- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT00047320
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
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.
Обзор исследования
Статус
Условия
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 2
Контакты и местонахождение
Места учебы
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Queensland
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Brisbane, Queensland, Австралия, 4029
- Royal Children's Hospital
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Victoria
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Parkville, Victoria, Австралия, 3052
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Австралия, 6001
- Princess Margaret Hospital for Children
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Quebec, Канада, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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British Columbia
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Vancouver, British Columbia, Канада, 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, Канада, A1B 3V6
- Janeway Children's Health and Rehabilitation Centre
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Nova Scotia
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Halifax, Nova Scotia, Канада, B3K 6R8
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Канада, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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Toronto, Ontario, Канада, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Канада, H3H 1P3
- Montreal Children's Hospital at McGill University Health Center
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Montreal, Quebec, Канада, H3T 1C5
- Hôpital Sainte Justine
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Saskatchewan
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Saskatoon, Saskatchewan, Канада, S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
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Auckland, Новая Зеландия, 1
- Starship Children's Health
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Christchurch, Новая Зеландия
- Christchurch Hospital
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Alabama
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Birmingham, Alabama, Соединенные Штаты, 35294
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
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Arizona
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Phoenix, Arizona, Соединенные Штаты, 85016-7710
- Phoenix Children's Hospital
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Arkansas
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Little Rock, Arkansas, Соединенные Штаты, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, Соединенные Штаты, 90242-2814
- Southern California Permanente Medical Group
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Loma Linda, California, Соединенные Штаты, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, Соединенные Штаты, 90801
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles, California, Соединенные Штаты, 90027
- Childrens Hospital Los Angeles
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Madera, California, Соединенные Штаты, 93638-8762
- Children's Hospital Central California
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Oakland, California, Соединенные Штаты, 94609
- Children's Hospital and Research Center Oakland
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Orange, California, Соединенные Штаты, 92868
- Children's Hospital of Orange County
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Sacramento, California, Соединенные Штаты, 95816
- Sutter Cancer Center
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San Diego, California, Соединенные Штаты, 92123-4282
- Rady Children's Hospital - San Diego
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San Francisco, California, Соединенные Штаты, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Stanford, California, Соединенные Штаты, 94305-5824
- Stanford Cancer Center
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Connecticut
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Farmington, Connecticut, Соединенные Штаты, 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, Соединенные Штаты, 19803
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Соединенные Штаты, 20010-2970
- Children's National Medical Center
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Florida
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Fort Myers, Florida, Соединенные Штаты, 33901
- Lee Cancer Care of Lee Memorial Health System
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Gainesville, Florida, Соединенные Штаты, 32610-0232
- University of Florida Shands Cancer Center
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Jacksonville, Florida, Соединенные Штаты, 32207
- Nemours Children's Clinic
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Miami, Florida, Соединенные Штаты, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami, Florida, Соединенные Штаты, 33155
- Miami Children's Hospital
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Orlando, Florida, Соединенные Штаты, 32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
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Pensacola, Florida, Соединенные Штаты, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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Saint Petersburg, Florida, Соединенные Штаты, 33701
- All Children's Hospital
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Tampa, Florida, Соединенные Штаты, 33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
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West Palm Beach, Florida, Соединенные Штаты, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, Соединенные Штаты, 30322
- Winship Cancer Institute of Emory University
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Augusta, Georgia, Соединенные Штаты, 30912-3730
- MBCCOP - Medical College of Georgia Cancer Center
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Illinois
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Chicago, Illinois, Соединенные Штаты, 60611
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Chicago, Illinois, Соединенные Штаты, 60637-1470
- University of Chicago Cancer Research Center
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Park Ridge, Illinois, Соединенные Штаты, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Springfield, Illinois, Соединенные Штаты, 62794-9677
- Simmons Cooper Cancer Institute
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Indiana
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Indianapolis, Indiana, Соединенные Штаты, 46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, Соединенные Штаты, 46260
- St. Vincent Indianapolis Hospital
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Kansas
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Kansas City, Kansas, Соединенные Штаты, 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, Соединенные Штаты, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, Соединенные Штаты, 02111
- Floating Hospital for Children at Tufts - New England Medical Center
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Michigan
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Detroit, Michigan, Соединенные Штаты, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Grand Rapids, Michigan, Соединенные Штаты, 49503-2560
- Butterworth Hospital at Spectrum Health
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Grosse Pointe Woods, Michigan, Соединенные Штаты, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Lansing, Michigan, Соединенные Штаты, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Minnesota
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Minneapolis, Minnesota, Соединенные Штаты, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Minneapolis, Minnesota, Соединенные Штаты, 55455
- Masonic Cancer Center at University of Minnesota
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Rochester, Minnesota, Соединенные Штаты, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Соединенные Штаты, 39216-4505
- University of Mississippi Cancer Clinic
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Missouri
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Kansas City, Missouri, Соединенные Штаты, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, Соединенные Штаты, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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New Jersey
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Hackensack, New Jersey, Соединенные Штаты, 07601
- Hackensack University Medical Center Cancer Center
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New Brunswick, New Jersey, Соединенные Штаты, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Newark, New Jersey, Соединенные Штаты, 07112
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Соединенные Штаты, 07503
- St. Joseph's Hospital and Medical Center
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New Mexico
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Albuquerque, New Mexico, Соединенные Штаты, 87131-5636
- University of New Mexico Cancer Center
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New York
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Bronx, New York, Соединенные Штаты, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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New York, New York, Соединенные Штаты, 10016
- NYU Cancer Institute at New York University Medical Center
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New York, New York, Соединенные Штаты, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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Syracuse, New York, Соединенные Штаты, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, Соединенные Штаты, 10595
- New York Medical College
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North Carolina
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Charlotte, North Carolina, Соединенные Штаты, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Durham, North Carolina, Соединенные Штаты, 27710
- Duke Comprehensive Cancer Center
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Ohio
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Akron, Ohio, Соединенные Штаты, 44308-1062
- Akron Children's Hospital
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Cincinnati, Ohio, Соединенные Штаты, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, Соединенные Штаты, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, Соединенные Штаты, 43205-2696
- Nationwide Children's Hospital
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Dayton, Ohio, Соединенные Штаты, 45404-1815
- Children's Medical Center - Dayton
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Oklahoma
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Oklahoma City, Oklahoma, Соединенные Штаты, 73104
- Oklahoma University Cancer Institute
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Oregon
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Portland, Oregon, Соединенные Штаты, 97239-3098
- Oregon Health and Science University Cancer Institute
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Pennsylvania
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Hershey, Pennsylvania, Соединенные Штаты, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Соединенные Штаты, 19134-1095
- St. Christopher's Hospital for Children
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Philadelphia, Pennsylvania, Соединенные Штаты, 19104-9786
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Соединенные Штаты, 15213
- Children's Hospital of Pittsburgh
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Rhode Island
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Providence, Rhode Island, Соединенные Штаты, 02903
- Rhode Island Hospital Comprehensive Cancer Center
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South Carolina
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Charleston, South Carolina, Соединенные Штаты, 29425
- Hollings Cancer Center at Medical University of South Carolina
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South Dakota
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Sioux Falls, South Dakota, Соединенные Штаты, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Tennessee
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Memphis, Tennessee, Соединенные Штаты, 38105
- St. Jude Children's Research Hospital
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Nashville, Tennessee, Соединенные Штаты, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Austin, Texas, Соединенные Штаты, 78723
- Dell Children's Medical Center of Central Texas
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Corpus Christi, Texas, Соединенные Штаты, 78411
- Driscoll Children's Hospital
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Dallas, Texas, Соединенные Штаты, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Fort Worth, Texas, Соединенные Штаты, 76104
- Cook Children's Medical Center - Fort Worth
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Lubbock, Texas, Соединенные Штаты, 79410
- Covenant Children's Hospital
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San Antonio, Texas, Соединенные Штаты, 78229-3993
- Methodist Children's Hospital of South Texas
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San Antonio, Texas, Соединенные Штаты, 78207
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City, Utah, Соединенные Штаты, 84113-1100
- Primary Children's Medical Center
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Virginia
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Norfolk, Virginia, Соединенные Штаты, 23507-1971
- Children's Hospital of The King's Daughters
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West Virginia
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Charleston, West Virginia, Соединенные Штаты, 25302
- West Virginia University Health Sciences Center - Charleston
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Wisconsin
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Green Bay, Wisconsin, Соединенные Штаты, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Marshfield, Wisconsin, Соединенные Штаты, 54449
- Marshfield Clinic - Marshfield Center
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Milwaukee, Wisconsin, Соединенные Штаты, 53226
- Midwest Children's Cancer Center
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Bern, Швейцария, 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, Швейцария, 1205
- Swiss Pediatric Oncology Group Geneva
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
Учитывая IV
Другие имена:
Учитывая IV
Другие имена:
Учитывая IV
Другие имена:
Учитывая IV
Другие имена:
craniospinal irradiation
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Response to Induction Chemotherapy
Временное ограничение: 18 weeks
|
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.
|
18 weeks
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
The Probability of Event-free Survival (EFS)
Временное ограничение: 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.
|
At 3 years from study entry
|
|
Progression-free Survival (PFS)
Временное ограничение: 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.
|
At 3 years from study entry
|
|
Overall Survival (OS)
Временное ограничение: At 3 years from study entry
|
Overall Survival was defined as time from study entry to death from any cause.
Overall survival was estimated by KM estimate.
|
At 3 years from study entry
|
|
Number of Patients Experiencing Toxic Death
Временное ограничение: During chemotherapy (up to 18 weeks)
|
Toxic death, defined as death predominantly attributable to treatment-related causes.
|
During chemotherapy (up to 18 weeks)
|
|
Occurrence of Non-hematological Grade 4 Toxicity Occurrence of Nonhematological Grade 4 Toxicity
Временное ограничение: During chemotherapy(up to 18 weeks)
|
The number of patients who experienced non-hematological grade 4 toxicities anytime during chemotherapy.
|
During chemotherapy(up to 18 weeks)
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Учебный стул: Stewart Goldman, MD, Ann & Robert H Lurie Children's hospital of Chicago
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
- опухоль центральной нервной системы у детей
- детская тератома
- рецидивирующая злокачественная герминогенная опухоль у детей
- детская хориокарцинома центральной нервной системы
- Эмбриональная опухоль центральной нервной системы у детей
- детская герминома центральной нервной системы
- смешанная герминогенная опухоль центральной нервной системы у детей
- детская тератома центральной нервной системы
- детская опухоль желточного мешка центральной нервной системы
- рецидивирующая эмбриональная опухоль центральной нервной системы у детей
Дополнительные соответствующие термины MeSH
- Заболевания нервной системы
- Новообразования по гистологическому типу
- Новообразования по локализации
- Новообразования
- Новообразования, зародышевые клетки и эмбриональные
- Новообразования нервной системы
- Новообразования центральной нервной системы
- Физиологические эффекты лекарств
- Молекулярные механизмы фармакологического действия
- Ингибиторы ферментов
- Противоопухолевые агенты
- Иммунодепрессанты
- Иммунологические факторы
- Противоопухолевые агенты, алкилирующие
- Алкилирующие агенты
- Миелоаблативные агонисты
- Противоопухолевые агенты растительного происхождения
- Ингибиторы топоизомеразы II
- Ингибиторы топоизомеразы
- Карбоплатин
- Этопозид
- Ифосфамид
- Изофосфановая горчица
- Тиотепа
Другие идентификационные номера исследования
- ACNS0122
- CDR0000257664 (Другой идентификатор: Clinical Trials.gov)
- COG-ACNS0122 (Другой идентификатор: Children's Oncology Group)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .