Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
Childhood Extracranial Germ Cell Tumor, Extragonadal Embryonal Carcinoma, Germ Cell Tumor
About this trial
This is an interventional treatment trial for Childhood Extracranial Germ Cell Tumor
Eligibility Criteria
Inclusion Criteria:
- There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT [all sites])
- Standard risk 1: Patient must be < 11 years of age at enrollment
- Standard risk 2: Patients must be >= 11 and < 25 years of age at enrollment
- Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with metastatic germ cell tumor (stage II or higher); histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment except for those who were initially diagnosed with stage I non-seminoma malignant GCT and later recur during observation post surgery off study; for these patients, if elevated tumor markers rise to > 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart, a diagnostic biopsy is not required for enrollment
- Low risk stage I immature teratoma (IT); site: ovarian; stage: Children's Oncology Group (COG) stage I, Federation of Gynecology and Obstetrics (FIGO) stage IA and IB; grade: 2 or 3; histology: pure immature teratoma (may contain microscopic foci of yolk sac tumor), mixed immature and mature teratoma, (no pathological evidence of MGCT); tumor markers: alpha-FP =< 1,000 ng/mL, beta-HCG institutional normal; all ages
- Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA, IB and IS; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages
- Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular stage IA IB, and IS; histology: must contain at least one of the following: may contain immature/mature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages
- Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC, FIGO stage II-IV (International Germ Cell Consensus Classification [IGCCC] criteria DO NOT apply); histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) < 11
Standard risk 2 (SR2)
- Site: ovarian; stage: COG stage II and III, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) >= 11 and < 25
- Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; tumor markers: must be IGCCC good risk; post op: alpha-FP < 1,000 ng/mL, beta-HCG < 5,000 IU/mL and lactate dehydrogenase (LDH) < 3.0 x normal; age (years) >= 11 and < 25
- Site: extragonadal; stage: COG stage II; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) >= 11 and < 25
Notes:
- IGCCC criteria only apply to SR2 patients with a testicular primary tumor
- Use post-op tumor marker levels to determine IGCCC risk group
- Stage 1 seminoma patients are not eligible for the standard risk arms of the study
- For the low risk stage I non-seminoma MGCT and the standard risk arms, components of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can be mixed with other forms of GCT, such as seminoma or mature or immature teratoma; if yolk sac tumor is the only malignant component present, then it must be deemed by the pathologist to be greater than a "microscopic component" of yolk sac tumor
- Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
- Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients)
- Adequate renal function defined as:
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 (within 7 days prior to enrollment) OR
A serum creatinine based on age/gender as follows (within 7 days prior to enrollment): (mg/dL)
- 1 month to < 6 months male: 0.4 female: 0.4
- 6 months to < 1 year male: 0.5 female: 0.5
- 1 to < 2 years male: 0.6 female: 0.6
- 2 to < 6 years male: 0.8 female: 0.8
- 6 to < 10 years male: 1 female: 1
- 10 to < 13 years male: 1.2 female: 1.2
- 13 to < 16 years: male: 1.5 female: 1.4
- >= 16 years male: 1.7 female: 1.4
- Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
- Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age (for the purpose of this study, the ULN for SGPT is 45 U/L) (within 7 days prior to enrollment)
- Peripheral absolute neutrophil count (ANC) >= 1,000/mm^3 (within 7 days prior to enrollment) AND
- Platelet count >= 100,000/mm^3 (within 7 days prior to enrollment)
- Patients enrolling on the standard risk arms must be medically fit to receive protocol treatment and with no contraindications to protocol treatment
- Eligibility criteria to participate in the pilot study of the AYA-Hears instrument (patient reported outcomes [PROs] of ototoxicity) Note: participants in group 1 will not receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must be enrolled on the AGCT1531 SR2 arm in order to participate
- >= 11 and < 25 years old at enrollment
- Able to fluently speak and read English
- Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor
Followed for cancer or survivorship care at one of the following institutions:
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
- Dana Farber/Harvard Cancer Center
- Hospital for Sick Children
- Children's Hospital of Eastern Ontario
- Oregon Health and Science University
- Seattle Children's Hospital
- Yale University
Exclusion Criteria:
Patients with any diagnoses not listed including:
- Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection)
- Pure dysgerminoma
- Pure mature teratoma
- Pure immature teratoma COG stage I, grade I
- Pure immature teratoma COG stage I, grade 2,3 with alpha-fetoprotein (AFP) >= 1000 ng/mL
- Pure immature teratoma COG stage II - IV or FIGO stage IC to IV
- "Poor risk" GCT (age >= 11 years old and COG stage IV ovarian, COG stage III or IV EG, or IGCCC intermediate or poor risk testicular), or
- Primary central nervous system (CNS) germ cell tumor
- Germ cell tumor with somatic malignant transformation
- Spermatocytic seminoma
- Patients must have had no prior systemic therapy for the current cancer diagnosis
- Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain [stage IV disease] would be considered poor risk and therefore not eligible for this trial)
- Patients with significant, pre-existing co-morbid respiratory disease that contraindicate the use of bleomycin are ineligible for the standard risk arms of the trial
- Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])
- Lactating females who plan to breastfeed their infants; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])
- Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])
Sites / Locations
- Children's Hospital of AlabamaRecruiting
- USA Health Strada Patient Care Center
- Anchorage Associates in Radiation MedicineRecruiting
- Anchorage Radiation Therapy CenterRecruiting
- Alaska Breast Care and Surgery LLCRecruiting
- Alaska Oncology and Hematology LLCRecruiting
- Alaska Women's Cancer CareRecruiting
- Anchorage Oncology CentreRecruiting
- Katmai Oncology GroupRecruiting
- Providence Alaska Medical CenterRecruiting
- Kingman Regional Medical CenterRecruiting
- Banner Children's at DesertRecruiting
- Cancer Center at Saint Joseph's
- Phoenix Childrens HospitalRecruiting
- Banner University Medical Center - Tucson
- University of Arizona Cancer Center-North Campus
- CHI Saint Vincent Cancer Center Hot Springs
- Arkansas Children's HospitalRecruiting
- University of Arkansas for Medical Sciences
- Kaiser Permanente-AnaheimRecruiting
- Mission Hope Medical Oncology - Arroyo Grande
- PCR OncologyRecruiting
- Kaiser Permanente-BellflowerRecruiting
- Providence Saint Joseph Medical Center/Disney Family Cancer CenterRecruiting
- Mercy Cancer Center �� Carmichael
- Mercy San Juan Medical Center
- Kaiser Permanente Downey Medical CenterRecruiting
- City of Hope Comprehensive Cancer Center
- Mercy Cancer Center - Elk Grove
- Kaiser Permanente-FontanaRecruiting
- Loma Linda University Medical CenterRecruiting
- Miller Children's and Women's Hospital Long BeachRecruiting
- Children's Hospital Los AngelesRecruiting
- Kaiser Permanente Los Angeles Medical CenterRecruiting
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Cedars Sinai Medical CenterRecruiting
- Mattel Children's Hospital UCLARecruiting
- UCLA / Jonsson Comprehensive Cancer Center
- Valley Children's HospitalRecruiting
- Providence Queen of The ValleyRecruiting
- USC Norris Oncology/Hematology-Newport Beach
- UCSF Benioff Children's Hospital OaklandRecruiting
- Kaiser Permanente-OaklandRecruiting
- Children's Hospital of Orange CountyRecruiting
- Lucile Packard Children's Hospital Stanford UniversityRecruiting
- Stanford Cancer Institute Palo Alto
- Mercy Cancer Center - Rocklin
- Kaiser Permanente-Roseville
- Mercy Cancer Center - Sacramento
- Sutter Medical Center Sacramento
- University of California Davis Comprehensive Cancer CenterRecruiting
- Kaiser Permanente-San Diego MissionRecruiting
- Rady Children's Hospital - San DiegoRecruiting
- Naval Medical Center -San DiegoRecruiting
- UCSF Medical Center-Mission BayRecruiting
- Pacific Central Coast Health Center-San Luis Obispo
- Kaiser Permanente Medical Center - Santa Clara
- Mission Hope Medical Oncology - Santa Maria
- Providence Medical Foundation - Santa RosaRecruiting
- Providence Santa Rosa Memorial HospitalRecruiting
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Woodland Memorial Hospital
- Children's Hospital ColoradoRecruiting
- UCHealth University of Colorado Hospital
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- UCHealth Memorial Hospital Central
- Memorial Hospital North
- Saint Francis Cancer Center
- Porter Adventist Hospital
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical CenterRecruiting
- Mercy Medical Center
- Southwest Oncology PC
- Poudre Valley Hospital
- Cancer Care and Hematology-Fort Collins
- Mountain Blue Cancer Care Center
- UCHealth Greeley Hospital
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Littleton Adventist Hospital
- UCHealth Lone Tree Health Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- Medical Center of the Rockies
- Parker Adventist Hospital
- Rocky Mountain Cancer Centers-Parker
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers - Pueblo
- Rocky Mountain Cancer Centers-Thornton
- Connecticut Children's Medical CenterRecruiting
- Yale UniversityRecruiting
- Alfred I duPont Hospital for ChildrenRecruiting
- Kaiser Permanente-Capitol Hill Medical Center
- MedStar Georgetown University HospitalRecruiting
- Children's National Medical CenterRecruiting
- Broward Health Medical CenterRecruiting
- Golisano Children's Hospital of Southwest FloridaRecruiting
- University of Florida Health Science Center - GainesvilleRecruiting
- Memorial Regional Hospital/Joe DiMaggio Children's HospitalRecruiting
- Nemours Children's Clinic-JacksonvilleRecruiting
- University of Miami Miller School of Medicine-Sylvester Cancer CenterRecruiting
- Nicklaus Children's HospitalRecruiting
- Miami Cancer InstituteRecruiting
- AdventHealth OrlandoRecruiting
- Arnold Palmer Hospital for ChildrenRecruiting
- Nemours Children's HospitalRecruiting
- Nemours Children's Clinic - Pensacola
- Sacred Heart HospitalRecruiting
- Johns Hopkins All Children's HospitalRecruiting
- Tampa General HospitalRecruiting
- Saint Joseph's Hospital/Children's Hospital-TampaRecruiting
- Saint Mary's HospitalRecruiting
- Children's Healthcare of Atlanta - EglestonRecruiting
- Augusta University Medical CenterRecruiting
- Medical Center of Central GeorgiaRecruiting
- Memorial Health University Medical CenterRecruiting
- Straub Clinic and HospitalRecruiting
- Kaiser Permanente Moanalua Medical Center
- Kapiolani Medical Center for Women and ChildrenRecruiting
- Tripler Army Medical CenterRecruiting
- Saint Luke's Cancer Institute - BoiseRecruiting
- Saint Luke's Cancer Institute - FruitlandRecruiting
- Saint Luke's Cancer Institute - MeridianRecruiting
- Saint Luke's Cancer Institute - NampaRecruiting
- Saint Luke's Cancer Institute - Twin FallsRecruiting
- Rush - Copley Medical Center
- Illinois CancerCare-BloomingtonRecruiting
- Illinois CancerCare-CantonRecruiting
- Memorial Hospital of CarbondaleRecruiting
- SIH Cancer InstituteRecruiting
- Illinois CancerCare-CarthageRecruiting
- Centralia Oncology ClinicRecruiting
- Lurie Children's Hospital-ChicagoRecruiting
- John H Stroger Jr Hospital of Cook County
- Rush University Medical Center
- University of IllinoisRecruiting
- University of Chicago Comprehensive Cancer CenterRecruiting
- Carle at The Riverfront
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial HospitalRecruiting
- Illinois CancerCare-DixonRecruiting
- Carle Physician Group-Effingham
- Crossroads Cancer CenterRecruiting
- Illinois CancerCare-EurekaRecruiting
- NorthShore University HealthSystem-Evanston HospitalRecruiting
- Illinois CancerCare-GalesburgRecruiting
- Western Illinois Cancer Treatment CenterRecruiting
- NorthShore University HealthSystem-Glenbrook HospitalRecruiting
- NorthShore University HealthSystem-Highland Park HospitalRecruiting
- Illinois CancerCare-Kewanee ClinicRecruiting
- Illinois CancerCare-MacombRecruiting
- Carle Physician Group-Mattoon/Charleston
- Loyola University Medical Center
- Cancer Care Center of O'FallonRecruiting
- Advocate Children's Hospital-Oak LawnRecruiting
- Illinois CancerCare-Ottawa ClinicRecruiting
- Advocate Children's Hospital-Park RidgeRecruiting
- Illinois CancerCare-PekinRecruiting
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment CenterRecruiting
- Illinois CancerCare-PeoriaRecruiting
- OSF Saint Francis Radiation Oncology at Peoria Cancer CenterRecruiting
- Methodist Medical Center of IllinoisRecruiting
- OSF Saint Francis Medical CenterRecruiting
- Saint Jude Midwest AffiliateRecruiting
- Illinois CancerCare-PeruRecruiting
- Valley Radiation OncologyRecruiting
- Illinois CancerCare-PrincetonRecruiting
- North Shore Medical Center
- Saint John's HospitalRecruiting
- Southern Illinois University School of MedicineRecruiting
- Springfield ClinicRecruiting
- Memorial Medical CenterRecruiting
- Southwest Illinois Health Services LLP
- Carle Cancer Center
- The Carle Foundation Hospital
- Illinois CancerCare - WashingtonRecruiting
- Rush-Copley Healthcare Center
- IU Health North Hospital
- Deaconess Clinic Downtown
- Indiana University/Melvin and Bren Simon Cancer Center
- Riley Hospital for ChildrenRecruiting
- Ascension Saint Vincent Indianapolis HospitalRecruiting
- Chancellor Center for Oncology
- Memorial Hospital of South Bend
- Medical Oncology and Hematology Associates-West Des MoinesRecruiting
- Mercy Cancer Center-West LakesRecruiting
- Alegent Health Mercy Hospital
- Greater Regional Medical CenterRecruiting
- Blank Children's HospitalRecruiting
- Iowa Methodist Medical CenterRecruiting
- Mercy Medical Center - Des MoinesRecruiting
- Mission Cancer and Blood - LaurelRecruiting
- Iowa Lutheran Hospital
- University of Iowa/Holden Comprehensive Cancer CenterRecruiting
- Mercy Medical Center-West LakesRecruiting
- Flaget Memorial Hospital
- Commonwealth Cancer Center-Corbin
- Saint Joseph Hospital
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital East
- University of Kentucky/Markey Cancer CenterRecruiting
- Saint Joseph London
- Jewish Hospital
- Norton Children's HospitalRecruiting
- Saints Mary and Elizabeth Hospital
- UofL Health Medical Center Northeast
- Saint Joseph Mount Sterling
- Jewish Hospital Medical Center South
- Children's Hospital New OrleansRecruiting
- Ochsner Medical Center Jefferson
- Eastern Maine Medical Center
- Lafayette Family Cancer Center-EMMC
- Maine Medical Center-Bramhall CampusRecruiting
- Maine Children's Cancer ProgramRecruiting
- Maine Medical Center- Scarborough CampusRecruiting
- University of Maryland/Greenebaum Cancer CenterRecruiting
- Sinai Hospital of BaltimoreRecruiting
- Johns Hopkins University/Sidney Kimmel Cancer CenterRecruiting
- Walter Reed National Military Medical CenterRecruiting
- Tufts Children's Hospital
- Tufts Medical CenterRecruiting
- Massachusetts General Hospital Cancer CenterRecruiting
- Dana-Farber Cancer InstituteRecruiting
- Baystate Medical CenterRecruiting
- UMass Memorial Medical Center - University CampusRecruiting
- C S Mott Children's HospitalRecruiting
- Bronson Battle CreekRecruiting
- Children's Hospital of MichiganRecruiting
- Ascension Saint John Hospital
- Michigan State University Clinical CenterRecruiting
- Green Bay Oncology - Escanaba
- Hurley Medical Center
- Helen DeVos Children's Hospital at Spectrum HealthRecruiting
- Spectrum Health at Butterworth CampusRecruiting
- Trinity Health Grand Rapids HospitalRecruiting
- Bronson Methodist HospitalRecruiting
- West Michigan Cancer CenterRecruiting
- Borgess Medical CenterRecruiting
- Trinity Health Muskegon HospitalRecruiting
- Lakeland Hospital NilesRecruiting
- Lake Huron Medical Center
- Spectrum Health Reed City HospitalRecruiting
- Beaumont Children's Hospital-Royal OakRecruiting
- Lakeland Medical Center Saint JosephRecruiting
- Marie Yeager Cancer CenterRecruiting
- Munson Medical CenterRecruiting
- University of Michigan Health - WestRecruiting
- Essentia Health Cancer Center
- Children's Hospitals and Clinics of Minnesota - MinneapolisRecruiting
- University of Minnesota/Masonic Cancer CenterRecruiting
- Mayo Clinic in RochesterRecruiting
- University of Mississippi Medical CenterRecruiting
- Parkland Health Center-Bonne Terre
- Saint Francis Medical CenterRecruiting
- Southeast Cancer CenterRecruiting
- Parkland Health Center - FarmingtonRecruiting
- Capital Region Southwest CampusRecruiting
- Children's Mercy Hospitals and ClinicsRecruiting
- Washington University School of MedicineRecruiting
- Missouri Baptist Medical CenterRecruiting
- Mercy Hospital Saint LouisRecruiting
- Sainte Genevieve County Memorial HospitalRecruiting
- Missouri Baptist Sullivan HospitalRecruiting
- Missouri Baptist Outpatient Center-Sunset HillsRecruiting
- Saint Patrick Hospital - Community HospitalRecruiting
- CHI Health Saint Francis
- Heartland Hematology and Oncology
- CHI Health Good Samaritan
- Saint Elizabeth Regional Medical Center
- Children's Hospital and Medical Center of OmahaRecruiting
- Alegent Health Immanuel Medical Center
- Hematology and Oncology Consultants PC
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- University of Nebraska Medical CenterRecruiting
- Midlands Community Hospital
- Carson Tahoe Regional Medical CenterRecruiting
- Cancer and Blood Specialists-Henderson
- Comprehensive Cancer Centers of Nevada - HendersonRecruiting
- Comprehensive Cancer Centers of Nevada-Horizon RidgeRecruiting
- Las Vegas Cancer Center-Henderson
- OptumCare Cancer Care at Seven HillsRecruiting
- Comprehensive Cancer Centers of Nevada-Southeast HendersonRecruiting
- Las Vegas Urology - Green ValleyRecruiting
- Las Vegas Urology - PebbleRecruiting
- Urology Specialists of Nevada - Green ValleyRecruiting
- Las Vegas Urology - PecosRecruiting
- Desert West Surgery
- OptumCare Cancer Care at CharlestonRecruiting
- University Medical Center of Southern NevadaRecruiting
- Hope Cancer Care of NevadaRecruiting
- Cancer and Blood Specialists-Shadow
- Radiation Oncology Centers of Nevada CentralRecruiting
- Urology Specialists of Nevada - CentralRecruiting
- Women's Cancer Center of Nevada
- Sunrise Hospital and Medical CenterRecruiting
- Las Vegas Urology - SunsetRecruiting
- Urology Specialists of Nevada - SouthwestRecruiting
- Radiation Oncology Centers of Nevada SoutheastRecruiting
- Cancer Therapy and Integrative Medicine
- Ann M Wierman MD LTDRecruiting
- Cancer and Blood Specialists-Tenaya
- Comprehensive Cancer Centers of Nevada - NorthwestRecruiting
- Las Vegas Urology - Cathedral RockRecruiting
- Las Vegas Urology - Smoke RanchRecruiting
- OptumCare Cancer Care at MountainViewRecruiting
- Urology Specialists of Nevada - NorthwestRecruiting
- Alliance for Childhood Diseases/Cure 4 the Kids FoundationRecruiting
- Comprehensive Cancer Centers of Nevada - Town CenterRecruiting
- Comprehensive Cancer Centers of Nevada-SummerlinRecruiting
- Summerlin Hospital Medical CenterRecruiting
- Las Vegas Cancer Center-Medical Center
- Comprehensive Cancer Centers of NevadaRecruiting
- OptumCare Cancer Care at Fort ApacheRecruiting
- Comprehensive Cancer Centers of Nevada - Central ValleyRecruiting
- University Cancer Center
- Hope Cancer Care of Nevada-PahrumpRecruiting
- Renown Regional Medical CenterRecruiting
- Saint Mary's Regional Medical CenterRecruiting
- Radiation Oncology AssociatesRecruiting
- Cancer Care Specialists - Reno
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
- Hackensack University Medical CenterRecruiting
- Morristown Medical CenterRecruiting
- Saint Peter's University HospitalRecruiting
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University HospitalRecruiting
- Newark Beth Israel Medical CenterRecruiting
- Saint Joseph's Regional Medical CenterRecruiting
- University of New Mexico Cancer CenterRecruiting
- Albany Medical CenterRecruiting
- Montefiore Medical Center - Moses CampusRecruiting
- Maimonides Medical CenterRecruiting
- Roswell Park Cancer InstituteRecruiting
- Glens Falls Hospital
- NYU Winthrop HospitalRecruiting
- The Steven and Alexandra Cohen Children's Medical Center of New YorkRecruiting
- Laura and Isaac Perlmutter Cancer Center at NYU LangoneRecruiting
- Mount Sinai HospitalRecruiting
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- University of RochesterRecruiting
- Stony Brook University Medical CenterRecruiting
- State University of New York Upstate Medical UniversityRecruiting
- New York Medical CollegeRecruiting
- Westchester Medical CenterRecruiting
- Mission HospitalRecruiting
- UNC Lineberger Comprehensive Cancer CenterRecruiting
- Carolinas Medical Center/Levine Cancer InstituteRecruiting
- Novant Health Presbyterian Medical CenterRecruiting
- Oncology Specialists of Charlotte
- Southern Oncology Specialists-Charlotte
- Southeastern Medical Oncology Center-ClintonRecruiting
- Duke University Medical CenterRecruiting
- Southeastern Medical Oncology Center-GoldsboroRecruiting
- Wayne Memorial Hospital
- Novant Health Cancer Institute - Huntersville
- Southern Oncology Specialists-Huntersville
- Southeastern Medical Oncology Center-JacksonvilleRecruiting
- Matthews Radiation Oncology Center
- Novant Health Cancer Institute - Matthews
- Novant Health Cancer Institute - Mooresville
- Novant Health Cancer Institute - Rowan
- Rowan Regional Medical Center
- Wake Forest University Health SciencesRecruiting
- Sanford Broadway Medical CenterRecruiting
- Children's Hospital Medical Center of AkronRecruiting
- Strecker Cancer Center-BelpreRecruiting
- Adena Regional Medical CenterRecruiting
- Good Samaritan Hospital - Cincinnati
- Cincinnati Children's Hospital Medical CenterRecruiting
- Bethesda North Hospital
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Case Western Reserve UniversityRecruiting
- Rainbow Babies and Childrens HospitalRecruiting
- Cleveland Clinic FoundationRecruiting
- Nationwide Children's HospitalRecruiting
- Mount Carmel East HospitalRecruiting
- Columbus Oncology and Hematology Associates IncRecruiting
- Riverside Methodist HospitalRecruiting
- Grant Medical CenterRecruiting
- The Mark H Zangmeister CenterRecruiting
- Mount Carmel Health Center WestRecruiting
- Doctors HospitalRecruiting
- Dayton Children's HospitalRecruiting
- Delaware Health Center-Grady Cancer CenterRecruiting
- Grady Memorial HospitalRecruiting
- Columbus Oncology and Hematology Associates
- Dublin Methodist HospitalRecruiting
- Mount Carmel Grove City HospitalRecruiting
- Saint Rita's Medical CenterRecruiting
- OhioHealth Mansfield HospitalRecruiting
- Marietta Memorial HospitalRecruiting
- OhioHealth Marion General HospitalRecruiting
- Knox Community HospitalRecruiting
- Licking Memorial HospitalRecruiting
- Mercy Health Perrysburg Cancer CenterRecruiting
- Southern Ohio Medical CenterRecruiting
- ProMedica Flower HospitalRecruiting
- ProMedica Toledo Hospital/Russell J Ebeid Children's HospitalRecruiting
- Saint Vincent Mercy Medical CenterRecruiting
- Mercy Health - Saint Anne HospitalRecruiting
- Saint Ann's HospitalRecruiting
- Genesis Healthcare System Cancer Care CenterRecruiting
- Cancer Centers of Southwest Oklahoma Research
- University of Oklahoma Health Sciences CenterRecruiting
- Saint Charles Health SystemRecruiting
- Clackamas Radiation Oncology CenterRecruiting
- Providence Cancer Institute Clackamas ClinicRecruiting
- Bay Area HospitalRecruiting
- Rogue Valley Medical Center
- Providence Newberg Medical CenterRecruiting
- Providence Willamette Falls Medical CenterRecruiting
- Providence Portland Medical CenterRecruiting
- Providence Saint Vincent Medical CenterRecruiting
- Legacy Emanuel Children's HospitalRecruiting
- Oregon Health and Science UniversityRecruiting
- Jefferson Abington Hospital
- Lehigh Valley Hospital-Cedar CrestRecruiting
- Lehigh Valley Hospital - Muhlenberg
- Geisinger Medical CenterRecruiting
- Penn State Children's HospitalRecruiting
- Children's Hospital of PhiladelphiaRecruiting
- University of Pennsylvania/Abramson Cancer CenterRecruiting
- Saint Christopher's Hospital for ChildrenRecruiting
- UPMC-Magee Womens HospitalRecruiting
- Children's Hospital of Pittsburgh of UPMCRecruiting
- University of Pittsburgh Cancer Institute (UPCI)Recruiting
- UPMC-Passavant HospitalRecruiting
- Asplundh Cancer Pavilion
- Rhode Island HospitalRecruiting
- Prisma Health Cancer Institute - SpartanburgRecruiting
- Medical University of South CarolinaRecruiting
- Prisma Health Richland HospitalRecruiting
- Gibbs Cancer Center-GaffneyRecruiting
- Saint Francis HospitalRecruiting
- BI-LO Charities Children's Cancer CenterRecruiting
- Prisma Health Cancer Institute - ButternutRecruiting
- Prisma Health Cancer Institute - FarisRecruiting
- Prisma Health Greenville Memorial HospitalRecruiting
- Saint Francis Cancer CenterRecruiting
- Prisma Health Cancer Institute - EastsideRecruiting
- Prisma Health Cancer Institute - GreerRecruiting
- Gibbs Cancer Center-PelhamRecruiting
- Prisma Health Cancer Institute - SenecaRecruiting
- North Grove Medical ParkRecruiting
- Spartanburg Medical CenterRecruiting
- Spartanburg Medical Center - Mary Black CampusRecruiting
- MGC Hematology Oncology-UnionRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- T C Thompson Children's HospitalRecruiting
- Memorial Hospital
- Pulmonary Medicine Center of Chattanooga-Hixson
- East Tennessee Childrens HospitalRecruiting
- Saint Jude Children's Research HospitalRecruiting
- The Children's Hospital at TriStar CentennialRecruiting
- Vanderbilt University/Ingram Cancer CenterRecruiting
- Memorial GYN Plus
- The Don and Sybil Harrington Cancer Center
- Dell Children's Medical Center of Central TexasRecruiting
- Saint Joseph Regional Cancer Center
- Driscoll Children's HospitalRecruiting
- Medical City Dallas HospitalRecruiting
- Parkland Memorial HospitalRecruiting
- UT Southwestern/Simmons Cancer Center-DallasRecruiting
- El Paso Children's HospitalRecruiting
- Texas Tech University Health Sciences Center-El Paso
- Cook Children's Medical CenterRecruiting
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterRecruiting
- M D Anderson Cancer CenterRecruiting
- Covenant Children's HospitalRecruiting
- UMC Cancer Center / UMC Health SystemRecruiting
- Texas Tech University Health Sciences Center-Lubbock
- Children's Hospital of San AntonioRecruiting
- Methodist Children's Hospital of South TexasRecruiting
- University HospitalRecruiting
- University of Texas Health Science Center at San AntonioRecruiting
- Scott and White Memorial HospitalRecruiting
- Primary Children's HospitalRecruiting
- Central Vermont Medical Center/National Life Cancer Treatment
- University of Vermont Medical Center
- University of Vermont and State Agricultural CollegeRecruiting
- University of Virginia Cancer CenterRecruiting
- Children's Hospital of The King's DaughtersRecruiting
- Naval Medical Center - PortsmouthRecruiting
- Virginia Commonwealth University/Massey Cancer CenterRecruiting
- Providence Regional Cancer System-AberdeenRecruiting
- Overlake Medical Center
- PeaceHealth Saint Joseph Medical CenterRecruiting
- Harrison HealthPartners Hematology and Oncology-BremertonRecruiting
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-CentraliaRecruiting
- Swedish Cancer Institute-EdmondsRecruiting
- Saint Elizabeth Hospital
- Providence Regional Cancer PartnershipRecruiting
- Saint Francis Hospital
- Swedish Cancer Institute-IssaquahRecruiting
- Kadlec Clinic Hematology and OncologyRecruiting
- Providence Regional Cancer System-LaceyRecruiting
- Saint Clare Hospital
- PeaceHealth Saint John Medical CenterRecruiting
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- Pacific Gynecology Specialists
- Seattle Children's HospitalRecruiting
- Swedish Medical Center-Ballard CampusRecruiting
- Kaiser Permanente Washington
- Swedish Medical Center-Cherry HillRecruiting
- Swedish Medical Center-First HillRecruiting
- Providence Regional Cancer System-SheltonRecruiting
- MultiCare Deaconess Cancer and Blood Specialty Center - Valley
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
- Providence Sacred Heart Medical Center and Children's HospitalRecruiting
- MultiCare Deaconess Cancer and Blood Specialty Center - North
- Franciscan Research Center-Northwest Medical Plaza
- Mary Bridge Children's Hospital and Health CenterRecruiting
- Northwest Medical Specialties PLLC
- Madigan Army Medical CenterRecruiting
- PeaceHealth Southwest Medical CenterRecruiting
- Providence Saint Mary Regional Cancer CenterRecruiting
- North Star Lodge Cancer Center at Yakima Valley Memorial HospitalRecruiting
- Providence Regional Cancer System-YelmRecruiting
- United Hospital Center
- West Virginia University Charleston DivisionRecruiting
- WVUH-Berkely Medical Center
- West Virginia University HealthcareRecruiting
- Camden Clark Medical Center
- Green Bay Oncology at Saint Vincent HospitalRecruiting
- Saint Vincent Hospital Cancer Center Green BayRecruiting
- Saint Vincent Hospital Cancer Center at Saint Mary'sRecruiting
- UW Cancer Center Johnson CreekRecruiting
- University of Wisconsin Carbone Cancer CenterRecruiting
- Holy Family Memorial Hospital
- Saint Vincent Hospital Cancer Center at Marinette
- Marshfield Medical Center-MarshfieldRecruiting
- Children's Hospital of WisconsinRecruiting
- Saint Vincent Hospital Cancer Center at Oconto FallsRecruiting
- HSHS Saint Nicholas HospitalRecruiting
- Saint Vincent Hospital Cancer Center at Sturgeon BayRecruiting
- John Hunter Children's HospitalRecruiting
- Sydney Children's HospitalRecruiting
- The Children's Hospital at WestmeadRecruiting
- Queensland Children's HospitalRecruiting
- Monash Medical Center-Clayton CampusRecruiting
- Royal Children's HospitalRecruiting
- Princess Margaret Hospital for Children
- Perth Children's Hospital
- Alberta Children's HospitalRecruiting
- University of Alberta HospitalRecruiting
- British Columbia Children's HospitalRecruiting
- CancerCare ManitobaRecruiting
- Janeway Child Health CentreRecruiting
- IWK Health CentreRecruiting
- McMaster Children's Hospital at Hamilton Health SciencesRecruiting
- Kingston Health Sciences CentreRecruiting
- Children's HospitalRecruiting
- Children's Hospital of Eastern OntarioRecruiting
- Odette Cancer Centre- Sunnybrook Health Sciences CentreRecruiting
- Hospital for Sick ChildrenRecruiting
- University Health Network-Princess Margaret HospitalRecruiting
- The Montreal Children's Hospital of the MUHCRecruiting
- Centre Hospitalier Universitaire Sainte-JustineRecruiting
- Centre Hospitalier Universitaire de QuebecRecruiting
- Tohoku University School of MedicineRecruiting
- Niigata Cancer CentreRecruiting
- Kyushu UniveristyRecruiting
- Hyogo Prefectural Kobe Children's HospitalRecruiting
- University of Tsukuba HospitalRecruiting
- Kanagawa Children's Medical CenterRecruiting
- Saitama Children's Medical CenterRecruiting
- Keio UniversityRecruiting
- Hiroshima University HospitalRecruiting
- Kyoto Perfectural University of MedicineRecruiting
- Hyogo College of MedicineRecruiting
- Osaka City General HospitalRecruiting
- Saitama Medical University International Medical CenterRecruiting
- Kokuritsu Seiiku Medical Research Center HospitalRecruiting
- Starship Children's HospitalRecruiting
- Christchurch HospitalRecruiting
- HIMA San Pablo Oncologic HospitalRecruiting
- San Jorge Children's Hospital
- King Faisal Specialist Hospital and Research CentreRecruiting
- Addenbrookes Hospital-Medical SchoolRecruiting
- Saint Bartholomew's HospitalRecruiting
- University College London Hospitals NHS Trust - Foley StreetRecruiting
- Saint James's University HospitalRecruiting
- Royal Hospital for Children and Young PeopleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Arm I (bleomycin, carboplatin, etoposide)
Arm II (bleomycin, etoposide, cisplatin)
Arm III (bleomycin, etoposide, carboplatin)
Arm IV (bleomycin, etoposide, cisplatin)
Low-Risk (observation)
Patients receive bleomycin IV over 10 minutes and carboplatin IV over 1 hour on day 1. Patients also receive etoposide IV over 1-2 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
Patients receive bleomycin IV over 10 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
Patients with low-risk stage I grade 2, 3 ovarian immature teratoma or stage I non-seminoma or seminoma MGCTs undergo observation and can transfer to standard risk arm when eligibility criteria are met. Patients with stage I seminoma testicular MGCT undergo observation, and those with residual/recurrent disease are treated at the discretion of their physician. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial.