- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00006237
S0008: Kemoterapi Plus biologisk terapi til behandling af patienter med melanom
Fase III-forsøg med højdosis interferon Alfa 2-b versus cisplatin, vinblastin, DTIC Plus IL-2 og interferon hos patienter med højrisiko melanom
RATIONALE: Interferon alfa kan forstyrre væksten af kræftceller. Lægemidler, der bruges i kemoterapi, bruger forskellige måder til at stoppe tumorceller i at dele sig, så de holder op med at vokse eller dør. Interleukin-2 kan stimulere en persons hvide blodlegemer til at dræbe melanomceller. Det vides endnu ikke, om interferon alfa er mere effektivt med eller uden kombinationskemoterapi og interleukin-2 mod melanom.
FORMÅL: Randomiseret fase III-forsøg til at sammenligne effektiviteten af interferon alfa med eller uden kombinationskemoterapi bestående af cisplatin, vinblastin og dacarbazin plus interleukin-2 til behandling af patienter med melanom.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
MÅL:
- Sammenlign den samlede overlevelse og sygdomsfri overlevelse for patienter med højrisiko melanom behandlet med interferon alfa vs. cisplatin, vinblastin og dacarbazin plus interferon alfa og interleukin-2.
- Sammenlign de toksiske virkninger af disse behandlingsregimer hos disse patienter.
- Bestem forholdet mellem status for minimal residual sygdom (MRD) efter 12 uger og 52 uger og den samlede overlevelse af patienter behandlet med disse regimer.
- Sammenlign virkningerne af disse behandlingsregimer på disse patienters MRD-status.
- Bestem forholdet mellem kliniske karakteristika (antal involverede lymfeknuder, ulcererede primære og ekstrakapsulær forlængelse) og MRD hos patienter behandlet med disse regimer.
OVERSIGT: Dette er en randomiseret, multicenter undersøgelse. Patienterne er stratificeret efter nodal status (N1 eller N2 vs N3), graden af lymfeknudeinvolvering (kun mikrometastaser vs. eventuelle makrometastaser, inklusive satellit/in-transit metastaser) og ulceration af den primære tumor (ja vs nej vs ukendt primær) . Patienterne randomiseres til 1 ud af 2 behandlingsarme.
- Arm I: Patienter får interferon alfa IV på dag 1-5 i uge 1-4 efterfulgt af interferon alfa subkutant (SC) på dag 1, 3 og 5 i uge 5-52 i fravær af sygdomsprogression eller uacceptabel toksicitet.
- Arm II: Patienterne får cisplatin IV over 30 minutter efterfulgt af vinblastin IV på dag 1-4. Patienterne får også dacarbazin IV over 1 time på dag 1, interleukin-2 IV over 96 timer på dag 1-4 og interferon alfa SC på dag 1-5, 8, 10 og 12. Derudover får patienterne filgrastim (G-CSF) SC på dag 6-15. Behandlingen gentages hver 3. uge i 3 forløb i fravær af sygdomsprogression eller uacceptabel toksicitet.
Patienterne følges hver 3. måned i 2 år, hver 6. måned i 3 år og derefter årligt i 5 år.
PROJEKTERET TILSLUTNING: I alt 410 patienter (205 pr. behandlingsarm) vil blive akkumuleret til denne undersøgelse inden for 3 år.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Western Australia
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Perth, Western Australia, Australien, 6001
- Princess Margaret Hospital for Children
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
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Mobile, Alabama, Forenede Stater, 36652-2144
- Mobile Infirmary Medical Center
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Arizona
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Glendale, Arizona, Forenede Stater, 85306
- Banner Thunderbird Medical Center
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Phoenix, Arizona, Forenede Stater, 85016-7710
- Phoenix Children's Hospital
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Phoenix, Arizona, Forenede Stater, 85006
- Banner Good Samaritan Medical Center
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Phoenix, Arizona, Forenede Stater, 85006
- CCOP - Western Regional, Arizona
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Tucson, Arizona, Forenede Stater, 85724-5024
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Ft. Smith, Arkansas, Forenede Stater, 72903
- Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
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Little Rock, Arkansas, Forenede Stater, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Castro Valley, California, Forenede Stater, 94546
- Eden Medical Center
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Hayward, California, Forenede Stater, 94545
- Saint Rose Hospital
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La Jolla, California, Forenede Stater, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Oakland, California, Forenede Stater, 94609
- Alta Bates Summit Medical Center - Summit Campus
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Oakland, California, Forenede Stater, 94602
- Highland General Hospital
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Oakland, California, Forenede Stater, 94609
- CCOP - Bay Area Tumor Institute
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Pleasanton, California, Forenede Stater, 94588
- Valley Care Medical Center
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Sacramento, California, Forenede Stater, 95825
- Kaiser Permanente Medical Center - Oakland
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San Diego, California, Forenede Stater, 92161
- Veterans Affairs Medical Center - San Diego
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San Diego, California, Forenede Stater, 92121
- Scripps Cancer Center - San Diego
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San Pablo, California, Forenede Stater, 94806
- Doctors Medical Center - San Pablo Campus
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Sana Rosa, California, Forenede Stater, 95405
- CCOP - Santa Rosa Memorial Hospital
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Colorado
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Fort Collins, Colorado, Forenede Stater, 80524
- Poudre Valley Hospital
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Fort Collins, Colorado, Forenede Stater, 80528
- Front Range Cancer Specialists
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Connecticut
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Farmington, Connecticut, Forenede Stater, 06360-2875
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
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New Britain, Connecticut, Forenede Stater, 06050
- George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
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Norwich, Connecticut, Forenede Stater, 06360
- Eastern Connecticut Hematology and Oncology Associates
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Delaware
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Lewes, Delaware, Forenede Stater, 19958
- Tunnell Cancer Center at Beebe Medical Center
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Newark, Delaware, Forenede Stater, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20010-2970
- Children's National Medical Center
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Florida
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Jacksonville, Florida, Forenede Stater, 32207
- Baptist Cancer Institute - Jacksonville
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St. Petersburg, Florida, Forenede Stater, 33701
- All Children's Hospital
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Tampa, Florida, Forenede Stater, 33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
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West Palm Beach, Florida, Forenede Stater, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Altanta, Georgia, Forenede Stater, 30322
- Winship Cancer Institute of Emory University
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Decatur, Georgia, Forenede Stater, 30033
- Veterans Affairs Medical Center - Atlanta (Decatur)
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Valdosta, Georgia, Forenede Stater, 31603
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
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Idaho
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Boise, Idaho, Forenede Stater, 83712
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
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Illinois
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Aurora, Illinois, Forenede Stater, 60507
- Rush-Copley Cancer Care Center
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Bloomington, Illinois, Forenede Stater, 61701
- St. Joseph Medical Center
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Canton, Illinois, Forenede Stater, 61520
- Graham Hospital
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Carthage, Illinois, Forenede Stater, 62321
- Memorial Hospital
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Chicago, Illinois, Forenede Stater, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Chicago, Illinois, Forenede Stater, 60612-7243
- University of Illinois Cancer Center
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Chicago, Illinois, Forenede Stater, 60625
- Swedish Covenant Hospital
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Chicago, Illinois, Forenede Stater, 60611
- Hematology and Oncology Associates
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Chicago, Illinois, Forenede Stater, 60612
- Veterans Affairs Medical Center - Chicago Westside Hospital
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Chicago, Illinois, Forenede Stater, 60616
- Mercy Hospital and Medical Center
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Elgin, Illinois, Forenede Stater, 60120
- Sherman Hospital
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Eureka, Illinois, Forenede Stater, 61530
- Eureka Community Hospital
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Evanston, Illinois, Forenede Stater, 60201-1781
- Evanston Northwestern Healthcare - Evanston Hospital
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Galesburg, Illinois, Forenede Stater, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, Forenede Stater, 61401
- Galesburg Clinic, PC
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Havana, Illinois, Forenede Stater, 62644
- Mason District Hospital
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Hopedale, Illinois, Forenede Stater, 61747
- Hopedale Medical Complex
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Joliet, Illinois, Forenede Stater, 60435
- Joliet Oncology-Hematology Associates, Limited - West
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Joliet, Illinois, Forenede Stater, 60432
- Midwest Center for Hematology/Oncology
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Kewanee, Illinois, Forenede Stater, 61443
- Kewanee Hospital
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Macomb, Illinois, Forenede Stater, 61455
- Mcdonough District Hospital
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Maywood, Illinois, Forenede Stater, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Niles, Illinois, Forenede Stater, 60714
- Cancer Care and Hematology Specialists of Chicagoland - Niles
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Normal, Illinois, Forenede Stater, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Forenede Stater, 61761
- Community Cancer Center
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Ottawa, Illinois, Forenede Stater, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Forenede Stater, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, Forenede Stater, 61554
- Cancer Treatment Center at Pekin Hospital
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Peoria, Illinois, Forenede Stater, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Forenede Stater, 61637
- Saint Jude Midwest Affiliate
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Peoria, Illinois, Forenede Stater, 61614
- Proctor Hospital
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Peoria, Illinois, Forenede Stater, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, Forenede Stater, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Forenede Stater, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, Forenede Stater, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Forenede Stater, 61356
- Perry Memorial Hospital
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Rockford, Illinois, Forenede Stater, 61104-2315
- Swedish-American Regional Cancer Center
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Skokie, Illinois, Forenede Stater, 60076
- Hematology Oncology Associates - Skokie
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Skokie, Illinois, Forenede Stater, 60076
- Hematology/Oncology of the North Shore at Gross Point Medical Center
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Spring Valley, Illinois, Forenede Stater, 61362
- St. Margaret's Hospital
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Urbana, Illinois, Forenede Stater, 61801
- Carle Cancer Center at Carle Foundation Hospital
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Urbana, Illinois, Forenede Stater, 61801
- CCOP - Carle Cancer Center
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Indiana
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Elkhart, Indiana, Forenede Stater, 46515
- Elkhart General Hospital
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Kokomo, Indiana, Forenede Stater, 46904
- Howard Community Hospital
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La Porte, Indiana, Forenede Stater, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Michigan City, Indiana, Forenede Stater, 46360
- Saint Anthony Memorial Health Centers
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South Bend, Indiana, Forenede Stater, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Forenede Stater, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, Forenede Stater, 46617
- Saint Joseph Regional Medical Center
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Iowa
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Ames, Iowa, Forenede Stater, 50010
- McFarland Clinic, PC
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Davenport, Iowa, Forenede Stater, 52803
- Genesis Regional Cancer Center at Genesis Medical Center
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Des Moines, Iowa, Forenede Stater, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Forenede Stater, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Forenede Stater, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Forenede Stater, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Forenede Stater, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Forenede Stater, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Des Moines, Iowa, Forenede Stater, 50307
- Mercy Capitol Hospital
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Iowa City, Iowa, Forenede Stater, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Kansas
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Kansas City, Kansas, Forenede Stater, 64128
- Veterans Affairs Medical Center - Kansas City
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Salina, Kansas, Forenede Stater, 67401
- Tammy Walker Cancer Center at Salina Regional Health Center
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Topeka, Kansas, Forenede Stater, 66606
- Cotton-O'Neil Cancer Center
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Topeka, Kansas, Forenede Stater, 66606
- St. Francis Comprehensive Cancer Center
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Louisiana
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Monroe, Louisiana, Forenede Stater, 71210
- Louisiana State University Health Sciences Center - Monroe
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Shreveport, Louisiana, Forenede Stater, 71130-3932
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
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Maryland
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Elkton MD, Maryland, Forenede Stater, 21921
- Union Hospital Cancer Program at Union Hospital
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Forenede Stater, 02118
- Boston University Cancer Research Center
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Boston, Massachusetts, Forenede Stater, 02111
- Tufts-NEMC Cancer Center
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109-0942
- University of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, Forenede Stater, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, Forenede Stater, 48106
- CCOP - Michigan Cancer Research Consortium
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Battle Creek, Michigan, Forenede Stater, 49017
- Battle Creek Health System Cancer Care Center
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Big Rapids, Michigan, Forenede Stater, 49307
- Mecosta County Medical Center
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Dearborn, Michigan, Forenede Stater, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Detroit, Michigan, Forenede Stater, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Escanaba, Michigan, Forenede Stater, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, Forenede Stater, 48503
- Hurley Medical Center
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Flint, Michigan, Forenede Stater, 48503
- Genesys Hurley Cancer Institute
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Flint, Michigan, Forenede Stater, 48532
- Great Lakes Cancer Institute at McLaren Regional Medical Center
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Grand Rapids, Michigan, Forenede Stater, 49503
- Butterworth Hospital at Spectrum Health
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Grand Rapids, Michigan, Forenede Stater, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, Forenede Stater, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Grand Rapids, Michigan, Forenede Stater, 49506
- Metro Health Hospital
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Grosse Pointe Woods, Michigan, Forenede Stater, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Holland, Michigan, Forenede Stater, 49423
- Holland Community Hospital
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Iron Mountain, Michigan, Forenede Stater, 49801
- Dickinson County Healthcare System
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Jackson, Michigan, Forenede Stater, 49201
- Foote Memorial Hospital
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Kalamazoo, Michigan, Forenede Stater, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Forenede Stater, 49001
- Borgess Medical Center
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Kalamazoo, Michigan, Forenede Stater, 49007-3731
- West Michigan Cancer Center
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Lansing, Michigan, Forenede Stater, 48912-1811
- Sparrow Regional Cancer Center
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Marquette, Michigan, Forenede Stater, 49855
- Upper Michigan Cancer Center at Marquette General Hospital
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Muskegon, Michigan, Forenede Stater, 49442
- Hackley Hospital
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Royal Oak, Michigan, Forenede Stater, 48073
- William Beaumont Hospital - Royal Oak Campus
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Saginaw, Michigan, Forenede Stater, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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St. Joseph, Michigan, Forenede Stater, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
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Traverse City, Michigan, Forenede Stater, 49684
- Munson Medical Center
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Warren, Michigan, Forenede Stater, 48093
- St. John Macomb Hospital
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Minnesota
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Bemidji, Minnesota, Forenede Stater, 56601
- MeritCare Bemidji
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Burnsville, Minnesota, Forenede Stater, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Forenede Stater, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Forenede Stater, 55805
- CCOP - Duluth
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Duluth, Minnesota, Forenede Stater, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, Forenede Stater, 55805
- Miller - Dwan Medical Center
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Edina, Minnesota, Forenede Stater, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Forenede Stater, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Forenede Stater, 55350
- Hutchinson Area Health Care
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Lichfield, Minnesota, Forenede Stater, 55355
- Meeker County Memorial Hospital
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Maplewood, Minnesota, Forenede Stater, 55109
- Minnesota Oncology Hematology, PA - Maplewood
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Maplewood, Minnesota, Forenede Stater, 55109
- HealthEast Cancer Care at St. John's Hospital
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Minneapolis, Minnesota, Forenede Stater, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Minneapolis, Minnesota, Forenede Stater, 55415
- Hennepin County Medical Center - Minneapolis
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Robbinsdale, Minnesota, Forenede Stater, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- CCOP - Metro-Minnesota
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Shakopee, Minnesota, Forenede Stater, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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St Paul, Minnesota, Forenede Stater, 55102
- HealthEast Cancer Care at St. Joseph's Hospital
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St. Louis Park, Minnesota, Forenede Stater, 55416
- Park Nicollet Cancer Center
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St. Paul, Minnesota, Forenede Stater, 55102
- United Hospital
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St. Paul, Minnesota, Forenede Stater, 55101
- Regions Hospital Cancer Care Center
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Waconia, Minnesota, Forenede Stater, 55387
- Ridgeview Medical Center
-
Woodbury, Minnesota, Forenede Stater, 55125
- Minnesota Oncology Hematology, PA - Woodbury
-
Woodbury, Minnesota, Forenede Stater, 55125
- HealthEast Cancer Care at Woodwinds Health Campus
-
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Missouri
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Kansas City, Missouri, Forenede Stater, 64108
- Children's Mercy Hospital
-
Kansas City, Missouri, Forenede Stater, 64131
- CCOP - Kansas City
-
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Montana
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Billings, Montana, Forenede Stater, 59101
- CCOP - Montana Cancer Consortium
-
Billings, Montana, Forenede Stater, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Billings, Montana, Forenede Stater, 59101
- Northern Rockies Radiation Oncology Center
-
Billings, Montana, Forenede Stater, 59101
- St. Vincent Healthcare Cancer Care Services
-
Billings, Montana, Forenede Stater, 59107-7000
- Billings Clinic - Downtown
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Billings, Montana, Forenede Stater, 59107-5100
- Billings Clinic Cancer Center
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Bozeman, Montana, Forenede Stater, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, Forenede Stater, 59701
- St. James Healthcare Cancer Care
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Great Falls, Montana, Forenede Stater, 59405
- Great Falls Clinic - Main Facility
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Great Falls, Montana, Forenede Stater, 59405
-
Great Falls, Montana, Forenede Stater, 59405-5309
- Big Sky Oncology
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Great Falls, Montana, Forenede Stater, 59405
- Sletten Cancer Institute at Benefis Healthcare
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Helena, Montana, Forenede Stater, 59601
- St. Peter's Hospital
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Kalispell, Montana, Forenede Stater, 59901
- Kalispell Regional Medical Center
-
Kalispell, Montana, Forenede Stater, 59901
- Glacier Oncology, PLLC
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Kalispell, Montana, Forenede Stater, 59901
- Kalispell Medical Oncology at KRMC
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Missoula, Montana, Forenede Stater, 59801
- Community Medical Center
-
Missoula, Montana, Forenede Stater, 59804
- Guardian Oncology and Center for Wellness
-
Missoula, Montana, Forenede Stater, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
-
Missoula, Montana, Forenede Stater, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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Nebraska
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Kearney, Nebraska, Forenede Stater, 68848-1990
- Good Samaritan Cancer Center at Good Samaritan Hospital
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Lincoln, Nebraska, Forenede Stater, 68510
- Cancer Resource Center - Lincoln
-
Omaha, Nebraska, Forenede Stater, 68106
- CCOP - Missouri Valley Cancer Consortium
-
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
-
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New Jersey
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Marlton, New Jersey, Forenede Stater, 08053
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
-
Red Bank, New Jersey, Forenede Stater, 07701
- Booker Cancer Center at Riverview Medical Center
-
Voorhees, New Jersey, Forenede Stater, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
-
Voorhees, New Jersey, Forenede Stater, 08043
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
-
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87131-5636
- University of New Mexico Cancer Center
-
Albuquerque, New Mexico, Forenede Stater, 87108
- Lovelace Medical Center - Gibson
-
-
New York
-
East Syracuse, New York, Forenede Stater, 13057
- CCOP - Hematology-Oncology Associates of Central New York
-
Glens Falls, New York, Forenede Stater, 12801
- Adirondack Cancer Care - Glens Falls
-
Syracuse, New York, Forenede Stater, 13210
- SUNY Upstate Medical University Hospital
-
-
North Carolina
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Charlotte, North Carolina, Forenede Stater, 28233-3549
- Presbyterian Cancer Center at Presbyterian Hospital
-
Durham, North Carolina, Forenede Stater, 27710
- Duke Comprehensive Cancer Center
-
Goldsboro, North Carolina, Forenede Stater, 27534
- Wayne Memorial Hospital, Incorporated
-
-
North Dakota
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Fargo, North Dakota, Forenede Stater, 58122
- CCOP - MeritCare Hospital
-
Fargo, North Dakota, Forenede Stater, 58122
- MeritCare Broadway
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Ohio
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Canton, Ohio, Forenede Stater, 44708
- Mercy Cancer Center at Mercy Medical Center
-
Chillicothe, Ohio, Forenede Stater, 45601
- Adena Regional Medical Center
-
Cincinnati, Ohio, Forenede Stater, 45267
- Charles M. Barrett Cancer Center at University Hospital
-
Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Taussig Cancer Center
-
Cleveland, Ohio, Forenede Stater, 44109
- MetroHealth Cancer Care Center at MetroHealth Medical Center
-
Columbus, Ohio, Forenede Stater, 43214-3998
- Riverside Methodist Hospital Cancer Care
-
Columbus, Ohio, Forenede Stater, 43222
- Mount Carmel Health - West Hospital
-
Columbus, Ohio, Forenede Stater, 43210-1240
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
-
Columbus, Ohio, Forenede Stater, 43215
- CCOP - Columbus
-
Columbus, Ohio, Forenede Stater, 43215
- Grant Medical Center Cancer Care
-
Columbus, Ohio, Forenede Stater, 43228
- Doctors Hospital at Ohio Health
-
Delaware, Ohio, Forenede Stater, 43015
- Grady Memorial Hospital
-
Independence, Ohio, Forenede Stater, 44131
- Community Oncology Group at Cleveland Clinic Cancer Center
-
Lancaster, Ohio, Forenede Stater, 43130
- Fairfield Medical Center
-
Lima, Ohio, Forenede Stater, 45801
- St. Rita's Medical Center
-
Marietta, Ohio, Forenede Stater, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
-
Newark, Ohio, Forenede Stater, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
-
Springfield, Ohio, Forenede Stater, 45505
- Community Hospital of Springfield and Clark County
-
Springfield, Ohio, Forenede Stater, 45504
- Mercy Medical Center
-
Westerville, Ohio, Forenede Stater, 43081
- Mount Carmel St. Ann's Cancer Center
-
Wooster, Ohio, Forenede Stater, 44691
- Cleveland Clinic - Wooster
-
Zanesville, Ohio, Forenede Stater, 43701
- Genesis - Good Samaritan Hospital
-
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Oregon
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Gresham, Oregon, Forenede Stater, 97030
- Legacy Mount Hood Medical Center
-
Milwaukie, Oregon, Forenede Stater, 97222
- Providence Milwaukie Hospital
-
Portland, Oregon, Forenede Stater, 97216
- Adventist Medical Center
-
Portland, Oregon, Forenede Stater, 97210
- Legacy Good Samaritan Hospital & Comprehensive Cancer Center
-
Portland, Oregon, Forenede Stater, 97213-2967
- Providence Cancer Center at Providence Portland Medical Center
-
Portland, Oregon, Forenede Stater, 97225
- CCOP - Columbia River Oncology Program
-
Portland, Oregon, Forenede Stater, 97225
- Providence St. Vincent Medical Center
-
Portland, Oregon, Forenede Stater, 97227
- Legacy Emanuel Hospital and Health Center and Children's Hospital
-
Salem, Oregon, Forenede Stater, 97309-5014
- Salem Hospital Regional Cancer Care Services
-
Tualatin, Oregon, Forenede Stater, 97062
- Legacy Meridian Park Hospital
-
-
Pennsylvania
-
Allentown, Pennsylvania, Forenede Stater, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
-
Danville, Pennsylvania, Forenede Stater, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
-
Hershey, Pennsylvania, Forenede Stater, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
-
Lemoyne, Pennsylvania, Forenede Stater, 17043
- Central Pennsylvania Hematology and Medical Oncology Associates, PC
-
Lewistown, Pennsylvania, Forenede Stater, 17044
- Lewistown Hospital
-
Philadelphia, Pennsylvania, Forenede Stater, 19134-1095
- St. Christopher's Hospital for Children
-
Pittsburgh, Pennsylvania, Forenede Stater, 15232
- UPMC Cancer Centers
-
State College, Pennsylvania, Forenede Stater, 16803
- Mount Nittany Medical Center
-
State College, Pennsylvania, Forenede Stater, 16801
- Geisinger Medical Group - Scenery Park
-
Wilkes-Barre, Pennsylvania, Forenede Stater, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater, 29401
- Roper St. Francis Cancer Center at Roper Hospital
-
Columbia, South Carolina, Forenede Stater, 29203
- Palmetto Health South Carolina Cancer Center
-
Greenville, South Carolina, Forenede Stater, 29615
- CCOP - Greenville
-
-
South Dakota
-
Sioux Falls, South Dakota, Forenede Stater, 57105
- Avera Cancer Institute
-
Sioux Falls, South Dakota, Forenede Stater, 57105
- Medical X-Ray Center, PC
-
Sioux Falls, South Dakota, Forenede Stater, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
-
-
Tennessee
-
Knoxville, Tennessee, Forenede Stater, 37916
- Thompson Cancer Survival Center
-
Memphis, Tennessee, Forenede Stater, 38104
- University of Tennessee Cancer Institute - Memphis
-
Nashville, Tennessee, Forenede Stater, 37232-6838
- Vanderbilt-Ingram Cancer Center
-
-
Texas
-
Amarillo, Texas, Forenede Stater, 79106
- Harrington Cancer Center
-
Fort Sam Houston, Texas, Forenede Stater, 78234-6200
- Brooke Army Medical Center
-
Fort Worth, Texas, Forenede Stater, 76104
- Cook Children's Medical Center - Fort Worth
-
Lackland AFB, Texas, Forenede Stater, 78236
- Wilford Hall Medical Center
-
San Antonio, Texas, Forenede Stater, 78207
- University of Texas Health Science Center at San Antonio
-
Temple, Texas, Forenede Stater, 76508
- CCOP - Scott and White Hospital
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84113-1100
- Primary Children's Medical Center
-
Salt Lake City, Utah, Forenede Stater, 84112
- Huntsman Cancer Institute at University of Utah
-
-
Virginia
-
Charlottesville, Virginia, Forenede Stater, 22901
- Martha Jefferson Hospital Cancer Care Center
-
-
Washington
-
Auburn, Washington, Forenede Stater, 98002
- Auburn Regional Center for Cancer Care
-
Bellingham, Washington, Forenede Stater, 98225
- St. Joseph Cancer Center
-
Bremerton, Washington, Forenede Stater, 98310
- Olympic Hematology and Oncology
-
Centralia, Washington, Forenede Stater, 98531-9027
- Providence Centralia Hospital
-
Federal Way, Washington, Forenede Stater, 98003
- St. Francis Hospital
-
Mt. Vernon, Washington, Forenede Stater, 98273
- Skagit Valley Hospital Cancer Care Center
-
Olympia, Washington, Forenede Stater, 98506-5166
- Providence St. Peter Hospital Regional Cancer Center
-
Puyallup, Washington, Forenede Stater, 98372
- Good Samaritan Cancer Center
-
Seattle, Washington, Forenede Stater, 98104
- Harborview Medical Center
-
Seattle, Washington, Forenede Stater, 98104
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, Forenede Stater, 98104
- Minor and James Medical, PLLC
-
Seattle, Washington, Forenede Stater, 98112
- Group Health Central Hospital
-
Seattle, Washington, Forenede Stater, 98122-4307
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
-
Seattle, Washington, Forenede Stater, 98122
- Polyclinic First Hill
-
Seattle, Washington, Forenede Stater, 98195-6043
- University Cancer Center at University of Washington Medical Center
-
Spokane, Washington, Forenede Stater, 99202
- Cancer Care Northwest - Spokane South
-
Tacoma, Washington, Forenede Stater, 98405-3004
- Franciscan Cancer Center at St. Joseph Medical Center
-
Tacoma, Washington, Forenede Stater, 98405
- Allenmore Hospital
-
Tacoma, Washington, Forenede Stater, 98405
- CCOP - Northwest
-
Tacoma, Washington, Forenede Stater, 98405
- MultiCare Regional Cancer Center at Tacoma General Hospital
-
Tacoma, Washington, Forenede Stater, 98499
- St. Clare Hospital
-
Vancouver, Washington, Forenede Stater, 98668
- Southwest Washington Medical Center Cancer Center
-
Wenatchee, Washington, Forenede Stater, 98801-2028
- Wenatchee Valley Medical Center
-
-
West Virginia
-
Charleston, West Virginia, Forenede Stater, 25304
- West Virginia University Health Sciences Center - Charleston
-
Parkersburg, West Virginia, Forenede Stater, 26102
- Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
-
-
Wisconsin
-
Appleton, Wisconsin, Forenede Stater, 54911-3496
- Fox Valley Hematology and Oncology - East Grant Street
-
Green Bay, Wisconsin, Forenede Stater, 54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, Forenede Stater, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, Forenede Stater, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay, Wisconsin, Forenede Stater, 54303
- St. Mary's Hospital Medical Center - Green Bay
-
La Crosse, Wisconsin, Forenede Stater, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
-
Madison, Wisconsin, Forenede Stater, 53792-6164
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
-
Marinette, Wisconsin, Forenede Stater, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
-
Oconto Falls, Wisconsin, Forenede Stater, 54154
- Green Bay Oncology, Limited - Oconto Falls
-
Sturgeon Bay, Wisconsin, Forenede Stater, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
-
-
Wyoming
-
Sheridan, Wyoming, Forenede Stater, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
SYGDOMS KARAKTERISTIKA:
Histologisk bevist melanom af kutan oprindelse eller fra ukendt primær ved indledende præsentation af primært eller første klinisk påvist nodal eller satellit/in-transit recidiv
- Ingen fjernmetastaser
- Intet melanom af okulær, slimhinde eller anden ikke-kutan oprindelse
Et af følgende kriterier skal gælde for patienter med nydiagnosticeret melanom ELLER en tidligere diagnosticeret primær med aktuel efterfølgende, klinisk, regional knudesygdom og/eller satellit-/transitsygdom:
- Ulcereret primært melanom med 1 eller flere involverede lymfeknuder (mikro/okkult eller makro/klinisk åbenlys)
Ikke-ulcereret eller ukendt primært melanom med en makro/klinisk åbenlys lymfeknudemetastase, inklusive en enkelt sammenfiltret knude
- Ingen ikke-ulcereret eller ukendt primær tumor og en enkelt mikrometastatisk lymfeknude
- Ikke-ulcereret melanom med to eller flere lymfeknudemetastaser (mikro/okkult eller makro/klinisk åbenlyse) og/eller sammenvoksede noder
- Enhver satellit/transitmetastase med eller uden lymfeknudepåvirkning
- Patienter med recidiverende sygdom skal have recidiverende sygdom i det regionale nodalbassin af en forudgående komplet lymfadenektomi
- Involvering af flere regionale nodalbassiner tilladt, hvis de er passende anatomiske drænbassiner til det primære sted
Patienter skal være sygdomsfri på tidspunktet for indskrivning baseret på følgende kirurgiske kriterier:
- Patienter ved den første præsentation af melanom skal gennemgå tilstrækkelig bred udskæring af primær læsion
- Patienter med tidligere diagnosticeret melanom skal have resekeret al sygdom med patologisk negative marginer og ingen sygdom på primært sted eller anden resektion af primær
- Fuld lymfadenektomi påkrævet af alle patienter, inklusive dem med positive sentinel noder eller positiv satellit/in-transit metastase
- Ikke mere end 56 dage siden forudgående lymfadenektomi ELLER operation for at fjerne tilbagevendende sygdom efter forudgående fuldstændig lymfadenektomi
- Skal være villig til at deltage i minimale restsygdomsundersøgelser, hvis de er registreret på undersøgelsen den 3/1/2003 eller senere
PATIENT KARAKTERISTIKA:
Alder:
- 18 og derover
Ydeevnestatus:
- Zubrod 0-1
Forventede levealder:
- Ikke specificeret
Hæmatopoietisk:
- Absolut granulocyttal mindst 1.500/mm^3
- Blodpladetal mindst 100.000/mm^3
Hepatisk:
- Bilirubin ikke større end 1,5 gange øvre normalgrænse (ULN)
- SGOT eller SGPT ikke mere end 2 gange ULN
- LDH og alkalisk fosfatase ikke mere end 2 gange ULN (over normal værdi kræver en kontrastforstærket CT-scanning eller MRI af lever)
- Ingen kendt nylig hepatitispositivitet ved PCR
Nyre:
- Kreatinin ikke større end 1,5 mg/dL ELLER
- Kreatininclearance mindst 75 ml/min
Kardiovaskulær:
- Ingen kongestiv hjertesvigt
- Ingen koronararteriesygdom
- Ingen alvorlig hjertearytmi
- Ingen tidligere myokardieinfarkt
Normal hjertestresstest påkrævet, hvis nogen af følgende er til stede:
- Over 50 år
- Unormalt EKG
- Anamnese med hjertesygdom
Lunge:
- Ingen symptomatisk lungesygdom
Andet:
- Ikke gravid eller ammende
- Negativ graviditetstest
- Fertile patienter skal bruge effektiv prævention
- Ingen autoimmune lidelser eller tilstande af immunsuppression
Ingen anden tidligere malignitet inden for de seneste 5 år bortset fra følgende:
- Tilstrækkeligt behandlet basalcelle- eller pladecellehudkræft
- Carcinom in situ af livmoderhalsen
- Tilstrækkeligt behandlet stadium I eller II cancer i remission
- HIV negativ
- Intet kendt AIDS eller HIV-1 associeret kompleks
FORUDSÆTNING SAMTYDLIG TERAPI:
Biologisk terapi:
- Ingen tidligere immunterapi, inklusive interferon, interleukin, levamisol eller andre biologiske responsmodifikatorer
- Ingen anden samtidig biologisk behandling
Kemoterapi:
- Ingen forudgående kemoterapi (inklusive infusions- eller perfusionsbehandling)
- Ingen anden samtidig kemoterapi
Endokrin terapi:
- Ingen samtidige systemiske kortikosteroider eller topiske steroidcremer
- Samtidige steroid-antihistaminer tilladt, hvis der ikke er noget alternativ
- Ingen samtidig hormonbehandling
Strålebehandling:
Ingen forudgående strålebehandling
- Forudgående postlumpektomi strålebehandling for brystkræft tilladt
- Ingen samtidig strålebehandling
Kirurgi:
- Se Sygdomskarakteristika
- Ingen samtidig operation
Andet:
- Ingen samtidig antihypertensiv medicin (kun arm II)
- Ingen samtidige immunsuppressive midler
- Ingen anden samtidig anticancerterapi
- Antihistaminer tilladt, hvis ingen alternativ medicin er egnet
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Arm I
Patienter får interferon alfa IV på dag 1-5 i uge 1-4 efterfulgt af interferon alfa subkutant (SC) på dag 1, 3 og 5 i uge 5-52 i fravær af sygdomsprogression eller uacceptabel toksicitet.
|
Gives IV og subkutant
|
|
Eksperimentel: Arm II
Patienterne får cisplatin IV over 30 minutter efterfulgt af vinblastin IV på dag 1-4.
Patienterne får også dacarbazin IV over 1 time på dag 1, interleukin-2 IV over 96 timer på dag 1-4 og interferon alfa SC på dag 1-5, 8, 10 og 12.
Derudover får patienterne filgrastim (G-CSF) SC på dag 6-15.
Behandlingen gentages hver 3. uge i 3 forløb i fravær af sygdomsprogression eller uacceptabel toksicitet.
|
Givet IV
Givet IV
Gives subkutant
Gives IV og subkutant
Givet IV
Andre navne:
Givet IV
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
5-års samlet overlevelse
Tidsramme: Hver tredje måned i et år, hver sjette måned i år 2-5, årlig i år 5-10
|
Samlet overlevelse blev målt fra registreringsdatoen til undersøgelsen indtil døden af enhver årsag med observationer censureret på datoen for sidste kontakt for patienter, der sidst var kendt for at være i live.
|
Hver tredje måned i et år, hver sjette måned i år 2-5, årlig i år 5-10
|
|
5-års tilbagefaldsfri overlevelse
Tidsramme: Hver tredje måned det første år, hver 6. måned i år 2-5, årligt i år 6-10
|
Målt fra registreringsdatoen til datoen for første observation af progressiv sygdom eller dødsfald på grund af en hvilken som helst årsag.
|
Hver tredje måned det første år, hver 6. måned i år 2-5, årligt i år 6-10
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Toksicitet
Tidsramme: Mens de var i behandling, blev patienter i HDIFN-armen vurderet ugentligt i den 1. måned, derefter hver 2. uge i den 2. måned og derefter hver 3. måned. patienter på biokemo-armen blev vurderet dagligt i de 1. 5 dage og derefter ugentligt.
|
Antal patienter med uønskede hændelser af grad 3-5, der er relateret til undersøgelseslægemidlet efter given type bivirkning
|
Mens de var i behandling, blev patienter i HDIFN-armen vurderet ugentligt i den 1. måned, derefter hver 2. uge i den 2. måned og derefter hver 3. måned. patienter på biokemo-armen blev vurderet dagligt i de 1. 5 dage og derefter ugentligt.
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Lawrence E. Flaherty, MD, Barbara Ann Karmanos Cancer Institute
- Studiestol: Michael B. Atkins, MD, Beth Israel Deaconess Medical Center
- Ledende efterforsker: John A. Thompson, MD, Seattle Cancer Care Alliance
- Ledende efterforsker: John T. Vetto, MD, FACS, OHSU Knight Cancer Institute
- Ledende efterforsker: John M. Kirkwood, MD, University of Pittsburgh
- Studiestol: Frank Haluska, MD, PhD, Massachusetts General Hospital
- Ledende efterforsker: Alberto S. Pappo, MD, Texas Children's Cancer Center
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Neuroendokrine tumorer
- Nevi og melanomer
- Melanom
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Agenter fra det perifere nervesystem
- Antivirale midler
- Anti-HIV-midler
- Anti-retrovirale midler
- Analgetika
- Sensoriske systemagenter
- Analgetika, ikke-narkotisk
- Antineoplastiske midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Antineoplastiske midler, fytogene
- Interferoner
- Interferon-alfa
- Aldesleukin
- Cisplatin
- Dacarbazin
- Interleukin-2
- Vinblastin
Andre undersøgelses-id-numre
- S0008 (Anden identifikator: SWOG)
- U10CA032102 (U.S. NIH-bevilling/kontrakt)
- CALGB-500002 (Anden identifikator: CALGB)
- ECOG-S0008 (Anden identifikator: ECOG)
- COG-S0008 (Anden identifikator: COG)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Melanom (hud)
-
Alma LasersTrukket tilbageSkin ResurfacingForenede Stater
-
R2 DermatologyAfsluttet
-
Bausch Health Americas, Inc.Aktiv, ikke rekrutterendeSkin ResurfacingForenede Stater
-
Syneron MedicalAfsluttetSkin Resurfacing | RynkereduktionForenede Stater, Canada
-
National Cancer Institute (NCI)ExelisisAfsluttetStage IV Uveal Melanoma AJCC v7 | Tilbagevendende uveal melanom | Stage III Uveal Melanoma AJCC v7 | Stage IIIA Uveal Melanoma AJCC v7 | Stadie IIIB Uveal Melanoma AJCC v7 | Stage IIIC Uveal Melanoma AJCC v7Forenede Stater, Canada
-
University of Split, School of MedicineAfsluttetSkin Recovery i forskellige humane hudskademodellerKroatien
-
Centre Hospitalier le MansRekruttering
-
Superior UniversityAktiv, ikke rekrutterendePeeling Skin SyndromePakistan
-
University of ArizonaIkke rekrutterer endnuGruppe 1: Carrier Care (CC) efterfulgt af hud-til-hud-pleje (SSC) efterfulgt af familievalg | Gruppe 2: Skin-to-Skin Care (SSC) efterfulgt af Carrier Care (CC) efterfulgt af familievalg
-
The First Affiliated Hospital of Dalian Medical...UkendtSår og skader | Trauma | Brud, åben | Skin ExpanderKina
Kliniske forsøg med cisplatin
-
West China Second University HospitalRekrutteringNeoadjuverende kemoterapi | Epitelkarcinom, ovarieKina
-
Insmed IncorporatedAfsluttetOsteosarkom MetastatiskForenede Stater
-
Privo TechnologiesNational Cancer Institute (NCI)AfsluttetOralt planocellulært karcinomForenede Stater
-
London Health Sciences Centre Research Institute...RekrutteringLokalt avanceret hoved- og halspladecellekarcinomCanada
-
Taiho Oncology, Inc.Quintiles, Inc.AfsluttetMavekræftForenede Stater, Canada
-
Cedars-Sinai Medical CenterAktiv, ikke rekrutterendeHPV-positivt orofaryngealt planocellulært karcinomForenede Stater
-
Sun Yat-sen UniversityAktiv, ikke rekrutterendeNasopharyngealt karcinomKina
-
Bangabandhu Sheikh Mujib Medical University, Dhaka...Afsluttet
-
Taiho Pharmaceutical Co., Ltd.AfsluttetLivmoderhalskræftJapan, Korea, Republikken, Taiwan
-
Fujian Cancer HospitalIkke rekrutterer endnuNasopharyngealt karcinomKina