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.
調査の概要
状態
完了
詳細な説明
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.
研究の種類
介入
入学 (実際)
104
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Alabama
-
Birmingham、Alabama、アメリカ、35294
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
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Arizona
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Phoenix、Arizona、アメリカ、85016-7710
- Phoenix Children's Hospital
-
-
Arkansas
-
Little Rock、Arkansas、アメリカ、72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey、California、アメリカ、90242-2814
- Southern California Permanente Medical Group
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Loma Linda、California、アメリカ、92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach、California、アメリカ、90801
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles、California、アメリカ、90027
- Childrens Hospital Los Angeles
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Madera、California、アメリカ、93638-8762
- Children's Hospital Central California
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Oakland、California、アメリカ、94609
- Children's Hospital and Research Center Oakland
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Orange、California、アメリカ、92868
- Children's Hospital of Orange County
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Sacramento、California、アメリカ、95816
- Sutter Cancer Center
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San Diego、California、アメリカ、92123-4282
- Rady Children's Hospital - San Diego
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San Francisco、California、アメリカ、94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Stanford、California、アメリカ、94305-5824
- Stanford Cancer Center
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Connecticut
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Farmington、Connecticut、アメリカ、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、アメリカ、19803
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington、District of Columbia、アメリカ、20010-2970
- Children's National Medical Center
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Florida
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Fort Myers、Florida、アメリカ、33901
- Lee Cancer Care of Lee Memorial Health System
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Gainesville、Florida、アメリカ、32610-0232
- University of Florida Shands Cancer Center
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Jacksonville、Florida、アメリカ、32207
- Nemours Children's Clinic
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Miami、Florida、アメリカ、33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami、Florida、アメリカ、33155
- Miami Children's Hospital
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Orlando、Florida、アメリカ、32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
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Pensacola、Florida、アメリカ、32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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Saint Petersburg、Florida、アメリカ、33701
- All Children's Hospital
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Tampa、Florida、アメリカ、33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
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West Palm Beach、Florida、アメリカ、33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta、Georgia、アメリカ、30322
- Winship Cancer Institute of Emory University
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Augusta、Georgia、アメリカ、30912-3730
- MBCCOP - Medical College of Georgia Cancer Center
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Illinois
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Chicago、Illinois、アメリカ、60611
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Chicago、Illinois、アメリカ、60637-1470
- University of Chicago Cancer Research Center
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Park Ridge、Illinois、アメリカ、60068-1174
- Advocate Lutheran General Cancer Care Center
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Springfield、Illinois、アメリカ、62794-9677
- Simmons Cooper Cancer Institute
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Indiana
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Indianapolis、Indiana、アメリカ、46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis、Indiana、アメリカ、46260
- St. Vincent Indianapolis Hospital
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Kansas
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Kansas City、Kansas、アメリカ、66160-7357
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
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Maryland
-
Baltimore、Maryland、アメリカ、21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Massachusetts
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Boston、Massachusetts、アメリカ、02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston、Massachusetts、アメリカ、02111
- Floating Hospital for Children at Tufts - New England Medical Center
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Michigan
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Detroit、Michigan、アメリカ、48201-1379
- Barbara Ann Karmanos Cancer Institute
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Grand Rapids、Michigan、アメリカ、49503-2560
- Butterworth Hospital at Spectrum Health
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Grosse Pointe Woods、Michigan、アメリカ、48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Lansing、Michigan、アメリカ、48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Minnesota
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Minneapolis、Minnesota、アメリカ、55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Minneapolis、Minnesota、アメリカ、55455
- Masonic Cancer Center at University of Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic Cancer Center
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Mississippi
-
Jackson、Mississippi、アメリカ、39216-4505
- University of Mississippi Cancer Clinic
-
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Missouri
-
Kansas City、Missouri、アメリカ、64108
- Children's Mercy Hospital
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Saint Louis、Missouri、アメリカ、63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
-
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New Jersey
-
Hackensack、New Jersey、アメリカ、07601
- Hackensack University Medical Center Cancer Center
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New Brunswick、New Jersey、アメリカ、08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Newark、New Jersey、アメリカ、07112
- Newark Beth Israel Medical Center
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Paterson、New Jersey、アメリカ、07503
- St. Joseph's Hospital and Medical Center
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New Mexico
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Albuquerque、New Mexico、アメリカ、87131-5636
- University of New Mexico Cancer Center
-
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New York
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Bronx、New York、アメリカ、10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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New York、New York、アメリカ、10016
- NYU Cancer Institute at New York University Medical Center
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New York、New York、アメリカ、10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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Syracuse、New York、アメリカ、13210
- SUNY Upstate Medical University Hospital
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Valhalla、New York、アメリカ、10595
- New York Medical College
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North Carolina
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Charlotte、North Carolina、アメリカ、28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Durham、North Carolina、アメリカ、27710
- Duke Comprehensive Cancer Center
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Ohio
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Akron、Ohio、アメリカ、44308-1062
- Akron Children's Hospital
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Cincinnati、Ohio、アメリカ、45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic Taussig Cancer Center
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Columbus、Ohio、アメリカ、43205-2696
- Nationwide Children's Hospital
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Dayton、Ohio、アメリカ、45404-1815
- Children's Medical Center - Dayton
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73104
- Oklahoma University Cancer Institute
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Oregon
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Portland、Oregon、アメリカ、97239-3098
- Oregon Health and Science University Cancer Institute
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Pennsylvania
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Hershey、Pennsylvania、アメリカ、17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Philadelphia、Pennsylvania、アメリカ、19134-1095
- St. Christopher's Hospital for Children
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Philadelphia、Pennsylvania、アメリカ、19104-9786
- Children's Hospital of Philadelphia
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Pittsburgh、Pennsylvania、アメリカ、15213
- Children's Hospital of Pittsburgh
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Rhode Island
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Providence、Rhode Island、アメリカ、02903
- Rhode Island Hospital Comprehensive Cancer Center
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South Carolina
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Charleston、South Carolina、アメリカ、29425
- Hollings Cancer Center at Medical University of South Carolina
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South Dakota
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Sioux Falls、South Dakota、アメリカ、57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Tennessee
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Memphis、Tennessee、アメリカ、38105
- St. Jude Children's Research Hospital
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Nashville、Tennessee、アメリカ、37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Austin、Texas、アメリカ、78723
- Dell Children's Medical Center of Central Texas
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Corpus Christi、Texas、アメリカ、78411
- Driscoll Children's Hospital
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Dallas、Texas、アメリカ、75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Fort Worth、Texas、アメリカ、76104
- Cook Children's Medical Center - Fort Worth
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Lubbock、Texas、アメリカ、79410
- Covenant Children's Hospital
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San Antonio、Texas、アメリカ、78229-3993
- Methodist Children's Hospital of South Texas
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San Antonio、Texas、アメリカ、78207
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City、Utah、アメリカ、84113-1100
- Primary Children's Medical Center
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Virginia
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Norfolk、Virginia、アメリカ、23507-1971
- Children's Hospital of The King's Daughters
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West Virginia
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Charleston、West Virginia、アメリカ、25302
- West Virginia University Health Sciences Center - Charleston
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Wisconsin
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Green Bay、Wisconsin、アメリカ、54307-3508
- St. Vincent Hospital Regional Cancer Center
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Marshfield、Wisconsin、アメリカ、54449
- Marshfield Clinic - Marshfield Center
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Milwaukee、Wisconsin、アメリカ、53226
- Midwest Children's Cancer Center
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Queensland
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Brisbane、Queensland、オーストラリア、4029
- Royal Children's Hospital
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Victoria
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Parkville、Victoria、オーストラリア、3052
- Royal Children's Hospital
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Western Australia
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Perth、Western Australia、オーストラリア、6001
- Princess Margaret Hospital for Children
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Quebec、カナダ、G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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British Columbia
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Vancouver、British Columbia、カナダ、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、カナダ、A1B 3V6
- Janeway Children's Health and Rehabilitation Centre
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Nova Scotia
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Halifax、Nova Scotia、カナダ、B3K 6R8
- IWK Health Centre
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Ontario
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Hamilton、Ontario、カナダ、L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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Toronto、Ontario、カナダ、M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal、Quebec、カナダ、H3H 1P3
- Montreal Children's Hospital at McGill University Health Center
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Montreal、Quebec、カナダ、H3T 1C5
- Hôpital Sainte Justine
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Saskatchewan
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Saskatoon、Saskatchewan、カナダ、S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
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-
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Bern、スイス、3010
- Swiss Pediatric Oncology Group Bern
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Geneva、スイス、1205
- Swiss Pediatric Oncology Group Geneva
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-
-
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Auckland、ニュージーランド、1
- Starship Children's Health
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Christchurch、ニュージーランド
- Christchurch Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
3年～24年 (子、大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
与えられた IV
他の名前：
与えられた IV
他の名前：
与えられた IV
他の名前：
与えられた IV
他の名前：
craniospinal irradiation
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Response to Induction Chemotherapy
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The Probability of Event-free Survival (EFS)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディチェア：Stewart Goldman, MD、Ann & Robert H Lurie Children's Hospital of Chicago
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2004年1月1日
一次修了 (実際)
2009年2月1日
研究の完了 (実際)
2009年2月1日
試験登録日
最初に提出
2002年10月3日
QC基準を満たした最初の提出物
2003年1月26日
最初の投稿 (見積もり)
2003年1月27日
学習記録の更新
投稿された最後の更新 (実際)
2018年2月14日
QC基準を満たした最後の更新が送信されました
2018年1月17日
最終確認日
2018年1月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- ACNS0122
- CDR0000257664 (その他の識別子：Clinical Trials.gov)
- COG-ACNS0122 (その他の識別子：Children's Oncology Group)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。