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Kaiser Permanente Downey Medical Center
Downey, California, 90242
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Loma Linda University Medical Center
Loma Linda, California, 92354
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Miller Children's and Women's Hospital Long Beach
Long Beach, California, 90806
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Children's Hospital Los Angeles
Los Angeles, California, 90027
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Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
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Cedars Sinai Medical Center
Los Angeles, California, 90048
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Valley Children's Hospital
Madera, California, 93636
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Kaiser Permanente-Oakland
Oakland, California, 94611
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Children's Hospital of Orange County
Orange, California, 92868
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Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304
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Rady Children's Hospital - San Diego
San Diego, California, 92123
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UCSF Medical Center-Mission Bay
San Francisco, California, 94158
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Children's Hospital Colorado
Aurora, Colorado, 80045
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Connecticut Children's Medical Center
Hartford, Connecticut, 06106
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Yale University
New Haven, Connecticut, 06520
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Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
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Children's National Medical Center
Washington, District of Columbia, 20010
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Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
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University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610
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Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
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University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
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Address
Nicklaus Children's Hospital
Miami, Florida, 33155
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Arnold Palmer Hospital for Children
Orlando, Florida, 32806
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Nemours Children's Hospital
Orlando, Florida, 32827
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Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32504
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Sacred Heart Hospital
Pensacola, Florida, 32504
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Johns Hopkins All Children's Hospital
Saint Petersburg, Florida, 33701
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Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607
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Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, 30329
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Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
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Address
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
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Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611
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Address
University of Illinois
Chicago, Illinois, 60612
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University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
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Address
Loyola University Medical Center
Maywood, Illinois, 60153
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Address
Saint Jude Midwest Affiliate
Peoria, Illinois, 61637
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Address
Riley Hospital for Children
Indianapolis, Indiana, 46202
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Address
Blank Children's Hospital
Des Moines, Iowa, 50309
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Address
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
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University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
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Norton Children's Hospital
Louisville, Kentucky, 40202
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Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
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Address
Eastern Maine Medical Center
Bangor, Maine, 04401
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Maine Children's Cancer Program
Scarborough, Maine, 04074
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Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
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Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
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Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
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C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
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Address
Children's Hospital of Michigan
Detroit, Michigan, 48201
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Michigan State University
East Lansing, Michigan, 48823
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Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
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Address
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
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Corewell Health Children's
Royal Oak, Michigan, 48073
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Address
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
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Address
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
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Address
University of Mississippi Medical Center
Jackson, Mississippi, 39216
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Address
University of Missouri Children's Hospital
Columbia, Missouri, 65212
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Address
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
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Address
Cardinal Glennon Children's Medical Center
Saint Louis, Missouri, 63104
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Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
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Address
Mercy Hospital Saint Louis
Saint Louis, Missouri, 63141
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Address
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114
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Address
University of Nebraska Medical Center
Omaha, Nebraska, 68198
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Address
GenesisCare USA - Las Vegas
Las Vegas, Nevada, 89109
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Address
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
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Address
Renown Regional Medical Center
Reno, Nevada, 89502
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Address
Cancer Care Specialists - Reno
Reno, Nevada, 89511
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Address
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
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Address
Hackensack University Medical Center
Hackensack, New Jersey, 07601
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Morristown Medical Center
Morristown, New Jersey, 07960
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Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
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Address
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
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Newark Beth Israel Medical Center
Newark, New Jersey, 07112
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Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503
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Albany Medical Center
Albany, New York, 12208
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Montefiore Medical Center-Einstein Campus
Bronx, New York, 10461
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Montefiore Medical Center - Moses Campus
Bronx, New York, 10467
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Maimonides Medical Center
Brooklyn, New York, 11219
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The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040
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Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065
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Address
Stony Brook University Medical Center
Stony Brook, New York, 11794
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State University of New York Upstate Medical University
Syracuse, New York, 13210
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New York Medical College
Valhalla, New York, 10595
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Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
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Duke University Medical Center
Durham, North Carolina, 27710
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Address
East Carolina University
Greenville, North Carolina, 27834
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Address
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
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Address
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
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Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
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Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106
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Cleveland Clinic Foundation
Cleveland, Ohio, 44195
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Nationwide Children's Hospital
Columbus, Ohio, 43205
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Dayton Children's Hospital
Dayton, Ohio, 45404
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ProMedica Flower Hospital
Sylvania, Ohio, 43560
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ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
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Legacy Emanuel Children's Hospital
Portland, Oregon, 97227
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Oregon Health and Science University
Portland, Oregon, 97239
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Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
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Geisinger Medical Center
Danville, Pennsylvania, 17822
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Penn State Children's Hospital
Hershey, Pennsylvania, 17033
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Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
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Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
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Rhode Island Hospital
Providence, Rhode Island, 02903
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Medical University of South Carolina
Charleston, South Carolina, 29425
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Prisma Health Richland Hospital
Columbia, South Carolina, 29203
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Address
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605
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Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
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Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
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Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105
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The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203
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Address
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
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Address
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
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Address
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
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Address
Medical City Dallas Hospital
Dallas, Texas, 75230
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Address
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
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Address
El Paso Children's Hospital
El Paso, Texas, 79905
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Address
Cook Children's Medical Center
Fort Worth, Texas, 76104
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Address
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
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Address
M D Anderson Cancer Center
Houston, Texas, 77030
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Address
Children's Hospital of San Antonio
San Antonio, Texas, 78207
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Address
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229
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Address
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
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Address
Primary Children's Hospital
Salt Lake City, Utah, 84113
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Address
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
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Address
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Status
Address
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
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Address
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
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Address
Carilion Children's
Roanoke, Virginia, 24014
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Address
Seattle Children's Hospital
Seattle, Washington, 98105
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Address
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
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Address
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405
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Address
Madigan Army Medical Center
Tacoma, Washington, 98431
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Address
West Virginia University Healthcare
Morgantown, West Virginia, 26506
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Address
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
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Address
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
International Sites
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Sydney Children's Hospital
Randwick, New South Wales, 2031
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The Children's Hospital at Westmead
Westmead, New South Wales, 2145
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Address
Queensland Children's Hospital
South Brisbane, Queensland, 4101
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Address
Royal Children's Hospital
Parkville, Victoria, 3052
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Address
Perth Children's Hospital
Perth, Western Australia, 6009
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Address
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
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Address
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
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Address
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
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Address
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
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Address
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
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Address
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5
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Address
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Status
Address
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, H3H 1P3
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Address
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5
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Address
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, J1H 5N4
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Address
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Quebec, , G1V 4G2
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Address
Christchurch Hospital
Christchurch, , 8011
