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
2018년 1월 17일 업데이트: 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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
104
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Auckland, 뉴질랜드, 1
- Starship Children's Health
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Christchurch, 뉴질랜드
- Christchurch Hospital
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Alabama
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Birmingham, Alabama, 미국, 35294
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
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Arizona
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Phoenix, Arizona, 미국, 85016-7710
- Phoenix Children's Hospital
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Arkansas
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Little Rock, Arkansas, 미국, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, 미국, 90242-2814
- Southern California Permanente Medical Group
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Loma Linda, California, 미국, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, 미국, 90801
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles, California, 미국, 90027
- Childrens Hospital Los Angeles
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Madera, California, 미국, 93638-8762
- Children's Hospital Central California
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Oakland, California, 미국, 94609
- Children's Hospital and Research Center Oakland
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Orange, California, 미국, 92868
- Children's Hospital of Orange County
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Sacramento, California, 미국, 95816
- Sutter Cancer center
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San Diego, California, 미국, 92123-4282
- Rady Children's Hospital - San Diego
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San Francisco, California, 미국, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Stanford, California, 미국, 94305-5824
- Stanford Cancer Center
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Connecticut
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Farmington, Connecticut, 미국, 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, 미국, 19803
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, 미국, 20010-2970
- Children's National Medical Center
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Florida
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Fort Myers, Florida, 미국, 33901
- Lee Cancer Care of Lee Memorial Health System
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Gainesville, Florida, 미국, 32610-0232
- University of Florida Shands Cancer Center
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Jacksonville, Florida, 미국, 32207
- Nemours Children's Clinic
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Miami, Florida, 미국, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami, Florida, 미국, 33155
- Miami Children's Hospital
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Orlando, Florida, 미국, 32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
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Pensacola, Florida, 미국, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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Saint Petersburg, Florida, 미국, 33701
- All Children's Hospital
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Tampa, Florida, 미국, 33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
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West Palm Beach, Florida, 미국, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, 미국, 30322
- Winship Cancer Institute of Emory University
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Augusta, Georgia, 미국, 30912-3730
- MBCCOP - Medical College of Georgia Cancer Center
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Illinois
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Chicago, Illinois, 미국, 60611
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Chicago, Illinois, 미국, 60637-1470
- University of Chicago Cancer Research Center
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Park Ridge, Illinois, 미국, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Springfield, Illinois, 미국, 62794-9677
- Simmons Cooper Cancer Institute
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Indiana
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Indianapolis, Indiana, 미국, 46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, 미국, 46260
- St. Vincent Indianapolis Hospital
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Kansas
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Kansas City, Kansas, 미국, 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, 미국, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, 미국, 02111
- Floating Hospital for Children at Tufts - New England Medical Center
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Michigan
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Detroit, Michigan, 미국, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Grand Rapids, Michigan, 미국, 49503-2560
- Butterworth Hospital at Spectrum Health
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Grosse Pointe Woods, Michigan, 미국, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Lansing, Michigan, 미국, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Minnesota
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Minneapolis, Minnesota, 미국, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Minneapolis, Minnesota, 미국, 55455
- Masonic Cancer Center at University of Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, 미국, 39216-4505
- University of Mississippi Cancer Clinic
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Missouri
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Kansas City, Missouri, 미국, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, 미국, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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New Jersey
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Hackensack, New Jersey, 미국, 07601
- Hackensack University Medical Center Cancer Center
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New Brunswick, New Jersey, 미국, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Newark, New Jersey, 미국, 07112
- Newark Beth Israel Medical Center
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Paterson, New Jersey, 미국, 07503
- St. Joseph's Hospital and Medical Center
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New Mexico
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Albuquerque, New Mexico, 미국, 87131-5636
- University of New Mexico Cancer Center
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New York
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Bronx, New York, 미국, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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New York, New York, 미국, 10016
- NYU Cancer Institute at New York University Medical Center
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New York, New York, 미국, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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Syracuse, New York, 미국, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, 미국, 10595
- New York Medical College
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North Carolina
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Charlotte, North Carolina, 미국, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Durham, North Carolina, 미국, 27710
- Duke Comprehensive Cancer Center
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Ohio
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Akron, Ohio, 미국, 44308-1062
- Akron Children's Hospital
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Cincinnati, Ohio, 미국, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, 미국, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, 미국, 43205-2696
- Nationwide Children's Hospital
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Dayton, Ohio, 미국, 45404-1815
- Children's Medical Center - Dayton
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73104
- Oklahoma University Cancer Institute
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Oregon
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Portland, Oregon, 미국, 97239-3098
- Oregon Health and Science University Cancer Institute
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Pennsylvania
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Hershey, Pennsylvania, 미국, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, 미국, 19134-1095
- St. Christopher's Hospital for Children
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Philadelphia, Pennsylvania, 미국, 19104-9786
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, 미국, 15213
- Children's Hospital of Pittsburgh
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Rhode Island
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Providence, Rhode Island, 미국, 02903
- Rhode Island Hospital Comprehensive Cancer Center
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South Carolina
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Charleston, South Carolina, 미국, 29425
- Hollings Cancer Center at Medical University of South Carolina
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South Dakota
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Sioux Falls, South Dakota, 미국, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Tennessee
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Memphis, Tennessee, 미국, 38105
- St. Jude Children's Research Hospital
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Nashville, Tennessee, 미국, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Austin, Texas, 미국, 78723
- Dell Children's Medical Center of Central Texas
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Corpus Christi, Texas, 미국, 78411
- Driscoll Children's Hospital
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Dallas, Texas, 미국, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Fort Worth, Texas, 미국, 76104
- Cook Children's Medical Center - Fort Worth
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Lubbock, Texas, 미국, 79410
- Covenant Children's Hospital
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San Antonio, Texas, 미국, 78229-3993
- Methodist Children's Hospital of South Texas
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San Antonio, Texas, 미국, 78207
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City, Utah, 미국, 84113-1100
- Primary Children's Medical Center
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Virginia
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Norfolk, Virginia, 미국, 23507-1971
- Children's Hospital of The King's Daughters
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West Virginia
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Charleston, West Virginia, 미국, 25302
- West Virginia University Health Sciences Center - Charleston
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Wisconsin
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Green Bay, Wisconsin, 미국, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Marshfield, Wisconsin, 미국, 54449
- Marshfield Clinic - Marshfield Center
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Milwaukee, Wisconsin, 미국, 53226
- Midwest Children's Cancer Center
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Bern, 스위스, 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, 스위스, 1205
- Swiss Pediatric Oncology Group Geneva
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Quebec, 캐나다, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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British Columbia
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Vancouver, British Columbia, 캐나다, 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, 캐나다, A1B 3V6
- Janeway Children's Health and Rehabilitation Centre
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Nova Scotia
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Halifax, Nova Scotia, 캐나다, B3K 6R8
- IWK Health Centre
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Ontario
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Hamilton, Ontario, 캐나다, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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Toronto, Ontario, 캐나다, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, 캐나다, H3H 1P3
- Montreal Children's Hospital at McGill University Health Center
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Montreal, Quebec, 캐나다, H3T 1C5
- Hopital Sainte Justine
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Saskatchewan
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Saskatoon, Saskatchewan, 캐나다, S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
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Queensland
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Brisbane, Queensland, 호주, 4029
- Royal Children's Hospital
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Victoria
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Parkville, Victoria, 호주, 3052
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, 호주, 6001
- Princess Margaret Hospital for Children
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
3년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
주어진 IV
다른 이름들:
주어진 IV
다른 이름들:
주어진 IV
다른 이름들:
주어진 IV
다른 이름들:
craniospinal irradiation
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Response to Induction Chemotherapy
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The Probability of Event-free Survival (EFS)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Stewart Goldman, MD, Ann & Robert H Lurie Children's Hospital of Chicago
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2004년 1월 1일
기본 완료 (실제)
2009년 2월 1일
연구 완료 (실제)
2009년 2월 1일
연구 등록 날짜
최초 제출
2002년 10월 3일
QC 기준을 충족하는 최초 제출
2003년 1월 26일
처음 게시됨 (추정)
2003년 1월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 2월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 1월 17일
마지막으로 확인됨
2018년 1월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- ACNS0122
- CDR0000257664 (기타 식별자: Clinical Trials.gov)
- COG-ACNS0122 (기타 식별자: Children's Oncology Group)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
뇌종양에 대한 임상 시험
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University of Dublin, Trinity College알려지지 않은Brain Health 은퇴 엘리트 선수
보조 요법에 대한 임상 시험
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Alpha Tau Medical LTD.European Organisation for Research and Treatment of Cancer - EORTC아직 모집하지 않음
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Alpha Tau Medical LTD.모병
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Medical University of South CarolinaNational Institute on Deafness and Other Communication Disorders (NIDCD)모집하지 않고 적극적으로
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University of Alabama at Birmingham완전한
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Abbott Medical Devices완전한