- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04684368
A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
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
Study Overview
Status
Conditions
Intervention / Treatment
- Drug: Carboplatin
- Drug: Etoposide
- Drug: Ifosfamide
- Other: Questionnaire Administration
- Procedure: Magnetic Resonance Imaging
- Biological: Pegfilgrastim
- Radiation: Radiation Therapy
- Drug: Thiotepa
- Procedure: Peripheral Blood Stem Cell Transplantation
- Biological: Filgrastim
- Drug: Mesna
- Radiation: Radiation Therapy
- Procedure: Second-Look Surgery
- Procedure: Biospecimen Collection
Detailed Description
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).
SECONDARY OBJECTIVES:
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.
EXPLORATORY OBJECTIVES:
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.] proton therapy) and planned inclusion/exclusion of the vertebral body in patients < 13 years of age.
III. To compare local vs. 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.
OUTLINE:
INDUCTION CHEMOTHERAPY: Patients receive carboplatin intravenously (IV) over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of cycles 1, 3, and 5. Patients also receive ifosfamide IV over 60 minutes and etoposide IV over 60-120 minutes on days 1-5 of cycles 2, 4, and 6. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Patients are assigned to 1 of 2 plans (ventricular + spinal canal irradiation [WVSCI] or high-dose chemotherapy with peripheral stem cell rescue [HDCSCR]) based on response to induction chemotherapy:
- Patients who achieve radiographic CR/PR with marker normalization proceed to WVSCI. Patients who achieve radiographic CR without marker normalization proceed to HDCSCR.
- Patients who achieve less than radiographic CR/PR with marker normalization proceed to second-look surgery (unless contraindicated). If second-look surgery reveals mature teratoma or non-viable tumor, proceed to WVSCI. If second-look surgery reveals viable tumor, proceed to HDCSCR. Patients who are unable to undergo second-look surgery are removed from protocol therapy but remain on study for follow-up.
- Patients who achieve less than radiographic CR/PR without marker normalization proceed to second-look surgery (unless contraindicated). Patients then proceed to HDCSCR regardless of whether or not a second-look surgery is performed.
- Patients who achieve radiographic PR without marker normalization proceed to second-look surgery (unless contraindicated). Patients then proceed to HDCSCR regardless of whether or not a second-look surgery is performed.
PLAN A (WVSCI THERAPY): Within 6 weeks of the end of induction chemotherapy or second-look surgery, patients undergo WVSCI once daily (QD) for 5 days weekly (17 fractions followed by a boost dose for 13 fractions) for 6 weeks in the absence of disease progression or unacceptable toxicity.
PLAN B (CONSOLIDATION THERAPY [HDCSCR]): Within 6-8 weeks of the end of induction chemotherapy or second-look surgery, patients receive etoposide IV and thiotepa IV over 3 hours on days -5 to -3 and undergo peripheral blood stem cell (PBSC) transplant on day 0. Patients then undergo radiation therapy QD for 5 days weekly (20 fractions followed by a boost dose for 10 fractions) for 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients also undergo magnetic resonance imaging (MRI), as well as collection of cerebral spinal fluid (CSF) and blood sample throughout the trial.
After completion of study treatment, patients are followed for up to 10 years.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New South Wales
-
Westmead, New South Wales, Australia, 2145
- Recruiting
- The Children's Hospital at Westmead
-
Contact:
- Site Public Contact
- Phone Number: 61-2-9845 1400
-
Principal Investigator:
- Bhavna Padhye
-
-
Queensland
-
South Brisbane, Queensland, Australia, 4101
- Recruiting
- Queensland Children's Hospital
-
Principal Investigator:
- Steven A. Foresto
-
Contact:
- Site Public Contact
- Phone Number: 61 7 3068 1111
-
-
Victoria
-
Parkville, Victoria, Australia, 3052
- Recruiting
- Royal Children's Hospital
-
Principal Investigator:
- Dong-Anh Khuong-Quang
-
Contact:
- Site Public Contact
- Phone Number: 61 3 9345 5656
- Email: Jordan.Hansford@rch.org.au
-
-
Western Australia
-
Perth, Western Australia, Australia, 6009
- Recruiting
- Perth Children's Hospital
-
Contact:
- Site Public Contact
- Email: helpdesk@childrensoncologygroup.org
-
Principal Investigator:
- Marianne B. Phillips
-
-
-
-
-
Quebec, Canada, G1V 4G2
- Recruiting
- CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
-
Principal Investigator:
- Bruno Michon
-
Contact:
- Site Public Contact
- Phone Number: 418-525-4444
- Email: rechclinique@crchudequebec.ulaval.ca
-
-
Alberta
-
Calgary, Alberta, Canada, T3B 6A8
- Suspended
- Alberta Children's Hospital
-
Edmonton, Alberta, Canada, T6G 2B7
- Recruiting
- University of Alberta Hospital
-
Contact:
- Site Public Contact
- Phone Number: 780-407-8798
- Email: pedsoncologyresearch@ahs.ca
-
Principal Investigator:
- Sarah J. McKillop
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3E 0V9
- Recruiting
- CancerCare Manitoba
-
Contact:
- Site Public Contact
- Phone Number: 866-561-1026
- Email: ctu_web@cancercare.mb.ca
-
Principal Investigator:
- Ashley Chopek
-
-
Quebec
-
Montreal, Quebec, Canada, H3H 1P3
- Recruiting
- The Montreal Children's Hospital of the MUHC
-
Contact:
- Site Public Contact
- Phone Number: 514-412-4445
- Email: info@thechildren.com
-
Principal Investigator:
- Stephanie Mourad
-
Montreal, Quebec, Canada, H3T 1C5
- Recruiting
- Centre Hospitalier Universitaire Sainte-Justine
-
Principal Investigator:
- Monia Marzouki
-
Contact:
- Site Public Contact
- Phone Number: 514-345-4931
- Email: yvan.samson@umontreal.ca
-
-
-
-
-
Christchurch, New Zealand, 8011
- Recruiting
- Christchurch Hospital
-
Principal Investigator:
- Andrew J. Dodgshun
-
Contact:
- Site Public Contact
- Phone Number: 03 364 0640
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35233
- Suspended
- Children's Hospital of Alabama
-
-
Alaska
-
Anchorage, Alaska, United States, 99508
- Recruiting
- Providence Alaska Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 907-212-6871
- Email: AKPAMC.OncologyResearchSupport@providence.org
-
Principal Investigator:
- Brenda J. Wittman
-
-
Arizona
-
Mesa, Arizona, United States, 85202
- Recruiting
- Banner Children's at Desert
-
Contact:
- Site Public Contact
- Phone Number: 480-412-3100
-
Principal Investigator:
- Joseph C. Torkildson
-
Phoenix, Arizona, United States, 85016
- Recruiting
- Phoenix Childrens Hospital
-
Contact:
- Site Public Contact
- Phone Number: 602-546-0920
-
Principal Investigator:
- Lindsey M. Hoffman
-
Tucson, Arizona, United States, 85719
- Recruiting
- Banner University Medical Center - Tucson
-
Principal Investigator:
- Holly E. Pariury
-
Contact:
- Site Public Contact
- Email: UACC-IIT@uacc.arizona.edu
-
Tucson, Arizona, United States, 85719
- Recruiting
- University of Arizona Cancer Center-North Campus
-
Principal Investigator:
- Holly E. Pariury
-
Contact:
- Site Public Contact
- Email: UACC-IIT@uacc.arizona.edu
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72202-3591
- Recruiting
- Arkansas Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 501-364-7373
-
Principal Investigator:
- David L. Becton
-
-
California
-
Downey, California, United States, 90242
- Recruiting
- Kaiser Permanente Downey Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 626-564-3455
-
Principal Investigator:
- Hung N. Tran
-
Loma Linda, California, United States, 92354
- Recruiting
- Loma Linda University Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 909-558-4050
-
Principal Investigator:
- Albert Kheradpour
-
Long Beach, California, United States, 90806
- Recruiting
- Miller Children's and Women's Hospital Long Beach
-
Contact:
- Site Public Contact
- Phone Number: 562-933-5600
-
Principal Investigator:
- Jacqueline N. Casillas
-
Los Angeles, California, United States, 90027
- Recruiting
- Children's Hospital Los Angeles
-
Contact:
- Site Public Contact
- Phone Number: 323-361-4110
-
Principal Investigator:
- Tom B. Davidson
-
Los Angeles, California, United States, 90048
- Recruiting
- Cedars Sinai Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 310-423-8965
-
Principal Investigator:
- Fataneh (Fae) Majlessipour
-
Los Angeles, California, United States, 90027
- Recruiting
- Kaiser Permanente Los Angeles Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Principal Investigator:
- Hung N. Tran
-
Madera, California, United States, 93636
- Recruiting
- Valley Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 559-353-3000
- Email: Research@valleychildrens.org
-
Principal Investigator:
- Karen S. Fernandez
-
Oakland, California, United States, 94611
- Recruiting
- Kaiser Permanente-Oakland
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Aarati V. Rao
-
Orange, California, United States, 92868
- Recruiting
- Children's Hospital of Orange County
-
Contact:
- Site Public Contact
- Phone Number: 714-509-8646
- Email: oncresearch@choc.org
-
Principal Investigator:
- Elyssa M. Rubin
-
San Diego, California, United States, 92123
- Recruiting
- Rady Children's Hospital - San Diego
-
Contact:
- Site Public Contact
- Phone Number: 858-966-5934
-
Principal Investigator:
- William D. Roberts
-
San Francisco, California, United States, 94158
- Recruiting
- UCSF Medical Center-Mission Bay
-
Contact:
- Site Public Contact
- Phone Number: 877-827-3222
- Email: cancertrials@ucsf.edu
-
Principal Investigator:
- Alyssa T. Reddy
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- Children's Hospital Colorado
-
Contact:
- Site Public Contact
- Phone Number: 303-764-5056
- Email: josh.b.gordon@nsmtp.kp.org
-
Principal Investigator:
- Kathleen M. Dorris
-
-
Connecticut
-
Hartford, Connecticut, United States, 06106
- Recruiting
- Connecticut Children's Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 860-545-9981
-
Principal Investigator:
- Michael S. Isakoff
-
-
Delaware
-
Wilmington, Delaware, United States, 19803
- Recruiting
- Alfred I duPont Hospital for Children
-
Contact:
- Site Public Contact
- Phone Number: 302-651-5572
- Email: Allison.bruce@nemours.org
-
Principal Investigator:
- Scott M. Bradfield
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
- Recruiting
- Children's National Medical Center
-
Principal Investigator:
- Jeffrey S. Dome
-
Contact:
- Site Public Contact
- Phone Number: 202-476-2800
- Email: OncCRC_OnCall@childrensnational.org
-
-
Florida
-
Fort Myers, Florida, United States, 33908
- Recruiting
- Golisano Children's Hospital of Southwest Florida
-
Contact:
- Site Public Contact
- Phone Number: 239-343-5333
- Email: molly.arnstrom@leehealth.org
-
Principal Investigator:
- Emad K. Salman
-
Gainesville, Florida, United States, 32610
- Recruiting
- University of Florida Health Science Center - Gainesville
-
Contact:
- Site Public Contact
- Phone Number: 352-273-8010
- Email: cancer-center@ufl.edu
-
Principal Investigator:
- William B. Slayton
-
Jacksonville, Florida, United States, 32207
- Recruiting
- Nemours Children's Clinic-Jacksonville
-
Contact:
- Site Public Contact
- Phone Number: 302-651-5572
- Email: Allison.bruce@nemours.org
-
Principal Investigator:
- Scott M. Bradfield
-
Miami, Florida, United States, 33155
- Recruiting
- Nicklaus Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 888-624-2778
-
Principal Investigator:
- Ziad A. Khatib
-
Orlando, Florida, United States, 32806
- Recruiting
- Arnold Palmer Hospital for Children
-
Contact:
- Site Public Contact
- Phone Number: 321-841-5357
- Email: Jennifer.spinelli@orlandohealth.com
-
Principal Investigator:
- Amy A. Smith
-
Orlando, Florida, United States, 32827
- Recruiting
- Nemours Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 302-651-5572
- Email: Allison.bruce@nemours.org
-
Principal Investigator:
- Scott M. Bradfield
-
Saint Petersburg, Florida, United States, 33701
- Recruiting
- Johns Hopkins All Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 727-767-4784
- Email: Ashley.Repp@jhmi.edu
-
Principal Investigator:
- Stacie L. Stapleton
-
Tampa, Florida, United States, 33607
- Recruiting
- Saint Joseph's Hospital/Children's Hospital-Tampa
-
Contact:
- Site Public Contact
- Phone Number: 813-357-0849
- Email: jennifer.manns@baycare.org
-
Principal Investigator:
- Don E. Eslin
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Recruiting
- Children's Healthcare of Atlanta - Egleston
-
Contact:
- Site Public Contact
- Phone Number: 404-785-2025
- Email: Leann.Schilling@choa.org
-
Principal Investigator:
- Jason R. Fangusaro
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96826
- Recruiting
- Kapiolani Medical Center for Women and Children
-
Contact:
- Site Public Contact
- Phone Number: 808-983-6090
-
Principal Investigator:
- Wade T. Kyono
-
-
Idaho
-
Boise, Idaho, United States, 83712
- Recruiting
- Saint Luke's Cancer Institute - Boise
-
Principal Investigator:
- Martha M. Pacheco
-
Contact:
- Site Public Contact
- Phone Number: 208-381-2774
- Email: eslinget@slhs.org
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Recruiting
- University of Illinois
-
Contact:
- Site Public Contact
- Phone Number: 312-355-3046
-
Principal Investigator:
- Dipti S. Dighe
-
Maywood, Illinois, United States, 60153
- Recruiting
- Loyola University Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 708-226-4357
-
Principal Investigator:
- Eugene Suh
-
Peoria, Illinois, United States, 61637
- Recruiting
- Saint Jude Midwest Affiliate
-
Contact:
- Site Public Contact
- Phone Number: 888-226-4343
-
Principal Investigator:
- Prerna Kumar
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Recruiting
- Riley Hospital for Children
-
Contact:
- Sandeep Batra
- Phone Number: 317-944-8784
- Email: batras@iu.edu
-
Principal Investigator:
- Sandeep Batra
-
-
Iowa
-
Des Moines, Iowa, United States, 50309
- Recruiting
- Blank Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 515-241-8912
- Email: samantha.mallory@unitypoint.org
-
Principal Investigator:
- Samantha L. Mallory
-
Iowa City, Iowa, United States, 52242
- Recruiting
- University of Iowa/Holden Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-237-1225
-
Principal Investigator:
- David S. Dickens
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- Recruiting
- Norton Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 502-629-5500
- Email: CancerResource@nortonhealthcare.org
-
Principal Investigator:
- Ashok B. Raj
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70121
- Recruiting
- Ochsner Medical Center Jefferson
-
Contact:
- Site Public Contact
- Phone Number: 504-842-8084
- Email: Elisemarie.curry@ochsner.org
-
Principal Investigator:
- Craig Lotterman
-
-
Maine
-
Bangor, Maine, United States, 04401
- Recruiting
- Eastern Maine Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 207-973-4274
-
Principal Investigator:
- Daniel L. Callaway
-
Scarborough, Maine, United States, 04074
- Recruiting
- Maine Children's Cancer Program
-
Contact:
- Site Public Contact
- Phone Number: 207-396-7581
- Email: sverwys@mmc.org
-
Principal Investigator:
- Stanley Chaleff
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Recruiting
- Johns Hopkins University/Sidney Kimmel Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 410-955-8804
- Email: jhcccro@jhmi.edu
-
Principal Investigator:
- Kenneth J. Cohen
-
Baltimore, Maryland, United States, 21215
- Recruiting
- Sinai Hospital of Baltimore
-
Contact:
- Site Public Contact
- Phone Number: 410-601-6120
- Email: pridgely@lifebridgehealth.org
-
Principal Investigator:
- Jason M. Fixler
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital Cancer Center
-
Principal Investigator:
- Shannon M. MacDonald
-
Contact:
- Site Public Contact
- Phone Number: 877-726-5130
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Dana-Farber Cancer Institute
-
Principal Investigator:
- Kee Kiat Yeo
-
Contact:
- Site Public Contact
- Phone Number: 877-442-3324
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Recruiting
- C S Mott Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 800-865-1125
-
Principal Investigator:
- Andrea T. Franson
-
Detroit, Michigan, United States, 48201
- Recruiting
- Children's Hospital of Michigan
-
Principal Investigator:
- Stephanie A. Toll
-
Contact:
- Site Public Contact
- Email: helpdesk@childrensoncologygroup.org
-
East Lansing, Michigan, United States, 48824
- Recruiting
- Michigan State University Clinical Center
-
Contact:
- Site Public Contact
- Phone Number: 517-975-9547
-
Principal Investigator:
- Laura E. Agresta
-
Grand Rapids, Michigan, United States, 49503
- Recruiting
- Helen DeVos Children's Hospital at Spectrum Health
-
Principal Investigator:
- Kathleen J. Yost
-
Contact:
- Site Public Contact
- Phone Number: 616-267-1925
- Email: crcwm-regulatory@crcwm.org
-
Grand Rapids, Michigan, United States, 49503
- Recruiting
- Spectrum Health at Butterworth Campus
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen J. Yost
-
Royal Oak, Michigan, United States, 48073
- Recruiting
- Beaumont Children's Hospital-Royal Oak
-
Contact:
- Site Public Contact
- Phone Number: 248-551-7695
-
Principal Investigator:
- Laura K. Gowans
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55404
- Recruiting
- Children's Hospitals and Clinics of Minnesota - Minneapolis
-
Principal Investigator:
- Michael K. Richards
-
Contact:
- Site Public Contact
- Phone Number: 612-813-5913
- Email: pauline.mitby@childrensmn.org
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Rochester
-
Contact:
- Site Public Contact
- Phone Number: 855-776-0015
-
Principal Investigator:
- Jonathan D. Schwartz
-
-
Mississippi
-
Jackson, Mississippi, United States, 39216
- Recruiting
- University of Mississippi Medical Center
-
Principal Investigator:
- Betty L. Herrington
-
Contact:
- Site Public Contact
- Phone Number: 601-815-6700
-
-
Missouri
-
Columbia, Missouri, United States, 65201
- Recruiting
- Columbia Regional
-
Contact:
- Site Public Contact
- Email: helpdesk@childrensoncologygroup.org
-
Principal Investigator:
- Barbara A. Gruner
-
Kansas City, Missouri, United States, 64108
- Recruiting
- Children's Mercy Hospitals and Clinics
-
Contact:
- Site Public Contact
- Phone Number: 816-302-6808
- Email: rryan@cmh.edu
-
Principal Investigator:
- Keith J. August
-
Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine
-
Principal Investigator:
- Mohamed S. Abdelbaki
-
Contact:
- Site Public Contact
- Phone Number: 800-600-3606
- Email: info@siteman.wustl.edu
-
Saint Louis, Missouri, United States, 63104
- Recruiting
- Cardinal Glennon Children's Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 314-268-4000
-
Principal Investigator:
- William S. Ferguson
-
Saint Louis, Missouri, United States, 63141
- Recruiting
- Mercy Hospital Saint Louis
-
Contact:
- Site Public Contact
- Phone Number: 314-251-7066
-
Principal Investigator:
- Robin D. Hanson
-
-
Nebraska
-
Omaha, Nebraska, United States, 68114
- Recruiting
- Children's Hospital and Medical Center of Omaha
-
Contact:
- Site Public Contact
- Phone Number: 402-955-3949
-
Principal Investigator:
- Jill C. Beck
-
Omaha, Nebraska, United States, 68198
- Recruiting
- University of Nebraska Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 402-559-6941
- Email: unmcrsa@unmc.edu
-
Principal Investigator:
- Jill C. Beck
-
-
Nevada
-
Las Vegas, Nevada, United States, 89109
- Recruiting
- GenesisCare USA - Las Vegas
-
Contact:
- Site Public Contact
- Phone Number: 702-384-0013
- Email: research@sncrf.org
-
Principal Investigator:
- Alan K. Ikeda
-
Las Vegas, Nevada, United States, 89135
- Recruiting
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
-
Contact:
- Site Public Contact
- Phone Number: 702-384-0013
- Email: research@sncrf.org
-
Principal Investigator:
- Alan K. Ikeda
-
Reno, Nevada, United States, 89502
- Recruiting
- Renown Regional Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 702-384-0013
- Email: research@sncrf.org
-
Principal Investigator:
- Alan K. Ikeda
-
Reno, Nevada, United States, 89511
- Suspended
- Cancer Care Specialists - Reno
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Recruiting
- Hackensack University Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 201-996-2879
-
Principal Investigator:
- Derek R. Hanson
-
Morristown, New Jersey, United States, 07960
- Recruiting
- Morristown Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 973-971-5900
-
Principal Investigator:
- Kathryn L. Laurie
-
New Brunswick, New Jersey, United States, 08901
- Recruiting
- Saint Peter's University Hospital
-
Contact:
- Site Public Contact
- Phone Number: 6163 732-745-8600
- Email: kcovert@saintpetersuh.com
-
Principal Investigator:
- Nibal A. Zaghloul
-
New Brunswick, New Jersey, United States, 08903
- Recruiting
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
-
Principal Investigator:
- Scott Moerdler
-
Contact:
- Site Public Contact
- Phone Number: 732-235-8675
-
Paterson, New Jersey, United States, 07503
- Recruiting
- Saint Joseph's Regional Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 973-754-2207
- Email: HallL@sjhmc.org
-
Principal Investigator:
- Alissa Kahn
-
-
New York
-
Albany, New York, United States, 12208
- Recruiting
- Albany Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 518-262-5513
-
Principal Investigator:
- Lauren R. Weintraub
-
Bronx, New York, United States, 10461
- Recruiting
- Montefiore Medical Center-Einstein Campus
-
Contact:
- Site Public Contact
- Phone Number: 718-379-6866
- Email: eskwak@montefiore.org
-
Principal Investigator:
- Alice Lee
-
Bronx, New York, United States, 10467
- Recruiting
- Montefiore Medical Center - Moses Campus
-
Contact:
- Site Public Contact
- Phone Number: 718-379-6866
- Email: eskwak@montefiore.org
-
Principal Investigator:
- Alice Lee
-
Brooklyn, New York, United States, 11219
- Recruiting
- Maimonides Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 718-765-2500
-
Principal Investigator:
- Mahmut Y. Celiker
-
New Hyde Park, New York, United States, 11040
- Recruiting
- The Steven and Alexandra Cohen Children's Medical Center of New York
-
Contact:
- Site Public Contact
- Phone Number: 718-470-3460
-
Principal Investigator:
- Mark P. Atlas
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 212-639-7592
-
Principal Investigator:
- Sameer Farouk Sait
-
New York, New York, United States, 10016
- Recruiting
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
-
Contact:
- Site Public Contact
- Email: CancerTrials@nyulangone.org
-
Principal Investigator:
- Sharon L. Gardner
-
Stony Brook, New York, United States, 11794
- Recruiting
- Stony Brook University Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 800-862-2215
-
Principal Investigator:
- Laura E. Hogan
-
Syracuse, New York, United States, 13210
- Recruiting
- State University of New York Upstate Medical University
-
Contact:
- Site Public Contact
- Phone Number: 315-464-5476
-
Principal Investigator:
- Philip M. Monteleone
-
Valhalla, New York, United States, 10595
- Recruiting
- New York Medical College
-
Contact:
- Site Public Contact
- Phone Number: 914-594-3794
-
Principal Investigator:
- Jessica C. Hochberg
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28203
- Recruiting
- Carolinas Medical Center/Levine Cancer Institute
-
Contact:
- Site Public Contact
- Phone Number: 800-804-9376
-
Principal Investigator:
- Joel A. Kaplan
-
Durham, North Carolina, United States, 27710
- Recruiting
- Duke University Medical Center
-
Principal Investigator:
- Jessica M. Sun
-
Contact:
- Site Public Contact
- Phone Number: 888-275-3853
-
Greenville, North Carolina, United States, 27834
- Recruiting
- East Carolina University
-
Contact:
- Site Public Contact
- Phone Number: 252-744-1015
- Email: eubankss@ecu.edu
-
Principal Investigator:
- Andrea R. Whitfield
-
Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Wake Forest University Health Sciences
-
Contact:
- Site Public Contact
- Phone Number: 336-713-6771
-
Principal Investigator:
- Thomas W. McLean
-
-
North Dakota
-
Fargo, North Dakota, United States, 58122
- Recruiting
- Sanford Broadway Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 701-323-5760
- Email: OncologyClinicalTrialsFargo@sanfordhealth.org
-
Principal Investigator:
- Samuel J. Milanovich
-
-
Ohio
-
Akron, Ohio, United States, 44308
- Recruiting
- Children's Hospital Medical Center of Akron
-
Contact:
- Site Public Contact
- Phone Number: 330-543-3193
-
Principal Investigator:
- Erin Wright
-
Cincinnati, Ohio, United States, 45229
- Recruiting
- Cincinnati Children's Hospital Medical Center
-
Principal Investigator:
- Trent R. Hummel
-
Contact:
- Site Public Contact
- Phone Number: 513-636-2799
- Email: cancer@cchmc.org
-
Cleveland, Ohio, United States, 44195
- Recruiting
- Cleveland Clinic Foundation
-
Contact:
- Site Public Contact
- Phone Number: 866-223-8100
- Email: TaussigResearch@ccf.org
-
Principal Investigator:
- Rabi Hanna
-
Cleveland, Ohio, United States, 44106
- Recruiting
- Rainbow Babies and Childrens Hospital
-
Contact:
- Site Public Contact
- Phone Number: 216-844-5437
-
Principal Investigator:
- Duncan S. Stearns
-
Columbus, Ohio, United States, 43205
- Recruiting
- Nationwide Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 614-722-6039
- Email: Melinda.Triplet@nationwidechildrens.org
-
Principal Investigator:
- Mark A. Ranalli
-
Dayton, Ohio, United States, 45404
- Recruiting
- Dayton Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 800-228-4055
-
Principal Investigator:
- Mukund G. Dole
-
Sylvania, Ohio, United States, 43560
- Recruiting
- ProMedica Flower Hospital
-
Contact:
- Site Public Contact
- Phone Number: 419-824-1842
- Email: PCIOncResearch@promedica.org
-
Principal Investigator:
- Jamie L. Dargart
-
Toledo, Ohio, United States, 43606
- Recruiting
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 419-824-1842
- Email: PCIOncResearch@promedica.org
-
Principal Investigator:
- Jamie L. Dargart
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- University of Oklahoma Health Sciences Center
-
Contact:
- Site Public Contact
- Phone Number: 405-271-8777
- Email: ou-clinical-trials@ouhsc.edu
-
Principal Investigator:
- Rene Y. McNall-Knapp
-
-
Oregon
-
Portland, Oregon, United States, 97227
- Recruiting
- Legacy Emanuel Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 503-413-2560
-
Principal Investigator:
- Janice F. Olson
-
Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health and Science University
-
Contact:
- Site Public Contact
- Phone Number: 503-494-1080
- Email: trials@ohsu.edu
-
Principal Investigator:
- Linda C. Stork
-
-
Pennsylvania
-
Allentown, Pennsylvania, United States, 18103
- Recruiting
- Lehigh Valley Hospital-Cedar Crest
-
Contact:
- Site Public Contact
- Phone Number: 610-402-9543
- Email: Morgan_M.Horton@lvhn.org
-
Principal Investigator:
- Jacob A. Troutman
-
Danville, Pennsylvania, United States, 17822
- Recruiting
- Geisinger Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 570-271-5251
- Email: HemonCCTrials@geisinger.edu
-
Principal Investigator:
- Jagadeesh Ramdas
-
Hershey, Pennsylvania, United States, 17033
- Recruiting
- Penn State Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 717-531-6012
-
Principal Investigator:
- Lisa M. McGregor
-
Philadelphia, Pennsylvania, United States, 19134
- Recruiting
- Saint Christopher's Hospital for Children
-
Contact:
- Site Public Contact
- Phone Number: 215-427-8991
-
Principal Investigator:
- Gregory E. Halligan
-
Pittsburgh, Pennsylvania, United States, 15224
- Recruiting
- Children's Hospital of Pittsburgh of UPMC
-
Contact:
- Site Public Contact
- Phone Number: 412-692-8570
- Email: jean.tersak@chp.edu
-
Principal Investigator:
- James T. Felker
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Recruiting
- Rhode Island Hospital
-
Contact:
- Site Public Contact
- Phone Number: 401-444-1488
-
Principal Investigator:
- Jennifer J. Welch
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Recruiting
- Medical University of South Carolina
-
Contact:
- Site Public Contact
- Phone Number: 843-792-9321
- Email: hcc-clinical-trials@musc.edu
-
Principal Investigator:
- Jacqueline M. Kraveka
-
Columbia, South Carolina, United States, 29203
- Recruiting
- Prisma Health Richland Hospital
-
Contact:
- Site Public Contact
- Phone Number: 864-241-6251
-
Principal Investigator:
- Stuart L. Cramer
-
Greenville, South Carolina, United States, 29605
- Recruiting
- BI-LO Charities Children's Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 864-241-6251
-
Principal Investigator:
- Aniket Saha
-
Greenville, South Carolina, United States, 29605
- Recruiting
- Prisma Health Cancer Institute - Faris
-
Contact:
- Site Public Contact
- Phone Number: 864-241-6251
-
Principal Investigator:
- Aniket Saha
-
-
South Dakota
-
Sioux Falls, South Dakota, United States, 57117-5134
- Recruiting
- Sanford USD Medical Center - Sioux Falls
-
Contact:
- Site Public Contact
- Phone Number: 605-312-3320
- Email: OncologyClinicalTrialsSF@SanfordHealth.org
-
Principal Investigator:
- Kayelyn J. Wagner
-
-
Tennessee
-
Memphis, Tennessee, United States, 38105
- Recruiting
- Saint Jude Children's Research Hospital
-
Principal Investigator:
- Aditi Bagchi
-
Contact:
- Site Public Contact
- Phone Number: 888-226-4343
- Email: referralinfo@stjude.org
-
Nashville, Tennessee, United States, 37232
- Recruiting
- Vanderbilt University/Ingram Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-811-8480
-
Principal Investigator:
- Adam J. Esbenshade
-
Nashville, Tennessee, United States, 37203
- Recruiting
- The Children's Hospital at TriStar Centennial
-
Contact:
- Site Public Contact
- Phone Number: 615-342-1919
-
Principal Investigator:
- Jennifer A. Domm
-
-
Texas
-
Austin, Texas, United States, 78723
- Recruiting
- Dell Children's Medical Center of Central Texas
-
Contact:
- Site Public Contact
- Phone Number: 512-628-1902
- Email: TXAUS-DL-SFCHemonc.research@ascension.org
-
Principal Investigator:
- Shannon M. Cohn
-
Corpus Christi, Texas, United States, 78411
- Recruiting
- Driscoll Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 361-694-5311
- Email: Crystal.DeLosSantos@dchstx.org
-
Principal Investigator:
- Nkechi I. Mba
-
Dallas, Texas, United States, 75390
- Recruiting
- UT Southwestern/Simmons Cancer Center-Dallas
-
Contact:
- Daniel C. Bowers
- Phone Number: 214-648-3896
- Email: Daniel.Bowers@utsouthwestern.edu
-
Principal Investigator:
- Daniel C. Bowers
-
Dallas, Texas, United States, 75230
- Recruiting
- Medical City Dallas Hospital
-
Contact:
- Site Public Contact
- Phone Number: 972-566-5588
-
Principal Investigator:
- Stanton C. Goldman
-
El Paso, Texas, United States, 79905
- Recruiting
- El Paso Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 915-298-5444
- Email: ranjan.bista@ttuhsc.edu
-
Principal Investigator:
- Benjamin Carcamo
-
Fort Worth, Texas, United States, 76104
- Recruiting
- Cook Children's Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 682-885-2103
- Email: CookChildrensResearch@cookchildrens.org
-
Principal Investigator:
- Sibo Zhao
-
Houston, Texas, United States, 77030
- Recruiting
- M D Anderson Cancer Center
-
Contact:
- Najat C. Daw
- Phone Number: 713-792-6315
- Email: ndaw@mdanderson.org
-
Principal Investigator:
- Najat C. Daw
-
Houston, Texas, United States, 77030
- Recruiting
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
-
Principal Investigator:
- Jack M. Su
-
Contact:
- Site Public Contact
- Phone Number: 713-798-1354
- Email: burton@bcm.edu
-
San Antonio, Texas, United States, 78207
- Recruiting
- Children's Hospital of San Antonio
-
Contact:
- Site Public Contact
- Phone Number: 210-704-2894
- Email: bridget.medina@christushealth.org
-
Principal Investigator:
- Timothy C. Griffin
-
San Antonio, Texas, United States, 78229
- Recruiting
- University of Texas Health Science Center at San Antonio
-
Contact:
- Site Public Contact
- Phone Number: 210-450-3800
- Email: phoresearchoffice@uthscsa.edu
-
Principal Investigator:
- Shafqat Shah
-
San Antonio, Texas, United States, 78229
- Recruiting
- Methodist Children's Hospital of South Texas
-
Contact:
- Site Public Contact
- Phone Number: 210-575-6240
- Email: Vinod.GidvaniDiaz@hcahealthcare.com
-
Principal Investigator:
- Jose M. Esquilin
-
-
Utah
-
Salt Lake City, Utah, United States, 84113
- Recruiting
- Primary Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 801-585-5270
-
Principal Investigator:
- Priya Chan
-
-
Virginia
-
Norfolk, Virginia, United States, 23507
- Recruiting
- Children's Hospital of The King's Daughters
-
Contact:
- Site Public Contact
- Phone Number: 757-668-7243
- Email: CCBDCresearch@chkd.org
-
Principal Investigator:
- Eric J. Lowe
-
Richmond, Virginia, United States, 23298
- Recruiting
- Virginia Commonwealth University/Massey Cancer Center
-
Contact:
- Site Public Contact
- Email: CTOclinops@vcu.edu
-
Principal Investigator:
- Frances Austin
-
Roanoke, Virginia, United States, 24014
- Recruiting
- Carilion Children's
-
Contact:
- Site Public Contact
- Phone Number: 540-266-6238
- Email: wpmccarty@carilionclinic.org
-
Principal Investigator:
- Erwood G. Edwards
-
-
Washington
-
Seattle, Washington, United States, 98105
- Recruiting
- Seattle Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 866-987-2000
-
Principal Investigator:
- Sarah E. Leary
-
Spokane, Washington, United States, 99204
- Recruiting
- Providence Sacred Heart Medical Center and Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 800-228-6618
- Email: HopeBeginsHere@providence.org
-
Principal Investigator:
- Judy L. Felgenhauer
-
Tacoma, Washington, United States, 98405
- Recruiting
- Mary Bridge Children's Hospital and Health Center
-
Contact:
- Site Public Contact
- Phone Number: 253-403-1461
- Email: research@multicare.org
-
Principal Investigator:
- Robert G. Irwin
-
Tacoma, Washington, United States, 98431
- Recruiting
- Madigan Army Medical Center
-
Principal Investigator:
- Melissa A. Forouhar
-
Contact:
- Site Public Contact
- Phone Number: 253-968-6144
- Email: melissa.a.forouhar.mil@health.mil
-
-
West Virginia
-
Morgantown, West Virginia, United States, 26506
- Recruiting
- West Virginia University Healthcare
-
Contact:
- Site Public Contact
- Phone Number: 304-293-7374
- Email: cancertrialsinfo@hsc.wvu.edu
-
Principal Investigator:
- Ashley E. Meyer
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- Recruiting
- University of Wisconsin Carbone Cancer Center
-
Principal Investigator:
- Kenneth B. De Santes
-
Contact:
- Site Public Contact
- Phone Number: 800-622-8922
- Email: clinicaltrials@cancer.wisc.edu
-
Marshfield, Wisconsin, United States, 54449
- Recruiting
- Marshfield Medical Center-Marshfield
-
Contact:
- Site Public Contact
- Phone Number: 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
Principal Investigator:
- Jon M. Brandt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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. 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
- 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)
- 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 )
- 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)
- 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
- 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
- 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. 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.
- 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). Patients with NF1 will be allowed to participate
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. Ensure the patient is not pregnant by institutional standards
- Lactating females who plan to breastfeed their infants
- Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Plan A (chemotherapy, WVSCI, second-look surgery if needed)
See Outline in Detailed Description.
|
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Ancillary studies
Undergo MRI
Other Names:
Given SC
Other Names:
Undergo radiation therapy
Other Names:
Given subcutaneously (SC) or IV
Other Names:
Given IV or orally
Other Names:
Undergo WVSCI radiation therapy
Other Names:
Undergo second-look surgery if needed
Other Names:
Undergo collection of CSF and blood samples
Other Names:
|
Experimental: Plan B (chemotherapy, HDCSCR, second-look surgery if needed)
See Outline in Detailed Description.
|
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Ancillary studies
Undergo MRI
Other Names:
Given SC
Other Names:
Undergo radiation therapy
Other Names:
Given IV
Other Names:
Undergo PBSC transplant
Other Names:
Given subcutaneously (SC) or IV
Other Names:
Given IV or orally
Other Names:
Undergo WVSCI radiation therapy
Other Names:
Undergo second-look surgery if needed
Other Names:
Undergo collection of CSF and blood samples
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Failure rate
Time Frame: Within 2 years of enrollment
|
Will be measured by the number of progressions or deaths within 2 years of enrollment for the cohort treated with whole ventricular + spinal canal irradiation (WVSCI).
The final analysis will include an exact binomial confidence interval of the failure rate for each of the failure types (local, distant/spinal or both) without adjustment for multiplicity.
|
Within 2 years of enrollment
|
Spinal failure rate
Time Frame: Within 2 years of enrollment
|
Will be measured by the number of spinal relapses (spine alone or distant relapses including the spine) within 2 years of enrollment in patients treated with WVSCI.
The final analysis will include an exact binomial confidence interval of spinal failure rate.
|
Within 2 years of enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: From enrollment until disease progression or death from any cause for patients with events, and until final follow up for those who are event free at the time of analysis, assessed up to 10 years
|
Will be estimated separately for those treated with WVSCI and with HDCSCR + radiation therapy.
Kaplan-Maier based PFS curve estimates will be included, where patients who are lost to follow up will be treated as censored observations as part of the primary analyses.
|
From enrollment until disease progression or death from any cause for patients with events, and until final follow up for those who are event free at the time of analysis, assessed up to 10 years
|
Overall survival (OS)
Time Frame: From enrollment until death from any cause for patients with events and until final follow up for those who are alive at the time of analysis, assessed up to 10 years
|
Will be estimated separately for those treated with WVSCI and with HDCSCR + radiation therapy.
Kaplan-Maier based OS curve estimates will be included, where patients who are lost to follow up will be treated as censored observations as part of the secondary analyses.
|
From enrollment until death from any cause for patients with events and until final follow up for those who are alive at the time of analysis, assessed up to 10 years
|
Patterns of disease recurrence/failure
Time Frame: Up to 10 years
|
Will be analyzed in an exploratory manner with respect to radiation dose distribution.
|
Up to 10 years
|
Radiographic complete response (CR)/partial response (PR) with marker normalization rate post induction/second-look surgery
Time Frame: Approximately 6 to 9 months post-treatment initiation
|
Will be assessed in patients treated with induction chemotherapy.
Will be estimated using an exact binomial approach and its confidence interval.
|
Approximately 6 to 9 months post-treatment initiation
|
Radiographic complete response (CR)/partial response (PR) with marker normalization rate post high-dose chemotherapy with peripheral stem cell rescue (HDCSCR)
Time Frame: Up to 2 years post-treatment initiation
|
Will be assessed in patients treated with HDCSCR.
Will be estimated using an exact binomial approach and its confidence interval.
|
Up to 2 years post-treatment initiation
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in intelligence scores within each treatment arm
Time Frame: Baseline up to 60 months post-treatment initiation
|
Will be assessed by the Wechsler Preschool and Primary Scale of Intelligence 4th Edition (WPPSI-IV), Wechsler Intelligence Scale for Children 5th Edition (WISC-V), and the Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV), depending on patient's age.
One-sample confidence intervals will be used to estimate mean pairwise changes in intelligence scores between 2 time points within each treatment arm.
|
Baseline up to 60 months post-treatment initiation
|
Change in intelligence scores between treatment arms
Time Frame: Baseline up to 60 months post-treatment initiation
|
Will be assessed by the Wechsler Preschool and Primary Scale of Intelligence 4th Edition (WPPSI- IV), Wechsler Intelligence Scale for Children 5th Edition (WISC V), and the Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV), depending on patient's age.
A 2-sample confidence interval approach will be used to estimate the difference in score changes between the two cohorts (WVSCI versus HDCSCR) in order to describe differential effects of the 2 treatment strategies.
|
Baseline up to 60 months post-treatment initiation
|
Change in processing speed/attention within each treatment arm
Time Frame: Baseline up to 60 months post-treatment initiation
|
Will be assessed by the WISC-V or WAIS-IV processing speed index tasks.
One-sample confidence intervals will be used to estimate mean pairwise changes in scores between 2 time points within each treatment arm.
|
Baseline up to 60 months post-treatment initiation
|
Change in processing speed/attention between the two treatment arms
Time Frame: Baseline up to 60 months post-treatment initiation
|
Will be assessed by the WISC-V or WAIS-IV processing speed index tasks.
A 2-sample confidence interval approach will be used to estimate the difference in score changes between the two cohorts (WVSCI versus HDCSCR) in order to describe differential effects of the 2 treatment strategies.
|
Baseline up to 60 months post-treatment initiation
|
Change in immediate visual memory within each arm
Time Frame: Baseline up to 60 months post-treatment initiation
|
Will be assessed by the Children's Memory Scale and California Verbal Learning Test.
One-sample confidence intervals will be used to estimate mean pairwise changes in scores between 2 time points within treatment arms, as appropriate.
|
Baseline up to 60 months post-treatment initiation
|
Change in social-emotional functioning within each arm
Time Frame: Baseline up to 60 months post-treatment initiation
|
Will be assessed by the Behavior Assessment System for Children - 3rd Edition.
One-sample confidence intervals will be used to estimate mean pairwise changes in scores between 2 time points within treatment arms, as appropriate.
|
Baseline up to 60 months post-treatment initiation
|
Change in adaptive functioning within each arm
Time Frame: Baseline up to 60 months post-treatment initiation
|
Will be assessed by the Adaptive Behavior Assessment System - 3rd Edition.
One-sample confidence intervals will be used to estimate mean pairwise changes in scores between 2 time points within treatment arms, as appropriate.
|
Baseline up to 60 months post-treatment initiation
|
Change in health-related quality of life within each arm
Time Frame: Baseline up to 60 months post-treatment initiation
|
Will be assessed by the Pediatric Quality of Life Inventory version 4.0.
One-sample confidence intervals will be used to estimate mean pairwise changes in scores between 2 time points within treatment arms, as appropriate.
|
Baseline up to 60 months post-treatment initiation
|
Change in health-related quality of life between the two treatment arms
Time Frame: Baseline up to 60 months post-treatment initiation
|
Will be assessed by the Pediatric Quality of Life Inventory version 4.0.
2-sample confidence interval approach will be used to estimate the difference in score changes between the two cohorts (WVSCI versus HDCSCR) in order to describe differential effects of the 2 treatment strategies.
|
Baseline up to 60 months post-treatment initiation
|
Radiation modality (proton versus photon)
Time Frame: Up to 10 years
|
Will summarize and compare functional outcomes, including cognitive, social and behavioral functioning, and auditory and neuro-endocrine function, in the context of the radiation therapy modality used.
Two sample t-tests for specified timepoints within each of the two treatment cohorts (WVSCI versus HDCSCR) will be used for comparisons.
|
Up to 10 years
|
Growth comparisons following radiation by radiation modality
Time Frame: Up to 10 years
|
Will compare early and late outcomes for proton and photon therapy with and without vertebral body sparing.
Height and weight of subjects who are < 13 years at the time of radiation therapy will be collected until subjects go off study or reach the age of 21, whichever is earlier.
Percentile values standardizing height and weight based on appropriate growth curves will be used to compare cohorts treated with proton- versus photon-based radiation therapy.
|
Up to 10 years
|
Complete blood count values following radiation by radiation modality
Time Frame: Up to 1 year post treatment initiation
|
Complete blood count values during radiation therapy will be used to compare these outcomes in the context of proton- versus photon-based radiation therapy.
|
Up to 1 year post treatment initiation
|
Local versus central review recommendations for second-look surgery
Time Frame: Up to 1 year post treatment initiation
|
Will summarize the local versus central review recommendations for second-look surgery and document any discrepancies.
|
Up to 1 year post treatment initiation
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shannon M MacDonald, Children's Oncology Group
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Pregnancy Complications
- Pregnancy Complications, Neoplastic
- Trophoblastic Neoplasms
- Mesonephroma
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Neoplasms
- Neoplasms, Germ Cell and Embryonal
- Teratoma
- Choriocarcinoma
- Endodermal Sinus Tumor
- Carcinoma, Embryonal
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Protective Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Dermatologic Agents
- Adjuvants, Immunologic
- Keratolytic Agents
- Carboplatin
- Etoposide
- Etoposide phosphate
- Ifosfamide
- Isophosphamide mustard
- Podophyllotoxin
- Lenograstim
- Thiotepa
- Mesna
Other Study ID Numbers
- ACNS2021 (Other Identifier: CTEP)
- U10CA180886 (U.S. NIH Grant/Contract)
- NCI-2020-13175 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Choriocarcinoma
-
Children's Oncology GroupNational Cancer Institute (NCI)RecruitingMalignant Germ Cell Tumor | Germ Cell Tumor | Childhood Extracranial Germ Cell Tumor | Extragonadal Embryonal Carcinoma | Malignant Ovarian Teratoma | Stage I Ovarian Choriocarcinoma | Stage I Ovarian Embryonal Carcinoma AJCC v6 and v7 | Stage I Ovarian Teratoma AJCC v6 and v7 | Stage I Ovarian Yolk... and other conditionsUnited States, Canada, Japan, Australia, Puerto Rico, New Zealand, Saudi Arabia, United Kingdom, India
-
Gynecologic Oncology GroupNational Cancer Institute (NCI); Eastern Cooperative Oncology GroupCompletedHydatidiform Mole | Good Prognosis Metastatic Gestational Trophoblastic Tumor | Non-Metastatic Gestational Trophoblastic Tumor | Uterine Corpus ChoriocarcinomaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedTesticular Yolk Sac Tumor | Recurrent Ovarian Germ Cell Tumor | Recurrent Childhood Malignant Germ Cell Tumor | Recurrent Malignant Testicular Germ Cell Tumor | Childhood Extracranial Germ Cell Tumor | Childhood Malignant Ovarian Germ Cell Tumor | Childhood Malignant Testicular Germ Cell Tumor | Ovarian... and other conditionsUnited States, Canada, Australia, Puerto Rico
-
Tracon Pharmaceuticals Inc.CompletedChoriocarcinomaUnited States
-
National Taiwan University HospitalNational Science Council, TaiwanUnknownTrophoblastic Neoplasms | ChoriocarcinomaTaiwan
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedTesticular Seminoma | Testicular Yolk Sac Tumor | Childhood Malignant Ovarian Germ Cell Tumor | Childhood Malignant Testicular Germ Cell Tumor | Ovarian Embryonal Carcinoma | Ovarian Yolk Sac Tumor | Testicular Embryonal Carcinoma | Ovarian Choriocarcinoma | Ovarian Mixed Germ Cell Tumor | Testicular Choriocarcinoma and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Central Nervous System Metastases | Childhood Central Nervous System Germ Cell Tumor | Childhood Central Nervous System Choriocarcinoma | Childhood Central Nervous System Germinoma | Childhood Central Nervous System Mixed Germ Cell Tumor | Childhood Central Nervous System Teratoma and other conditionsUnited States, Canada
-
Tracon Pharmaceuticals Inc.TerminatedGestational Trophoblastic Neoplasia | Choriocarcinoma | Placental Site Trophoblastic Tumor | Epithelioid Trophoblastic TumorUnited States
-
Eli Lilly and CompanyGynecologic Oncology GroupCompletedUterine Neoplasms | Trophoblastic Neoplasms | Hydatidiform Mole | ChoriocarcinomaUnited States
-
National Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Recurrent Childhood Brain Stem Glioma | Childhood Central Nervous System Germ Cell Tumor | Childhood Central Nervous System Choriocarcinoma | Childhood Central Nervous System Germinoma | Childhood Central Nervous System Mixed Germ Cell... and other conditionsUnited States
Clinical Trials on Carboplatin
-
Eisai Inc.CompletedCancerUnited States, Austria, India
-
Samyang Biopharmaceuticals CorporationCompleted
-
NHS Greater Glasgow and ClydeCompletedOvarian Cancer | Fallopian Tube Cancer | Primary Peritoneal Cavity CancerUnited Kingdom, Australia, New Zealand
-
Duke UniversityCompletedBrain and Central Nervous System TumorsUnited States, Canada
-
National Cancer Institute (NCI)CompletedBreast Cancer | Ovarian CancerUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteNational Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Eli Lilly and CompanyCompletedLung NeoplasmsUnited States
-
National Cancer Institute (NCI)Children's Oncology GroupCompletedBrain and Central Nervous System TumorsUnited States, Canada, Puerto Rico, Australia, Netherlands, New Zealand, Switzerland
-
All India Institute of Medical Sciences, New DelhiCouncil of Scientific and Industrial Research, IndiaUnknownIntraocular RetinoblastomaIndia
-
AkesoRecruitingAdvanced Squamous Non Small Cell Lung CancerChina