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
2018年1月17日 更新者：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.
研究概览
地位
完全的
详细说明
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.
研究类型
介入性
注册 (实际的)
104
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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-
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Quebec、加拿大、G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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British Columbia
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Vancouver、British Columbia、加拿大、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、加拿大、A1B 3V6
- Janeway Children's Health and Rehabilitation Centre
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Nova Scotia
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Halifax、Nova Scotia、加拿大、B3K 6R8
- IWK Health Centre
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Ontario
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Hamilton、Ontario、加拿大、L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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Toronto、Ontario、加拿大、M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal、Quebec、加拿大、H3H 1P3
- Montreal Children's Hospital at McGill University Health Center
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Montreal、Quebec、加拿大、H3T 1C5
- Hopital Sainte Justine
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Saskatchewan
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Saskatoon、Saskatchewan、加拿大、S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
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-
-
-
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Auckland、新西兰、1
- Starship Children's Health
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Christchurch、新西兰
- ChristChurch Hospital
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-
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Queensland
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Brisbane、Queensland、澳大利亚、4029
- Royal Children's Hospital
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Victoria
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Parkville、Victoria、澳大利亚、3052
- Royal Children's Hospital
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Western Australia
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Perth、Western Australia、澳大利亚、6001
- Princess Margaret Hospital for Children
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Bern、瑞士、3010
- Swiss Pediatric Oncology Group Bern
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Geneva、瑞士、1205
- Swiss Pediatric Oncology Group Geneva
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-
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Alabama
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Birmingham、Alabama、美国、35294
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
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Arizona
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Phoenix、Arizona、美国、85016-7710
- Phoenix Children's Hospital
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Arkansas
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Little Rock、Arkansas、美国、72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey、California、美国、90242-2814
- Southern California Permanente Medical Group
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Loma Linda、California、美国、92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach、California、美国、90801
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles、California、美国、90027
- Childrens Hospital Los Angeles
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Madera、California、美国、93638-8762
- Children's Hospital Central California
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Oakland、California、美国、94609
- Children's Hospital and Research Center Oakland
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Orange、California、美国、92868
- Children's Hospital of Orange County
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Sacramento、California、美国、95816
- Sutter Cancer center
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San Diego、California、美国、92123-4282
- Rady Children's Hospital - San Diego
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San Francisco、California、美国、94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Stanford、California、美国、94305-5824
- Stanford Cancer Center
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Connecticut
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Farmington、Connecticut、美国、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、美国、19803
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington、District of Columbia、美国、20010-2970
- Children's National Medical Center
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Florida
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Fort Myers、Florida、美国、33901
- Lee Cancer Care of Lee Memorial Health System
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Gainesville、Florida、美国、32610-0232
- University of Florida Shands Cancer Center
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Jacksonville、Florida、美国、32207
- Nemours Children's Clinic
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Miami、Florida、美国、33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami、Florida、美国、33155
- Miami Children's Hospital
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Orlando、Florida、美国、32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
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Pensacola、Florida、美国、32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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Saint Petersburg、Florida、美国、33701
- All Children's Hospital
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Tampa、Florida、美国、33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
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West Palm Beach、Florida、美国、33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta、Georgia、美国、30322
- Winship Cancer Institute of Emory University
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Augusta、Georgia、美国、30912-3730
- MBCCOP - Medical College of Georgia Cancer Center
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Illinois
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Chicago、Illinois、美国、60611
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Chicago、Illinois、美国、60637-1470
- University of Chicago Cancer Research Center
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Park Ridge、Illinois、美国、60068-1174
- Advocate Lutheran General Cancer Care Center
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Springfield、Illinois、美国、62794-9677
- Simmons Cooper Cancer Institute
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Indiana
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Indianapolis、Indiana、美国、46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis、Indiana、美国、46260
- St. Vincent Indianapolis Hospital
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Kansas
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Kansas City、Kansas、美国、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、美国、21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
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Massachusetts
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Boston、Massachusetts、美国、02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston、Massachusetts、美国、02111
- Floating Hospital for Children at Tufts - New England Medical Center
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Michigan
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Detroit、Michigan、美国、48201-1379
- Barbara Ann Karmanos Cancer Institute
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Grand Rapids、Michigan、美国、49503-2560
- Butterworth Hospital at Spectrum Health
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Grosse Pointe Woods、Michigan、美国、48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Lansing、Michigan、美国、48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Minnesota
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Minneapolis、Minnesota、美国、55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Minneapolis、Minnesota、美国、55455
- Masonic Cancer Center at University of Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson、Mississippi、美国、39216-4505
- University of Mississippi Cancer Clinic
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Missouri
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Kansas City、Missouri、美国、64108
- Children's Mercy Hospital
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Saint Louis、Missouri、美国、63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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New Jersey
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Hackensack、New Jersey、美国、07601
- Hackensack University Medical Center Cancer Center
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New Brunswick、New Jersey、美国、08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Newark、New Jersey、美国、07112
- Newark Beth Israel Medical Center
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Paterson、New Jersey、美国、07503
- St. Joseph's Hospital and Medical Center
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New Mexico
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Albuquerque、New Mexico、美国、87131-5636
- University of New Mexico Cancer Center
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New York
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Bronx、New York、美国、10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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New York、New York、美国、10016
- NYU Cancer Institute at New York University Medical Center
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New York、New York、美国、10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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Syracuse、New York、美国、13210
- SUNY Upstate Medical University Hospital
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Valhalla、New York、美国、10595
- New York Medical College
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North Carolina
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Charlotte、North Carolina、美国、28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Durham、North Carolina、美国、27710
- Duke Comprehensive Cancer Center
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Ohio
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Akron、Ohio、美国、44308-1062
- Akron Children's Hospital
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Cincinnati、Ohio、美国、45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland、Ohio、美国、44195
- Cleveland Clinic Taussig Cancer Center
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Columbus、Ohio、美国、43205-2696
- Nationwide Children's Hospital
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Dayton、Ohio、美国、45404-1815
- Children's Medical Center - Dayton
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Oklahoma
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Oklahoma City、Oklahoma、美国、73104
- Oklahoma University Cancer Institute
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Oregon
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Portland、Oregon、美国、97239-3098
- Oregon Health and Science University Cancer Institute
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Pennsylvania
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Hershey、Pennsylvania、美国、17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Philadelphia、Pennsylvania、美国、19134-1095
- St. Christopher's Hospital for Children
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Philadelphia、Pennsylvania、美国、19104-9786
- Children's Hospital of Philadelphia
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Pittsburgh、Pennsylvania、美国、15213
- Children's Hospital of Pittsburgh
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Rhode Island
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Providence、Rhode Island、美国、02903
- Rhode Island Hospital Comprehensive Cancer Center
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South Carolina
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Charleston、South Carolina、美国、29425
- Hollings Cancer Center at Medical University of South Carolina
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South Dakota
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Sioux Falls、South Dakota、美国、57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Tennessee
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Memphis、Tennessee、美国、38105
- St. Jude Children's Research Hospital
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Nashville、Tennessee、美国、37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Austin、Texas、美国、78723
- Dell Children's Medical Center of Central Texas
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Corpus Christi、Texas、美国、78411
- Driscoll Children's Hospital
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Dallas、Texas、美国、75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Fort Worth、Texas、美国、76104
- Cook Children's Medical Center - Fort Worth
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Lubbock、Texas、美国、79410
- Covenant Children's Hospital
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San Antonio、Texas、美国、78229-3993
- Methodist Children's Hospital of South Texas
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San Antonio、Texas、美国、78207
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City、Utah、美国、84113-1100
- Primary Children's Medical Center
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Virginia
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Norfolk、Virginia、美国、23507-1971
- Children's Hospital of The King's Daughters
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West Virginia
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Charleston、West Virginia、美国、25302
- West Virginia University Health Sciences Center - Charleston
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Wisconsin
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Green Bay、Wisconsin、美国、54307-3508
- St. Vincent Hospital Regional Cancer Center
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Marshfield、Wisconsin、美国、54449
- Marshfield Clinic - Marshfield Center
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Milwaukee、Wisconsin、美国、53226
- Midwest Children's Cancer Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
3年 至 24年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
鉴于IV
其他名称：
鉴于IV
其他名称：
鉴于IV
其他名称：
鉴于IV
其他名称：
craniospinal irradiation
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Response to Induction Chemotherapy
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The Probability of Event-free Survival (EFS)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Stewart Goldman, MD、Ann & Robert H Lurie Children's Hospital of Chicago
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2004年1月1日
初级完成 (实际的)
2009年2月1日
研究完成 (实际的)
2009年2月1日
研究注册日期
首次提交
2002年10月3日
首先提交符合 QC 标准的
2003年1月26日
首次发布 (估计)
2003年1月27日
研究记录更新
最后更新发布 (实际的)
2018年2月14日
上次提交的符合 QC 标准的更新
2018年1月17日
最后验证
2018年1月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- ACNS0122
- CDR0000257664 (其他标识符：Clinical Trials.gov)
- COG-ACNS0122 (其他标识符：Children's Oncology Group)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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-
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