RECRUITING

A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2 Trial of Chemotherapy Followed by Response-Based Whole Ventricular &Amp; Spinal Canal Irradiation (WVSCI) for Patients With Localized Non-Germinomatous Central Nervous System Germ Cell Tumor

Quick Facts

Study Start:2021-07-13
Study Completion:2029-12-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04684368

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 29 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients must be \>= 3 years and \< 30 years at the time of study enrollment
  2. * 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. Suprasellar, pineal and bifocal tumors are included. (CSF tumor markers and cytology must be within 31 days prior to enrollment and start of protocol therapy \[repeat if necessary\]. Serum tumor markers, AFP and hCGbeta must be within 7 days prior to enrollment and start of protocol therapy \[repeat if necessary\]). Basal ganglia or other primary sites are excluded
  3. * 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 with only mature teratoma are excluded. Patients with pure germinoma admixed with mature teratoma are excluded (would be eligible for pure germinoma protocols)
  4. * Patients must have a cranial MRI with and without gadolinium at diagnosis/prior to enrollment. If surgical resection is performed, patients must have pre-operative and post operative brain MRI with and without gadolinium. The post operative brain MRI should be obtained within 72 hours of surgery. If patient has a biopsy only, post-operative brain MRI is recommended but not required (within 31 days prior to study enrollment and start of protocol therapy )
  5. * Patients must have a spine MRI with gadolinium obtained at diagnosis/prior to enrollment. Spine MRI with and without gadolinium is recommended (within 31 days prior to study enrollment and start of protocol therapy)
  6. * Lumbar CSF must be obtained prior to study enrollment unless medically contraindicated. If a patient undergoes surgery and lumbar CSF cytology cannot be obtained at the time of surgery, then it should be performed at least 10 days following surgery and prior to study enrollment. False positive cytology can occur within 10 days of surgery
  7. * Patients must have RAPID CENTRAL TUMOR MARKER REVIEW CSF tumor markers obtained prior to enrollment unless medically contraindicated. Ventricular CSF obtained at the time of CSF diversion procedure (if performed) is acceptable for tumor markers but lumbar CSF is preferred. In case CSF diversion and biopsy/surgery are combined, CSF tumor markers should be collected first
  8. * Peripheral absolute neutrophil count (ANC) \>= 1000/uL (within 7 days prior to enrollment)
  9. * Platelet count \>= 100,000/uL (transfusion independent) (within 7 days prior to enrollment)
  10. * Hemoglobin \>= 8.0 g/dL (may receive red blood cell \[RBC\] transfusions) (within 7 days prior to enrollment)
  11. * 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):
  12. * Age: Maximum serum creatinine (mg/dL)
  13. * 3 to \< 6 years: 0.8 (male), 0.8 (female)
  14. * 6 to \< 10 years: 1 (male), 1 (female)
  15. * 10 to \< 13 years: 1.2 (male), 1.2 (female)
  16. * 13 to \< 16 years: 1.5 (male), 1.4 (female)
  17. * \>= 16 years: male (1.7), 1.4 (female)
  18. * Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
  19. * Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L (within 7 days prior to enrollment)
  20. * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
  21. * Central nervous system function defined as:
  22. * Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
  23. * Patients must not be in status epilepticus, coma or assisted ventilation prior to study enrollment
  24. * Protocol therapy must begin within 31 calendar days of definitive surgery or clinical diagnosis, whichever is later. If a biopsy only was performed, the biopsy date will be considered the date of definitive surgery. For patients who have a biopsy or incomplete resection at diagnosis followed by additional surgery, the date of the last resection will be considered the date of definitive surgery.
  25. * All patients and/or their parents or legal guardians must sign a written informed consent
  26. * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
  27. * NEUROCOGNITIVE FUNCTION AND QUALITY OF LIFE ASSESSMENT:
  28. * English-, Spanish-, or French- speaking
  29. * 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
  30. * No known history of neurodevelopmental disorder prior to diagnosis of NGGCT (e.g., Down syndrome, fragile X, William syndrome, intellectual disability). Patients with NF1 will be allowed to participate
  31. * Additional eligibility criteria for the COG Standardized Neuropsychological Battery only: must be at a site that has a psychologist to administer the battery
  32. * 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
  1. * Patients with tumors located outside the ventricles (i.e., basal ganglia, thalamus)
  2. * Patients with only mature teratoma and non-elevated markers upon tumor sampling at diagnosis
  3. * Patients who have received any prior tumor-directed therapy for their diagnosis of NGGCT other than surgical intervention and corticosteroids
  4. * Patients with metastatic disease (i.e., MRI evaluation, lumbar CSF cytology or intraoperative evidence of dissemination)
  5. * Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs
  6. * Note: Serum and urine pregnancy tests may be falsely positive due to HCGbeta-secreting germ cell tumors. Ensure the patient is not pregnant by institutional standards
  7. * Lactating females who plan to breastfeed their infants
  8. * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation

Contacts and Locations

Principal Investigator

Shannon M MacDonald
PRINCIPAL_INVESTIGATOR
Children's Oncology Group

Study Locations (Sites)

Children's Hospital of Alabama
Birmingham, Alabama, 35233
United States
Providence Alaska Medical Center
Anchorage, Alaska, 99508
United States
Banner Children's at Desert
Mesa, Arizona, 85202
United States
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719
United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
United States
Kaiser Permanente Downey Medical Center
Downey, California, 90242
United States
Loma Linda University Medical Center
Loma Linda, California, 92354
United States
Miller Children's and Women's Hospital Long Beach
Long Beach, California, 90806
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027
United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
Valley Children's Hospital
Madera, California, 93636
United States
Kaiser Permanente-Oakland
Oakland, California, 94611
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304
United States
Rady Children's Hospital - San Diego
San Diego, California, 92123
United States
UCSF Medical Center-Mission Bay
San Francisco, California, 94158
United States
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
United States
Yale University
New Haven, Connecticut, 06520
United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
United States
Children's National Medical Center
Washington, District of Columbia, 20010
United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610
United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
United States
Nicklaus Children's Hospital
Miami, Florida, 33155
United States
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
United States
Nemours Children's Hospital
Orlando, Florida, 32827
United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32504
United States
Sacred Heart Hospital
Pensacola, Florida, 32504
United States
Johns Hopkins All Children's Hospital
Saint Petersburg, Florida, 33701
United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607
United States
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, 30329
United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
United States
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611
United States
University of Illinois
Chicago, Illinois, 60612
United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Saint Jude Midwest Affiliate
Peoria, Illinois, 61637
United States
Riley Hospital for Children
Indianapolis, Indiana, 46202
United States
Blank Children's Hospital
Des Moines, Iowa, 50309
United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
United States
Norton Children's Hospital
Louisville, Kentucky, 40202
United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
United States
Eastern Maine Medical Center
Bangor, Maine, 04401
United States
Maine Children's Cancer Program
Scarborough, Maine, 04074
United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
United States
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
Michigan State University
East Lansing, Michigan, 48823
United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
United States
Corewell Health Children's
Royal Oak, Michigan, 48073
United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
University of Missouri Children's Hospital
Columbia, Missouri, 65212
United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
United States
Cardinal Glennon Children's Medical Center
Saint Louis, Missouri, 63104
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Mercy Hospital Saint Louis
Saint Louis, Missouri, 63141
United States
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
GenesisCare USA - Las Vegas
Las Vegas, Nevada, 89109
United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
United States
Renown Regional Medical Center
Reno, Nevada, 89502
United States
Cancer Care Specialists - Reno
Reno, Nevada, 89511
United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Morristown Medical Center
Morristown, New Jersey, 07960
United States
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
United States
Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503
United States
Albany Medical Center
Albany, New York, 12208
United States
Montefiore Medical Center-Einstein Campus
Bronx, New York, 10461
United States
Montefiore Medical Center - Moses Campus
Bronx, New York, 10467
United States
Maimonides Medical Center
Brooklyn, New York, 11219
United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040
United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Stony Brook University Medical Center
Stony Brook, New York, 11794
United States
State University of New York Upstate Medical University
Syracuse, New York, 13210
United States
New York Medical College
Valhalla, New York, 10595
United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
East Carolina University
Greenville, North Carolina, 27834
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Dayton Children's Hospital
Dayton, Ohio, 45404
United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560
United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Legacy Emanuel Children's Hospital
Portland, Oregon, 97227
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822
United States
Penn State Children's Hospital
Hershey, Pennsylvania, 17033
United States
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
United States
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605
United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203
United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
United States
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
United States
Medical City Dallas Hospital
Dallas, Texas, 75230
United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
United States
El Paso Children's Hospital
El Paso, Texas, 79905
United States
Cook Children's Medical Center
Fort Worth, Texas, 76104
United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
United States
M D Anderson Cancer Center
Houston, Texas, 77030
United States
Children's Hospital of San Antonio
San Antonio, Texas, 78207
United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
United States
Primary Children's Hospital
Salt Lake City, Utah, 84113
United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
United States
Carilion Children's
Roanoke, Virginia, 24014
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
United States
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405
United States
Madigan Army Medical Center
Tacoma, Washington, 98431
United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506
United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
United States

Collaborators and Investigators

Sponsor: Children's Oncology Group

  • Shannon M MacDonald, PRINCIPAL_INVESTIGATOR, Children's Oncology Group

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-13
Study Completion Date2029-12-21

Study Record Updates

Study Start Date2021-07-13
Study Completion Date2029-12-21

Terms related to this study

Additional Relevant MeSH Terms

  • 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