Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors
17 janvier 2018 mis à jour par: Children's Oncology Group
A Phase II Study To Assess The Ability Of Neoadjuvant Chemotherapy Plus/Minus Second Look Surgery To Eliminate All Measurable Disease Prior To Radiotherapy For NGGCT
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it is no longer present by conventional imaging and tumor markers from serum and cerebrospinal fluid. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Combining different types of therapy may kill more tumor cells.
PURPOSE: This Phase II trial is studying how well neoadjuvant chemotherapy with or without surgery and with or without high dose chemotherapy and peripheral stem cell transplantation, can increase response rates prior to radiation therapy and increase progression free and overall surviving patients with newly diagnosed intracranial germ cell tumors.
Aperçu de l'étude
Statut
Complété
Intervention / Traitement
Description détaillée
OBJECTIVES:
- Determine the response rate of patients with non-germinomatous germ cell tumors treated with neoadjuvant chemotherapy.
- Determine the progression-free survival and overall survival of patients treated with neoadjuvant chemotherapy with or without second-look surgery followed by radiotherapy with or without autologous peripheral blood stem cell transplantation (PBSCT).
- Determine whether additional complete responses can be achieved after high-dose thiotepa and etoposide with PBSCT in patients with persistently positive markers, histological evidence of residual malignant elements, or unresectable residual tumors after initial neoadjuvant chemotherapy.
- Determine patterns of recurrence in patients treated with this regimen.
- Correlate tumor marker response with radiographic and clinical measures of response, as well as findings at second-look surgery in patients with radiological evidence of residual disease.
OUTLINE:
Induction chemotherapy:
- Courses 1, 3, and 5: Patients receive carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1-3. Beginning on day 4, patients receive filgrastim (G-CSF) IV or subcutaneously (SC) for 10 days or until blood counts recover. Courses are 3 weeks in duration.
- Courses 2, 4, and 6: Patients receive etoposide IV over 1 hour followed by ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive G-CSF IV or SC for 10 days or until blood counts recover. Courses are 3 weeks in duration.
Patients undergo re-evaluation. Patients with a complete response (CR) go directly to radiotherapy. Approximately 3 weeks after completion of induction chemotherapy, all patients with less than a CR are encouraged to undergo second-look surgery.
After second-look surgery, patients with a CR or a partial response (PR) go directly to radiotherapy. Patients with less than a PR undergo consolidation chemotherapy with peripheral blood stem cell rescue (PBSC) followed by radiotherapy.
- Consolidation chemotherapy: Patients undergo PBSC collection. Patients receive G-CSF SC until PBSC collection is complete. Patients then receive thiotepa IV over 3 hours followed by etoposide IV over 3 hours on days -5 to -3. PBSCs are reinfused on day 0. Beginning on day 1 and continuing until blood counts recover, patients receive G-CSF SC daily.
- Radiotherapy: All patients receive radiotherapy once daily 5 days a week for 5-6 weeks beginning after recovery from induction chemotherapy or second-look surgery or within 9 weeks after PBSC reinfusion.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 80-100 patients will be accrued for this study within 36-42 months.
Type d'étude
Interventionnel
Inscription (Réel)
104
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Queensland
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Brisbane, Queensland, Australie, 4029
- Royal Children's Hospital
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Victoria
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Parkville, Victoria, Australie, 3052
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Australie, 6001
- Princess Margaret Hospital for Children
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Quebec, Canada, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- Children's & Women's Hospital of British Columbia
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
- Janeway Children's Health and Rehabilitation Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 6R8
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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Toronto, Ontario, Canada, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canada, H3H 1P3
- Montreal Children's Hospital at McGill University Health Center
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Montreal, Quebec, Canada, H3T 1C5
- Hôpital Sainte Justine
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
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Auckland, Nouvelle-Zélande, 1
- Starship Children's Health
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Christchurch, Nouvelle-Zélande
- Christchurch Hospital
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Bern, Suisse, 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, Suisse, 1205
- Swiss Pediatric Oncology Group Geneva
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Alabama
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Birmingham, Alabama, États-Unis, 35294
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
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Arizona
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Phoenix, Arizona, États-Unis, 85016-7710
- Phoenix Children's Hospital
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Arkansas
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Little Rock, Arkansas, États-Unis, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, États-Unis, 90242-2814
- Southern California Permanente Medical Group
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Loma Linda, California, États-Unis, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, États-Unis, 90801
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles, California, États-Unis, 90027
- Childrens Hospital Los Angeles
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Madera, California, États-Unis, 93638-8762
- Children's Hospital Central California
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Oakland, California, États-Unis, 94609
- Children's Hospital and Research Center Oakland
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Orange, California, États-Unis, 92868
- Children's Hospital of Orange County
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Sacramento, California, États-Unis, 95816
- Sutter Cancer Center
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San Diego, California, États-Unis, 92123-4282
- Rady Children's Hospital - San Diego
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San Francisco, California, États-Unis, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Stanford, California, États-Unis, 94305-5824
- Stanford Cancer Center
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Connecticut
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Farmington, Connecticut, États-Unis, 06360-2875
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
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Delaware
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Wilmington, Delaware, États-Unis, 19803
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, États-Unis, 20010-2970
- Children's National Medical Center
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Florida
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Fort Myers, Florida, États-Unis, 33901
- Lee Cancer Care of Lee Memorial Health System
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Gainesville, Florida, États-Unis, 32610-0232
- University of Florida Shands Cancer Center
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Jacksonville, Florida, États-Unis, 32207
- Nemours Children's Clinic
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Miami, Florida, États-Unis, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami, Florida, États-Unis, 33155
- Miami Children's Hospital
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Orlando, Florida, États-Unis, 32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
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Pensacola, Florida, États-Unis, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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Saint Petersburg, Florida, États-Unis, 33701
- All Children's Hospital
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Tampa, Florida, États-Unis, 33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
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West Palm Beach, Florida, États-Unis, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, États-Unis, 30322
- Winship Cancer Institute of Emory University
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Augusta, Georgia, États-Unis, 30912-3730
- MBCCOP - Medical College of Georgia Cancer Center
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Illinois
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Chicago, Illinois, États-Unis, 60611
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Chicago, Illinois, États-Unis, 60637-1470
- University of Chicago Cancer Research Center
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Park Ridge, Illinois, États-Unis, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Springfield, Illinois, États-Unis, 62794-9677
- Simmons Cooper Cancer Institute
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Indiana
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Indianapolis, Indiana, États-Unis, 46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, États-Unis, 46260
- St. Vincent Indianapolis Hospital
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Kansas
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Kansas City, Kansas, États-Unis, 66160-7357
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
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Maryland
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Baltimore, Maryland, États-Unis, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Massachusetts
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Boston, Massachusetts, États-Unis, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, États-Unis, 02111
- Floating Hospital for Children at Tufts - New England Medical Center
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Michigan
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Detroit, Michigan, États-Unis, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Grand Rapids, Michigan, États-Unis, 49503-2560
- Butterworth Hospital at Spectrum Health
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Grosse Pointe Woods, Michigan, États-Unis, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Lansing, Michigan, États-Unis, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Minneapolis, Minnesota, États-Unis, 55455
- Masonic Cancer Center at University of Minnesota
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Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, États-Unis, 39216-4505
- University of Mississippi Cancer Clinic
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Missouri
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Kansas City, Missouri, États-Unis, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, États-Unis, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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New Jersey
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Hackensack, New Jersey, États-Unis, 07601
- Hackensack University Medical Center Cancer Center
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New Brunswick, New Jersey, États-Unis, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Newark, New Jersey, États-Unis, 07112
- Newark Beth Israel Medical Center
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Paterson, New Jersey, États-Unis, 07503
- St. Joseph's Hospital and Medical Center
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New Mexico
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Albuquerque, New Mexico, États-Unis, 87131-5636
- University of New Mexico Cancer Center
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New York
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Bronx, New York, États-Unis, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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New York, New York, États-Unis, 10016
- NYU Cancer Institute at New York University Medical Center
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New York, New York, États-Unis, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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Syracuse, New York, États-Unis, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, États-Unis, 10595
- New York Medical College
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North Carolina
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Charlotte, North Carolina, États-Unis, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Durham, North Carolina, États-Unis, 27710
- Duke Comprehensive Cancer Center
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Ohio
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Akron, Ohio, États-Unis, 44308-1062
- Akron Children's Hospital
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Cincinnati, Ohio, États-Unis, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, États-Unis, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, États-Unis, 43205-2696
- Nationwide Children's Hospital
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Dayton, Ohio, États-Unis, 45404-1815
- Children's Medical Center - Dayton
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73104
- Oklahoma University Cancer Institute
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Oregon
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Portland, Oregon, États-Unis, 97239-3098
- Oregon Health and Science University Cancer Institute
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Pennsylvania
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Hershey, Pennsylvania, États-Unis, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, États-Unis, 19134-1095
- St. Christopher's Hospital for Children
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Philadelphia, Pennsylvania, États-Unis, 19104-9786
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, États-Unis, 15213
- Children's Hospital of Pittsburgh
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Rhode Island
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Providence, Rhode Island, États-Unis, 02903
- Rhode Island Hospital Comprehensive Cancer Center
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South Carolina
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Charleston, South Carolina, États-Unis, 29425
- Hollings Cancer Center at Medical University of South Carolina
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South Dakota
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Sioux Falls, South Dakota, États-Unis, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Tennessee
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Memphis, Tennessee, États-Unis, 38105
- St. Jude Children's Research Hospital
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Nashville, Tennessee, États-Unis, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Austin, Texas, États-Unis, 78723
- Dell Children's Medical Center of Central Texas
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Corpus Christi, Texas, États-Unis, 78411
- Driscoll Children's Hospital
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Dallas, Texas, États-Unis, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Fort Worth, Texas, États-Unis, 76104
- Cook Children's Medical Center - Fort Worth
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Lubbock, Texas, États-Unis, 79410
- Covenant Children's Hospital
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San Antonio, Texas, États-Unis, 78229-3993
- Methodist Children's Hospital of South Texas
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San Antonio, Texas, États-Unis, 78207
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City, Utah, États-Unis, 84113-1100
- Primary Children's Medical Center
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Virginia
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Norfolk, Virginia, États-Unis, 23507-1971
- Children's Hospital of The King's Daughters
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West Virginia
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Charleston, West Virginia, États-Unis, 25302
- West Virginia University Health Sciences Center - Charleston
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Wisconsin
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Green Bay, Wisconsin, États-Unis, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Marshfield, Wisconsin, États-Unis, 54449
- Marshfield Clinic - Marshfield Center
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Milwaukee, Wisconsin, États-Unis, 53226
- Midwest Children's Cancer Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
3 ans à 24 ans (Enfant, Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
DISEASE CHARACTERISTICS:
One of the following diagnoses:
Histologically confirmed intracranial non-germinomatous germ cell tumor (NGGCT) of 1 of the following types:
- Endodermal sinus tumor (yolk sac tumor)
- Embryonal carcinoma
- Choriocarcinoma
- Immature teratoma and teratoma with malignant transformation
- Mixed germ cell tumor
- Histologically confirmed germinoma with elevation of serum/CSF beta human chorionic gonadotropin (HCG) levels greater than 50 mIU/mL or any serum/CSF alpha-fetoprotein (AFP) levels greater than 10 ng/ml or above institutional norm
- Histologically unconfirmed pineal and/or suprasellar tumors with serum/CSF beta HCG levels greater than 50 mIU/mL or AFP levels greater than 10 ng/ml or above institutional norm
- Patients with normal AFP and beta HCG < 50 mIU/mL without histologic diagnosis of a NGGCT or patients with pure germinoma without elevation of tumor marker are ineligible
- Initial diagnosis within the past 31 days
PATIENT CHARACTERISTICS:
Age
- 3 to 24 at diagnosis
Performance status
- No minimum performance level
Life expectancy
- At least 8 weeks
Hematopoietic
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3 (transfusion independent)
- Hemoglobin at least 10.0 g/dL (transfusion allowed)
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- ALT no greater than 2.5 times ULN
Renal
- Creatinine no greater than 1.5 times ULN OR
- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
Pulmonary
- No assisted ventilation
Other
- Seizure disorders allowed
- No patients in status or coma
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patient must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Prior corticosteroids allowed
- Concurrent corticosteroids allowed
- Concurrent endocrine replacement therapy allowed (e.g., L-thyroxine, testosterone, estrogen, desmopressin acetate)
- No concurrent growth hormone therapy
Radiotherapy
- Not specified
Surgery
- More than 1 prior surgery allowed
Other
- No other prior therapy for malignancy
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Radiation Therapy (CR from Induction)
Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6).
The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity.
Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours.
Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.
|
Étant donné IV
Autres noms:
Étant donné IV
Autres noms:
Étant donné IV
Autres noms:
Étant donné IV
Autres noms:
craniospinal irradiation
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Response to Induction Chemotherapy
Délai: 18 weeks
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A patient who achieves a complete or partial response, defined a reduction of at least 65% in tumor size after induction chemotherapy will be considered to have experienced response.
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18 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The Probability of Event-free Survival (EFS)
Délai: At 3 years from study entry
|
Event-free Survival was defined as time from study entry to death from any cause, disease progression or recurrence, or second malignant neoplasm.
Event-free survival was estimated by KM estimate.
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At 3 years from study entry
|
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Progression-free Survival (PFS)
Délai: At 3 years from study entry
|
Progression-free Survival was defined as time from study entry to disease progression or recurrence.
Deaths that are clearly unrelated to disease progression, and second neoplasms are censored in this analysis.
Progression -free survival was estimated by KM estimate.
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At 3 years from study entry
|
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Overall Survival (OS)
Délai: At 3 years from study entry
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Overall Survival was defined as time from study entry to death from any cause.
Overall survival was estimated by KM estimate.
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At 3 years from study entry
|
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Number of Patients Experiencing Toxic Death
Délai: During chemotherapy (up to 18 weeks)
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Toxic death, defined as death predominantly attributable to treatment-related causes.
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During chemotherapy (up to 18 weeks)
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Occurrence of Non-hematological Grade 4 Toxicity Occurrence of Nonhematological Grade 4 Toxicity
Délai: During chemotherapy(up to 18 weeks)
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The number of patients who experienced non-hematological grade 4 toxicities anytime during chemotherapy.
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During chemotherapy(up to 18 weeks)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Stewart Goldman, MD, Ann & Robert H Lurie Children's hospital of Chicago
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 janvier 2004
Achèvement primaire (Réel)
1 février 2009
Achèvement de l'étude (Réel)
1 février 2009
Dates d'inscription aux études
Première soumission
3 octobre 2002
Première soumission répondant aux critères de contrôle qualité
26 janvier 2003
Première publication (Estimation)
27 janvier 2003
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 février 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 janvier 2018
Dernière vérification
1 janvier 2018
Plus d'information
Termes liés à cette étude
Mots clés
- tumeur germinale du système nerveux central de l'enfant
- tératome infantile
- tumeur germinale maligne récurrente de l'enfant
- choriocarcinome du système nerveux central de l'enfant
- tumeur embryonnaire du système nerveux central de l'enfant
- germinome du système nerveux central de l'enfant
- tumeur germinale mixte du système nerveux central de l'enfant
- tératome du système nerveux central de l'enfant
- tumeur du sac vitellin du système nerveux central de l'enfant
- tumeur embryonnaire récurrente du système nerveux central de l'enfant
Termes MeSH pertinents supplémentaires
- Maladies du système nerveux
- Tumeurs par type histologique
- Tumeurs par site
- Tumeurs
- Tumeurs, cellules germinales et embryonnaires
- Tumeurs du système nerveux
- Tumeurs du système nerveux central
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Agents antinéoplasiques, alkylants
- Agents d'alkylation
- Agonistes myéloablatifs
- Agents antinéoplasiques phytogéniques
- Inhibiteurs de la topoisomérase II
- Inhibiteurs de la topoisomérase
- Carboplatine
- Étoposide
- Ifosfamide
- Moutarde isophosphamide
- Thiotépa
Autres numéros d'identification d'étude
- ACNS0122
- CDR0000257664 (Autre identifiant: Clinical Trials.gov)
- COG-ACNS0122 (Autre identifiant: Children's Oncology Group)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .