Main Menu
Main Menu
This website uses cookies that help the website function and that help us understand how you interact with it. Please read our privacy policy for more information.
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.
|
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other, NIH |
| Overall Status | 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:
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.
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
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
Suspended
Address
Children's Hospital of Alabama
Birmingham, Alabama, 35233
Status
Recruiting
Address
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Status
Recruiting
Address
Banner Children's at Desert
Mesa, Arizona, 85202
Status
Recruiting
Address
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Status
Recruiting
Address
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
Status
Suspended
Address
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719
Status
Recruiting
Address
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
Status
Recruiting
Address
Kaiser Permanente Downey Medical Center
Downey, California, 90242
Status
Recruiting
Address
Loma Linda University Medical Center
Loma Linda, California, 92354
Status
Recruiting
Address
Miller Children's and Women's Hospital Long Beach
Long Beach, California, 90806
Status
Recruiting
Address
Children's Hospital Los Angeles
Los Angeles, California, 90027
Status
Suspended
Address
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Status
Recruiting
Address
Cedars Sinai Medical Center
Los Angeles, California, 90048
Status
Recruiting
Address
Valley Children's Hospital
Madera, California, 93636
Status
Recruiting
Address
Kaiser Permanente-Oakland
Oakland, California, 94611
Status
Recruiting
Address
Children's Hospital of Orange County
Orange, California, 92868
Status
Recruiting
Address
Rady Children's Hospital - San Diego
San Diego, California, 92123
Status
Recruiting
Address
UCSF Medical Center-Mission Bay
San Francisco, California, 94158
Status
Recruiting
Address
Children's Hospital Colorado
Aurora, Colorado, 80045
Status
Recruiting
Address
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Status
Recruiting
Address
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
Status
Recruiting
Address
Children's National Medical Center
Washington, District of Columbia, 20010
Status
Recruiting
Address
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
Status
Recruiting
Address
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610
Status
Recruiting
Address
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
Status
Recruiting
Address
Nicklaus Children's Hospital
Miami, Florida, 33155
Status
Recruiting
Address
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
Status
Recruiting
Address
Nemours Children's Hospital
Orlando, Florida, 32827
Status
Recruiting
Address
Johns Hopkins All Children's Hospital
Saint Petersburg, Florida, 33701
Status
Recruiting
Address
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607
Status
Recruiting
Address
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, 30322
Status
Recruiting
Address
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Status
Recruiting
Address
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Status
Recruiting
Address
University of Illinois
Chicago, Illinois, 60612
Status
Recruiting
Address
Loyola University Medical Center
Maywood, Illinois, 60153
Status
Recruiting
Address
Saint Jude Midwest Affiliate
Peoria, Illinois, 61637
Status
Recruiting
Address
Riley Hospital for Children
Indianapolis, Indiana, 46202
Status
Recruiting
Address
Blank Children's Hospital
Des Moines, Iowa, 50309
Status
Recruiting
Address
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Status
Recruiting
Address
Norton Children's Hospital
Louisville, Kentucky, 40202
Status
Recruiting
Address
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Status
Recruiting
Address
Eastern Maine Medical Center
Bangor, Maine, 04401
Status
Recruiting
Address
Maine Children's Cancer Program
Scarborough, Maine, 04074
Status
Recruiting
Address
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Status
Recruiting
Address
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Status
Recruiting
Address
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Status
Recruiting
Address
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Status
Recruiting
Address
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
Status
Recruiting
Address
Children's Hospital of Michigan
Detroit, Michigan, 48201
Status
Recruiting
Address
Michigan State University Clinical Center
East Lansing, Michigan, 48824
Status
Suspended
Address
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Status
Recruiting
Address
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Status
Recruiting
Address
Beaumont Children's Hospital-Royal Oak
Royal Oak, Michigan, 48073
Status
Recruiting
Address
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
Status
Recruiting
Address
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Status
Recruiting
Address
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Status
Recruiting
Address
Columbia Regional
Columbia, Missouri, 65201
Status
Recruiting
Address
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Status
Recruiting
Address
Cardinal Glennon Children's Medical Center
Saint Louis, Missouri, 63104
Status
Recruiting
Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
Status
Recruiting
Address
Mercy Hospital Saint Louis
Saint Louis, Missouri, 63141
Status
Recruiting
Address
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114
Status
Recruiting
Address
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Status
Suspended
Address
GenesisCare USA - Las Vegas
Las Vegas, Nevada, 89109
Status
Recruiting
Address
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
Status
Recruiting
Address
Renown Regional Medical Center
Reno, Nevada, 89502
Status
Suspended
Address
Cancer Care Specialists - Reno
Reno, Nevada, 89511
Status
Recruiting
Address
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Status
Recruiting
Address
Morristown Medical Center
Morristown, New Jersey, 07960
Status
Recruiting
Address
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
Status
Recruiting
Address
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
Status
Recruiting
Address
Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503
Status
Recruiting
Address
Albany Medical Center
Albany, New York, 12208
Status
Suspended
Address
Montefiore Medical Center-Einstein Campus
Bronx, New York, 10461
Status
Recruiting
Address
Montefiore Medical Center - Moses Campus
Bronx, New York, 10467
Status
Recruiting
Address
Maimonides Medical Center
Brooklyn, New York, 11219
Status
Recruiting
Address
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040
Status
Recruiting
Address
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
Status
Recruiting
Address
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Status
Recruiting
Address
Stony Brook University Medical Center
Stony Brook, New York, 11794
Status
Recruiting
Address
State University of New York Upstate Medical University
Syracuse, New York, 13210
Status
Recruiting
Address
New York Medical College
Valhalla, New York, 10595
Status
Recruiting
Address
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Status
Recruiting
Address
Duke University Medical Center
Durham, North Carolina, 27710
Status
Recruiting
Address
East Carolina University
Greenville, North Carolina, 27834
Status
Recruiting
Address
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Status
Recruiting
Address
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Status
Recruiting
Address
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Status
Recruiting
Address
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Status
Recruiting
Address
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106
Status
Recruiting
Address
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Status
Recruiting
Address
Nationwide Children's Hospital
Columbus, Ohio, 43205
Status
Recruiting
Address
Dayton Children's Hospital
Dayton, Ohio, 45404
Status
Suspended
Address
ProMedica Flower Hospital
Sylvania, Ohio, 43560
Status
Recruiting
Address
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606
Status
Recruiting
Address
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Status
Recruiting
Address
Legacy Emanuel Children's Hospital
Portland, Oregon, 97227
Status
Recruiting
Address
Oregon Health and Science University
Portland, Oregon, 97239
Status
Recruiting
Address
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Status
Recruiting
Address
Geisinger Medical Center
Danville, Pennsylvania, 17822
Status
Recruiting
Address
Penn State Children's Hospital
Hershey, Pennsylvania, 17033
Status
Recruiting
Address
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Status
Recruiting
Address
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Status
Recruiting
Address
Rhode Island Hospital
Providence, Rhode Island, 02903
Status
Recruiting
Address
Medical University of South Carolina
Charleston, South Carolina, 29425
Status
Recruiting
Address
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
Status
Recruiting
Address
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605
Status
Suspended
Address
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Status
Recruiting
Address
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Status
Recruiting
Address
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105
Status
Recruiting
Address
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203
Status
Recruiting
Address
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Status
Recruiting
Address
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
Status
Recruiting
Address
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
Status
Recruiting
Address
Medical City Dallas Hospital
Dallas, Texas, 75230
Status
Recruiting
Address
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Status
Recruiting
Address
El Paso Children's Hospital
El Paso, Texas, 79905
Status
Recruiting
Address
Cook Children's Medical Center
Fort Worth, Texas, 76104
Status
Recruiting
Address
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
Status
Recruiting
Address
M D Anderson Cancer Center
Houston, Texas, 77030
Status
Recruiting
Address
Children's Hospital of San Antonio
San Antonio, Texas, 78207
Status
Recruiting
Address
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229
Status
Recruiting
Address
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Status
Recruiting
Address
Primary Children's Hospital
Salt Lake City, Utah, 84113
Status
Recruiting
Address
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
Status
Recruiting
Address
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
Status
Recruiting
Address
Carilion Children's
Roanoke, Virginia, 24014
Status
Recruiting
Address
Seattle Children's Hospital
Seattle, Washington, 98105
Status
Recruiting
Address
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
Status
Recruiting
Address
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405
Status
Recruiting
Address
Madigan Army Medical Center
Tacoma, Washington, 98431
Status
Recruiting
Address
West Virginia University Healthcare
Morgantown, West Virginia, 26506
Status
Recruiting
Address
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Status
Recruiting
Address
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Status
Recruiting
Address
The Children's Hospital at Westmead
Westmead, New South Wales, 2145
Status
Recruiting
Address
Queensland Children's Hospital
South Brisbane, Queensland, 4101
Status
Recruiting
Address
Royal Children's Hospital
Parkville, Victoria, 3052
Status
Recruiting
Address
Perth Children's Hospital
Perth, Western Australia, 6009
Status
Suspended
Address
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Status
Recruiting
Address
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Status
Recruiting
Address
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Status
Recruiting
Address
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, H3H 1P3
Status
Recruiting
Address
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5
Status
Recruiting
Address
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Quebec, , G1V 4G2
Status
Recruiting
Address
Christchurch Hospital
Christchurch, , 8011
