- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Queensland
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Brisbane, Queensland, Australien, 4029
- Royal Children's Hospital
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Victoria
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Parkville, Victoria, Australien, 3052
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Australien, 6001
- Princess Margaret Hospital for Children
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Quebec, Kanada, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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British Columbia
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Vancouver, British Columbia, Kanada, 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, Kanada, A1B 3V6
- Janeway Children's Health and Rehabilitation Centre
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3K 6R8
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Kanada, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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Toronto, Ontario, Kanada, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Kanada, H3H 1P3
- Montreal Children's Hospital at McGill University Health Center
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Montreal, Quebec, Kanada, H3T 1C5
- Hopital Sainte Justine
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Saskatchewan
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Saskatoon, Saskatchewan, Kanada, S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
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Auckland, Neuseeland, 1
- Starship Children's Health
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Christchurch, Neuseeland
- Christchurch Hospital
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Bern, Schweiz, 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, Schweiz, 1205
- Swiss Pediatric Oncology Group Geneva
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35294
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
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Arizona
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Phoenix, Arizona, Vereinigte Staaten, 85016-7710
- Phoenix Children's Hospital
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Arkansas
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Little Rock, Arkansas, Vereinigte Staaten, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, Vereinigte Staaten, 90242-2814
- Southern California Permanente Medical Group
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Loma Linda, California, Vereinigte Staaten, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, Vereinigte Staaten, 90801
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles, California, Vereinigte Staaten, 90027
- Childrens Hospital Los Angeles
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Madera, California, Vereinigte Staaten, 93638-8762
- Children's Hospital Central California
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Oakland, California, Vereinigte Staaten, 94609
- Children's Hospital and Research Center Oakland
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Orange, California, Vereinigte Staaten, 92868
- Children's Hospital of Orange County
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Sacramento, California, Vereinigte Staaten, 95816
- Sutter Cancer Center
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San Diego, California, Vereinigte Staaten, 92123-4282
- Rady Children's Hospital - San Diego
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San Francisco, California, Vereinigte Staaten, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Stanford, California, Vereinigte Staaten, 94305-5824
- Stanford Cancer Center
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Connecticut
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Farmington, Connecticut, Vereinigte Staaten, 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, Vereinigte Staaten, 19803
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Vereinigte Staaten, 20010-2970
- Children's National Medical Center
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Florida
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Fort Myers, Florida, Vereinigte Staaten, 33901
- Lee Cancer Care of Lee Memorial Health System
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Gainesville, Florida, Vereinigte Staaten, 32610-0232
- University of Florida Shands Cancer Center
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Jacksonville, Florida, Vereinigte Staaten, 32207
- Nemours Children's Clinic
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Miami, Florida, Vereinigte Staaten, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami, Florida, Vereinigte Staaten, 33155
- Miami Children's Hospital
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Orlando, Florida, Vereinigte Staaten, 32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
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Pensacola, Florida, Vereinigte Staaten, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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Saint Petersburg, Florida, Vereinigte Staaten, 33701
- All Children's Hospital
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Tampa, Florida, Vereinigte Staaten, 33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
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West Palm Beach, Florida, Vereinigte Staaten, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30322
- Winship Cancer Institute of Emory University
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Augusta, Georgia, Vereinigte Staaten, 30912-3730
- MBCCOP - Medical College of Georgia Cancer Center
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60611
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Chicago, Illinois, Vereinigte Staaten, 60637-1470
- University of Chicago Cancer Research Center
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Park Ridge, Illinois, Vereinigte Staaten, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Springfield, Illinois, Vereinigte Staaten, 62794-9677
- Simmons Cooper Cancer Institute
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Indiana
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Indianapolis, Indiana, Vereinigte Staaten, 46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, Vereinigte Staaten, 46260
- St. Vincent Indianapolis Hospital
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Kansas
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Kansas City, Kansas, Vereinigte Staaten, 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, Vereinigte Staaten, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, Vereinigte Staaten, 02111
- Floating Hospital for Children at Tufts - New England Medical Center
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Michigan
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Detroit, Michigan, Vereinigte Staaten, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Grand Rapids, Michigan, Vereinigte Staaten, 49503-2560
- Butterworth Hospital at Spectrum Health
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Grosse Pointe Woods, Michigan, Vereinigte Staaten, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Lansing, Michigan, Vereinigte Staaten, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Minnesota
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Minneapolis, Minnesota, Vereinigte Staaten, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Minneapolis, Minnesota, Vereinigte Staaten, 55455
- Masonic Cancer Center at University of Minnesota
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Rochester, Minnesota, Vereinigte Staaten, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Vereinigte Staaten, 39216-4505
- University of Mississippi Cancer Clinic
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Missouri
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Kansas City, Missouri, Vereinigte Staaten, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, Vereinigte Staaten, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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New Jersey
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Hackensack, New Jersey, Vereinigte Staaten, 07601
- Hackensack University Medical Center Cancer Center
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New Brunswick, New Jersey, Vereinigte Staaten, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Newark, New Jersey, Vereinigte Staaten, 07112
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Vereinigte Staaten, 07503
- St. Joseph's Hospital and Medical Center
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New Mexico
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Albuquerque, New Mexico, Vereinigte Staaten, 87131-5636
- University of New Mexico Cancer Center
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New York
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Bronx, New York, Vereinigte Staaten, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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New York, New York, Vereinigte Staaten, 10016
- NYU Cancer Institute at New York University Medical Center
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New York, New York, Vereinigte Staaten, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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Syracuse, New York, Vereinigte Staaten, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, Vereinigte Staaten, 10595
- New York Medical College
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North Carolina
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Charlotte, North Carolina, Vereinigte Staaten, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Durham, North Carolina, Vereinigte Staaten, 27710
- Duke Comprehensive Cancer Center
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Ohio
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Akron, Ohio, Vereinigte Staaten, 44308-1062
- Akron Children's Hospital
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Cincinnati, Ohio, Vereinigte Staaten, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, Vereinigte Staaten, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, Vereinigte Staaten, 43205-2696
- Nationwide Children's Hospital
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Dayton, Ohio, Vereinigte Staaten, 45404-1815
- Children's Medical Center - Dayton
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Oklahoma
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Oklahoma City, Oklahoma, Vereinigte Staaten, 73104
- Oklahoma University Cancer Institute
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Oregon
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Portland, Oregon, Vereinigte Staaten, 97239-3098
- Oregon Health and Science University Cancer Institute
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Pennsylvania
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Hershey, Pennsylvania, Vereinigte Staaten, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19134-1095
- St. Christopher's Hospital for Children
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19104-9786
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Vereinigte Staaten, 15213
- Children's Hospital of Pittsburgh
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Rhode Island
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Providence, Rhode Island, Vereinigte Staaten, 02903
- Rhode Island Hospital Comprehensive Cancer Center
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South Carolina
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Charleston, South Carolina, Vereinigte Staaten, 29425
- Hollings Cancer Center at Medical University of South Carolina
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South Dakota
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Sioux Falls, South Dakota, Vereinigte Staaten, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Tennessee
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Memphis, Tennessee, Vereinigte Staaten, 38105
- St. Jude Children's Research Hospital
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Nashville, Tennessee, Vereinigte Staaten, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Austin, Texas, Vereinigte Staaten, 78723
- Dell Children's Medical Center of Central Texas
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Corpus Christi, Texas, Vereinigte Staaten, 78411
- Driscoll Children's Hospital
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Dallas, Texas, Vereinigte Staaten, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Fort Worth, Texas, Vereinigte Staaten, 76104
- Cook Children's Medical Center - Fort Worth
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Lubbock, Texas, Vereinigte Staaten, 79410
- Covenant Children's Hospital
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San Antonio, Texas, Vereinigte Staaten, 78229-3993
- Methodist Children's Hospital of South Texas
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San Antonio, Texas, Vereinigte Staaten, 78207
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City, Utah, Vereinigte Staaten, 84113-1100
- Primary Children's Medical Center
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Virginia
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Norfolk, Virginia, Vereinigte Staaten, 23507-1971
- Children's Hospital of The King's Daughters
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West Virginia
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Charleston, West Virginia, Vereinigte Staaten, 25302
- West Virginia University Health Sciences Center - Charleston
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Wisconsin
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Green Bay, Wisconsin, Vereinigte Staaten, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Marshfield, Wisconsin, Vereinigte Staaten, 54449
- Marshfield Clinic - Marshfield Center
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Milwaukee, Wisconsin, Vereinigte Staaten, 53226
- Midwest Children's Cancer Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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.
|
Gegeben IV
Andere Namen:
Gegeben IV
Andere Namen:
Gegeben IV
Andere Namen:
Gegeben IV
Andere Namen:
craniospinal irradiation
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Response to Induction Chemotherapy
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
The Probability of Event-free Survival (EFS)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Studienstuhl: Stewart Goldman, MD, Ann & Robert H Lurie Children's Hospital of Chicago
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
- Keimzelltumor des zentralen Nervensystems im Kindesalter
- Teratom im Kindesalter
- rezidivierender bösartiger Keimzelltumor im Kindesalter
- Chorionkarzinom des zentralen Nervensystems im Kindesalter
- embryonaler Tumor des Zentralnervensystems im Kindesalter
- Germinom des zentralen Nervensystems im Kindesalter
- gemischter Keimzelltumor des zentralen Nervensystems im Kindesalter
- Teratom des zentralen Nervensystems im Kindesalter
- Dottersacktumor des zentralen Nervensystems im Kindesalter
- rezidivierender embryonaler Tumor des Zentralnervensystems im Kindesalter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Nervensystems
- Neubildungen nach histologischem Typ
- Neubildungen nach Standort
- Neubildungen
- Neoplasmen, Keimzelle und Embryonal
- Neubildungen des Nervensystems
- Neubildungen des zentralen Nervensystems
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Antineoplastische Mittel, alkylierend
- Alkylierungsmittel
- Myeloablative Agonisten
- Antineoplastische Mittel, Phytogen
- Topoisomerase-II-Inhibitoren
- Topoisomerase-Inhibitoren
- Carboplatin
- Etoposid
- Ifosfamid
- Isophosphamidsenf
- Thiotepa
Andere Studien-ID-Nummern
- ACNS0122
- CDR0000257664 (Andere Kennung: Clinical Trials.gov)
- COG-ACNS0122 (Andere Kennung: Children's Oncology Group)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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