Actively Recruiting
A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
Led by Children's Oncology Group · Updated on 2026-05-05
160
Participants Needed
166
Research Sites
440 weeks
Total Duration
On this page
Sponsors
C
Children's Oncology Group
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 3 to less than 30 years at enrollment
- Newly diagnosed localized primary CNS non-germinomatous germ cell tumor of the suprasellar and/or pineal region confirmed by pathology or elevated tumor markers
- Tumors may include suprasellar, pineal, or bifocal locations; basal ganglia or other sites excluded
- Pathological elements allowed include yolk sac tumor, embryonal carcinoma, choriocarcinoma, malignant or immature teratoma, or mixed germ cell tumor with malignant elements
- Cranial MRI with and without gadolinium before enrollment; post-operative MRI within 72 hours if surgery performed
- Spine MRI with gadolinium obtained at diagnosis or prior to enrollment
- Lumbar cerebrospinal fluid (CSF) collected prior to enrollment unless medically contraindicated
- Tumor marker review with CSF tumor markers prior to enrollment unless medically contraindicated
- Peripheral absolute neutrophil count ≥ 1000/uL within 7 days before enrollment
- Platelet count ≥ 100,000/uL (transfusion independent) within 7 days before enrollment
- Hemoglobin ≥ 8.0 g/dL within 7 days before enrollment
- Adequate kidney function measured by creatinine clearance or serum creatinine within age and gender limits
- Total bilirubin ≤ 1.5 times upper limit of normal for age within 7 days before enrollment
- Serum alanine aminotransferase (ALT) ≤ 135 U/L within 7 days before enrollment
- Controlled central nervous system function; seizure disorder allowed if well controlled on medication
- Protocol therapy must start within 31 days of surgery or diagnosis
- Written informed consent obtained from patient or guardian
- Compliance with all institutional, FDA, and NCI human study requirements
- English, Spanish, or French speaking
- No known neurodevelopmental disorders before diagnosis except NF1
- Eligibility for neuropsychological testing requires access to a site with a psychologist
You will not qualify if you...
- Tumors located outside the ventricles such as basal ganglia or thalamus
- Tumors composed only of mature teratoma with normal tumor markers
- Prior tumor-directed therapy other than surgery and corticosteroids
- Evidence of metastatic disease by MRI, CSF cytology, or surgery
- Female patients who are pregnant
- Lactating females planning to breastfeed
- Sexually active patients who do not agree to use effective contraception during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 166 locations
1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
Suspended
2
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
Actively Recruiting
3
Banner Children's at Desert
Mesa, Arizona, United States, 85202
Actively Recruiting
4
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
5
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719
Actively Recruiting
6
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States, 85719
Suspended
7
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202-3591
Actively Recruiting
8
Kaiser Permanente Downey Medical Center
Downey, California, United States, 90242
Actively Recruiting
9
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Actively Recruiting
10
Miller Children's and Women's Hospital Long Beach
Long Beach, California, United States, 90806
Actively Recruiting
11
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
12
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
Suspended
13
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
14
Valley Children's Hospital
Madera, California, United States, 93636
Actively Recruiting
15
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Actively Recruiting
16
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
17
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
18
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
Actively Recruiting
19
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
20
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
21
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Actively Recruiting
22
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
23
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
Actively Recruiting
24
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
25
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
Actively Recruiting
26
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
27
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
28
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
29
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Actively Recruiting
30
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Actively Recruiting
31
Nemours Children's Hospital
Orlando, Florida, United States, 32827
Actively Recruiting
32
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States, 32504
Actively Recruiting
33
Sacred Heart Hospital
Pensacola, Florida, United States, 32504
Suspended
34
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
Actively Recruiting
35
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, United States, 33607
Actively Recruiting
36
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
37
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Actively Recruiting
38
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States, 83712
Actively Recruiting
39
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
40
University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
41
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
42
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Actively Recruiting
43
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61637
Actively Recruiting
44
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
45
Blank Children's Hospital
Des Moines, Iowa, United States, 50309
Actively Recruiting
46
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Actively Recruiting
47
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
48
Norton Children's Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
49
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
Actively Recruiting
50
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Actively Recruiting
51
Maine Children's Cancer Program
Scarborough, Maine, United States, 04074
Actively Recruiting
52
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Actively Recruiting
53
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
54
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
55
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
56
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
57
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Actively Recruiting
58
Michigan State University
East Lansing, Michigan, United States, 48823
Active, Not Recruiting
59
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, United States, 49503
Suspended
60
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
61
Corewell Health Children's
Royal Oak, Michigan, United States, 48073
Actively Recruiting
62
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
63
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
64
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
65
University of Missouri Children's Hospital
Columbia, Missouri, United States, 65212
Actively Recruiting
66
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
67
Cardinal Glennon Children's Medical Center
St Louis, Missouri, United States, 63104
Actively Recruiting
68
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
69
Mercy Hospital Saint Louis
St Louis, Missouri, United States, 63141
Actively Recruiting
70
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States, 68114
Actively Recruiting
71
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
72
Oncology Las Vegas - Henderson
Henderson, Nevada, United States, 89074
Suspended
73
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, United States, 89135
Suspended
74
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Actively Recruiting
75
Cancer Care Specialists - Reno
Reno, Nevada, United States, 89511
Suspended
76
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
77
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
78
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Actively Recruiting
79
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
80
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
81
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Suspended
82
Saint Joseph's Regional Medical Center
Paterson, New Jersey, United States, 07503
Actively Recruiting
83
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
84
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Actively Recruiting
85
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
86
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States, 11040
Actively Recruiting
87
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Actively Recruiting
88
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
89
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
90
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
Actively Recruiting
91
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
Actively Recruiting
92
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States, 10461
Suspended
93
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467
Actively Recruiting
94
New York Medical College
Valhalla, New York, United States, 10595
Actively Recruiting
95
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Actively Recruiting
96
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
97
East Carolina University
Greenville, North Carolina, United States, 27834
Actively Recruiting
98
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
99
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
100
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Actively Recruiting
101
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
102
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States, 44106
Actively Recruiting
103
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Active, Not Recruiting
104
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
105
Dayton Children's Hospital
Dayton, Ohio, United States, 45404
Actively Recruiting
106
ProMedica Flower Hospital
Sylvania, Ohio, United States, 43560
Suspended
107
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, United States, 43606
Actively Recruiting
108
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
109
Legacy Emanuel Children's Hospital
Portland, Oregon, United States, 97227
Actively Recruiting
110
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
111
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
112
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Actively Recruiting
113
Penn State Children's Hospital
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
114
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
Actively Recruiting
115
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
116
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
117
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
118
Prisma Health Richland Hospital
Columbia, South Carolina, United States, 29203
Actively Recruiting
119
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States, 29605
Actively Recruiting
120
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States, 29605
Suspended
121
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
Actively Recruiting
122
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
123
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, United States, 37203
Actively Recruiting
124
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
125
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
Actively Recruiting
126
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
Actively Recruiting
127
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Actively Recruiting
128
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
129
El Paso Children's Hospital
El Paso, Texas, United States, 79905
Actively Recruiting
130
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
131
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
132
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
133
Children's Hospital of San Antonio
San Antonio, Texas, United States, 78207
Actively Recruiting
134
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229
Actively Recruiting
135
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
136
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
Actively Recruiting
137
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Actively Recruiting
138
University of Vermont and State Agricultural College
Burlington, Vermont, United States, 05405
Actively Recruiting
139
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
140
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States, 23507
Actively Recruiting
141
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
142
Carilion Children's
Roanoke, Virginia, United States, 24014
Actively Recruiting
143
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
144
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States, 99204
Actively Recruiting
145
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, United States, 98405
Actively Recruiting
146
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
Actively Recruiting
147
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
Actively Recruiting
148
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
149
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States, 54449
Suspended
150
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
151
The Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Actively Recruiting
152
Queensland Children's Hospital
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
153
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Actively Recruiting
154
Perth Children's Hospital
Perth, Western Australia, Australia, 6009
Actively Recruiting
155
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Actively Recruiting
156
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
157
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Actively Recruiting
158
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Actively Recruiting
159
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Actively Recruiting
160
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
Actively Recruiting
161
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Suspended
162
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, Canada, H3H 1P3
Actively Recruiting
163
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
164
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
165
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Québec, Canada, G1V 4G2
Actively Recruiting
166
Christchurch Hospital
Christchurch, New Zealand, 8011
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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