Actively Recruiting

Phase 2
Age: 3Years - 29Years
All Genders
NCT04684368

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

Age: 3Years - 29Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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