Tipifarnib för behandling av avancerade solida tumörer, lymfom eller histiocytiska störningar med HRAS-genförändringar, en Pediatric MATCH Treatment Trial
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Fas 2-underprotokoll för Tipifarnib hos patienter med tumörer som har genomiska HRAS-förändringar
This phase II pediatric MATCH trial studies how well tipifarnib works in treating patients with solid tumors that have recurred or spread to other places in the body (advanced), lymphoma, or histiocytic disorders, that have a genetic alteration in the gene HRAS. Tipifarnib may block the growth of cancer cells that have specific genetic changes in a gene called HRAS and may reduce tumor size.
Studieöversikt
Status
Betingelser
- Malign fast neoplasma
- Återkommande melanom
- Återkommande Ependymom
- Återkommande Ewing Sarkom
- Återkommande hepatoblastom
- Återkommande Langerhans cell Histiocytos
- Återkommande maligna könscellstumörer
- Återkommande malignt gliom
- Återkommande medulloblastom
- Återkommande neuroblastom
- Återkommande non-Hodgkin lymfom
- Återkommande osteosarkom
- Återkommande perifer primitiv neuroektodermal tumör
- Återkommande rhabdoidtumör
- Återkommande rabdomyosarkom
- Återkommande mjukdelssarkom
- Återkommande WHO Grad 2 Gliom
- Refraktär Ependymom
- Eldfast Ewing Sarkom
- Refraktärt hepatoblastom
- Refraktär Langerhans Cell Histiocytos
- Refraktär malign könscellstumör
- Refraktärt malignt gliom
- Refraktär medulloblastom
- Refraktär neuroblastom
- Refraktärt non-Hodgkin lymfom
- Refraktär osteosarkom
- Refraktär perifer primitiv neuroektodermal tumör
- Refraktär Rhabdoid tumör
- Refraktär Rhabdomyosarkom
- Eldfast mjukvävnadssarkom
- Refraktär WHO Grad 2 Gliom
- Återkommande sköldkörtelkarcinom
- Refraktärt melanom
- Återkommande binjurefeokromocytom
- Återkommande ektomesenkymom
- Återkommande njure Wilms-tumör
- Återkommande rhabdoidtumör i njuren
- Refraktär binjurekörtelfeokromocytom
- Refraktär rhabdoidtumör i njuren
- Refraktär sköldkörtelkarcinom
Intervention / Behandling
Detaljerad beskrivning
PRIMARY OBJECTIVE:
I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with tipifarnib with advanced solid tumors (including central nervous system [CNS] tumors), lymphomas or histiocytic disorders that harbor activating genetic alterations in HRAS.
SECONDARY OBJECTIVES:
I. To estimate the progression free survival in pediatric patients treated with tipifarnib with advanced solid tumors (including CNS tumors), lymphomas or histiocytic disorders that harbor activating genetic alterations in HRAS.
II. To obtain information about the tolerability of tipifarnib in children and adolescents with relapsed or refractory cancer.
EXPLORATORY OBJECTIVES:
I. To evaluate other biomarkers as predictors of response to tipifarnib and specifically, whether tumors that harbor different missense mutations or variant allele frequency will demonstrate differential response to tipifarnib treatment.
II. To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA).
OUTLINE:
Patients receive tipifarnib tablets 350 mg/m^2/dose orally (PO) or via nasogastric or gastric tube twice daily (BID) (maximum 600 mg/dose BID) with food on days 1-7 and 15-21. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, then periodically thereafter.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35233
- Children's Hospital of Alabama
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Alaska
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Anchorage, Alaska, Förenta staterna, 99508
- Providence Alaska Medical Center
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Arizona
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Mesa, Arizona, Förenta staterna, 85202
- Banner Children's at Desert
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Phoenix, Arizona, Förenta staterna, 85016
- Phoenix Childrens Hospital
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Tucson, Arizona, Förenta staterna, 85719
- Banner University Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, Förenta staterna, 72202-3591
- Arkansas Children's Hospital
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California
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Downey, California, Förenta staterna, 90242
- Kaiser Permanente Downey Medical Center
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Duarte, California, Förenta staterna, 91010
- City of Hope Comprehensive Cancer Center
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Loma Linda, California, Förenta staterna, 92354
- Loma Linda University Medical Center
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Long Beach, California, Förenta staterna, 90806
- Miller Children's and Women's Hospital Long Beach
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Los Angeles, California, Förenta staterna, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, Förenta staterna, 90027
- Children's Hospital Los Angeles
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Los Angeles, California, Förenta staterna, 90095
- Mattel Children's Hospital UCLA
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Madera, California, Förenta staterna, 93636
- Valley Children's Hospital
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Oakland, California, Förenta staterna, 94609
- UCSF Benioff Children's Hospital Oakland
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Oakland, California, Förenta staterna, 94611
- Kaiser Permanente-Oakland
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Orange, California, Förenta staterna, 92868
- Children's Hospital of Orange County
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Palo Alto, California, Förenta staterna, 94304
- Lucile Packard Children's Hospital Stanford University
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Sacramento, California, Förenta staterna, 95817
- University of California Davis Comprehensive Cancer Center
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San Diego, California, Förenta staterna, 92123
- Rady Children's Hospital - San Diego
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San Diego, California, Förenta staterna, 92134
- Naval Medical Center -San Diego
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San Francisco, California, Förenta staterna, 94158
- UCSF Medical Center-Mission Bay
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Torrance, California, Förenta staterna, 90502
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
- Children's Hospital Colorado
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Denver, Colorado, Förenta staterna, 80218
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
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Connecticut
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Hartford, Connecticut, Förenta staterna, 06106
- Connecticut Children's Medical Center
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New Haven, Connecticut, Förenta staterna, 06520
- Yale University
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Delaware
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Wilmington, Delaware, Förenta staterna, 19803
- Alfred I duPont Hospital for Children
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District of Columbia
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Washington D.C., District of Columbia, Förenta staterna, 20010
- Children's National Medical Center
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Washington D.C., District of Columbia, Förenta staterna, 20007
- MedStar Georgetown University Hospital
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Florida
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Fort Lauderdale, Florida, Förenta staterna, 33316
- Broward Health Medical Center
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Fort Myers, Florida, Förenta staterna, 33908
- Golisano Children's Hospital of Southwest Florida
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Gainesville, Florida, Förenta staterna, 32610
- UF Health Cancer Institute - Gainesville
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Hollywood, Florida, Förenta staterna, 33021
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
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Jacksonville, Florida, Förenta staterna, 32207
- Nemours Children's Clinic-Jacksonville
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Miami, Florida, Förenta staterna, 33155
- Nicklaus Children's Hospital
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Miami, Florida, Förenta staterna, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Miami, Florida, Förenta staterna, 33176
- Miami Cancer Institute
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Orlando, Florida, Förenta staterna, 32827
- Nemours Children's Hospital
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Orlando, Florida, Förenta staterna, 32803
- AdventHealth Orlando
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Orlando, Florida, Förenta staterna, 32806
- Arnold Palmer Hospital for Children
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Pensacola, Florida, Förenta staterna, 32504
- Sacred Heart Hospital
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St. Petersburg, Florida, Förenta staterna, 33701
- Johns Hopkins All Children's Hospital
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Tampa, Florida, Förenta staterna, 33606
- Tampa General Hospital
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Tampa, Florida, Förenta staterna, 33607
- Saint Joseph's Hospital/Children's Hospital-Tampa
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West Palm Beach, Florida, Förenta staterna, 33407
- Saint Mary's Medical Center
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Georgia
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Atlanta, Georgia, Förenta staterna, 30329
- Children's Healthcare of Atlanta - Arthur M Blank Hospital
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Savannah, Georgia, Förenta staterna, 31404
- Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, Förenta staterna, 96826
- Kapiolani Medical Center for Women and Children
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Idaho
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Boise, Idaho, Förenta staterna, 83712
- Saint Luke's Cancer Institute - Boise
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Illinois
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Chicago, Illinois, Förenta staterna, 60637
- University of Chicago Comprehensive Cancer Center
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Chicago, Illinois, Förenta staterna, 60612
- University of Illinois
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Chicago, Illinois, Förenta staterna, 60611
- Lurie Children's Hospital-Chicago
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Maywood, Illinois, Förenta staterna, 60153
- Loyola University Medical Center
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Peoria, Illinois, Förenta staterna, 61637
- OSF Children's Hospital of Illinois
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Springfield, Illinois, Förenta staterna, 62702
- Southern Illinois University School of Medicine
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Indiana
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Indianapolis, Indiana, Förenta staterna, 46202
- Riley Hospital for Children
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Indianapolis, Indiana, Förenta staterna, 46260
- Ascension Saint Vincent Indianapolis Hospital
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Iowa
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Des Moines, Iowa, Förenta staterna, 50309
- Blank Children's Hospital
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Iowa City, Iowa, Förenta staterna, 52242
- University of Iowa/Holden Comprehensive Cancer Center
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40536
- University of Kentucky/Markey Cancer Center
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Louisville, Kentucky, Förenta staterna, 40202
- Norton Children's Hospital
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Louisiana
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New Orleans, Louisiana, Förenta staterna, 70121
- Ochsner Medical Center Jefferson
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New Orleans, Louisiana, Förenta staterna, 70118
- Children's Hospital New Orleans
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Maine
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Bangor, Maine, Förenta staterna, 04401
- Eastern Maine Medical Center
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Scarborough, Maine, Förenta staterna, 04074
- Maine Children's Cancer Program
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Maryland
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Baltimore, Maryland, Förenta staterna, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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Baltimore, Maryland, Förenta staterna, 21215
- Sinai Hospital of Baltimore
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Baltimore, Maryland, Förenta staterna, 21201
- University of Maryland/Greenebaum Cancer Center
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Bethesda, Maryland, Förenta staterna, 20892
- National Institutes of Health Clinical Center
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Förenta staterna, 02114
- Massachusetts General Hospital Cancer Center
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Worcester, Massachusetts, Förenta staterna, 01655
- UMass Memorial Medical Center - University Campus
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48109
- C S Mott Children's Hospital
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Detroit, Michigan, Förenta staterna, 48201
- Children's Hospital of Michigan
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Detroit, Michigan, Förenta staterna, 48201
- Wayne State University/Karmanos Cancer Institute
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East Lansing, Michigan, Förenta staterna, 48823
- Michigan State University
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Grand Rapids, Michigan, Förenta staterna, 49503
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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Kalamazoo, Michigan, Förenta staterna, 49007
- Bronson Methodist Hospital
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Royal Oak, Michigan, Förenta staterna, 48073
- Corewell Health Children's
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Minneapolis, Minnesota, Förenta staterna, 55455
- University of Minnesota/Masonic Cancer Center
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Mississippi
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Jackson, Mississippi, Förenta staterna, 39216
- University of Mississippi Medical Center
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Missouri
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Kansas City, Missouri, Förenta staterna, 64108
- Children's Mercy Hospitals and Clinics
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St Louis, Missouri, Förenta staterna, 63110
- Washington University School of Medicine
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St Louis, Missouri, Förenta staterna, 63141
- Mercy Hospital Saint Louis
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St Louis, Missouri, Förenta staterna, 63104
- Cardinal Glennon Children's Medical Center
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Nebraska
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Omaha, Nebraska, Förenta staterna, 68198
- University of Nebraska Medical Center
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Omaha, Nebraska, Förenta staterna, 68114
- Children's Hospital and Medical Center of Omaha
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89144
- Summerlin Hospital Medical Center
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Las Vegas, Nevada, Förenta staterna, 89109
- Sunrise Hospital and Medical Center
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Las Vegas, Nevada, Förenta staterna, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Las Vegas, Nevada, Förenta staterna, 89102
- University Medical Center of Southern Nevada
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Reno, Nevada, Förenta staterna, 89502
- Renown Regional Medical Center
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New Hampshire
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Lebanon, New Hampshire, Förenta staterna, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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New Jersey
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Hackensack, New Jersey, Förenta staterna, 07601
- Hackensack University Medical Center
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Morristown, New Jersey, Förenta staterna, 07960
- Morristown Medical Center
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New Brunswick, New Jersey, Förenta staterna, 08901
- Saint Peter's University Hospital
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New Brunswick, New Jersey, Förenta staterna, 08903
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
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New York
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Albany, New York, Förenta staterna, 12208
- Albany Medical Center
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Buffalo, New York, Förenta staterna, 14263
- Roswell Park Cancer Institute
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Mineola, New York, Förenta staterna, 11501
- NYU Langone Hospital - Long Island
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New Hyde Park, New York, Förenta staterna, 11040
- The Steven and Alexandra Cohen Children's Medical Center of New York
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New York, New York, Förenta staterna, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, Förenta staterna, 10032
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
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New York, New York, Förenta staterna, 10065
- NYP/Weill Cornell Medical Center
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New York, New York, Förenta staterna, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
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Rochester, New York, Förenta staterna, 14642
- University of Rochester
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Stony Brook, New York, Förenta staterna, 11794
- Stony Brook University Medical Center
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Syracuse, New York, Förenta staterna, 13210
- State University of New York Upstate Medical University
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The Bronx, New York, Förenta staterna, 10467
- Montefiore Medical Center - Moses Campus
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Valhalla, New York, Förenta staterna, 10595
- New York Medical College
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North Carolina
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Asheville, North Carolina, Förenta staterna, 28801
- Mission Hospital
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Chapel Hill, North Carolina, Förenta staterna, 27599
- UNC Lineberger Comprehensive Cancer Center
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Charlotte, North Carolina, Förenta staterna, 28203
- Carolinas Medical Center/Levine Cancer Institute
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Charlotte, North Carolina, Förenta staterna, 28204
- Novant Health Presbyterian Medical Center
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Durham, North Carolina, Förenta staterna, 27710
- Duke University Medical Center
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Greenville, North Carolina, Förenta staterna, 27834
- East Carolina University
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Winston-Salem, North Carolina, Förenta staterna, 27157
- Wake Forest University Health Sciences
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North Dakota
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Fargo, North Dakota, Förenta staterna, 58122
- Sanford Broadway Medical Center
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Ohio
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Akron, Ohio, Förenta staterna, 44308
- Children's Hospital Medical Center of Akron
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Cincinnati, Ohio, Förenta staterna, 45229
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic Foundation
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Cleveland, Ohio, Förenta staterna, 44106
- Rainbow Babies and Childrens Hospital
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Columbus, Ohio, Förenta staterna, 43205
- Nationwide Children's Hospital
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Dayton, Ohio, Förenta staterna, 45404
- Dayton Children's Hospital
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Toledo, Ohio, Förenta staterna, 43606
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73104
- University of Oklahoma Health Sciences Center
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Oregon
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Portland, Oregon, Förenta staterna, 97239
- Oregon Health and Science University
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Portland, Oregon, Förenta staterna, 97227
- Legacy Emanuel Children's Hospital
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Pennsylvania
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Allentown, Pennsylvania, Förenta staterna, 18103
- Lehigh Valley Hospital-Cedar Crest
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Danville, Pennsylvania, Förenta staterna, 17822
- Geisinger Medical Center
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, Förenta staterna, 19134
- Saint Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, Förenta staterna, 15224
- Children's Hospital of Pittsburgh of UPMC
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Rhode Island
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Providence, Rhode Island, Förenta staterna, 02903
- Rhode Island Hospital
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South Carolina
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Columbia, South Carolina, Förenta staterna, 29203
- Prisma Health Richland Hospital
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Greenville, South Carolina, Förenta staterna, 29605
- BI-LO Charities Children's Cancer Center
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South Dakota
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Sioux Falls, South Dakota, Förenta staterna, 57117-5134
- Sanford USD Medical Center - Sioux Falls
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Tennessee
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Chattanooga, Tennessee, Förenta staterna, 37403
- T C Thompson Children's Hospital
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Knoxville, Tennessee, Förenta staterna, 37916
- East Tennessee Childrens Hospital
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Memphis, Tennessee, Förenta staterna, 38105
- Saint Jude Children's Research Hospital
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Nashville, Tennessee, Förenta staterna, 37232
- Vanderbilt University/Ingram Cancer Center
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Nashville, Tennessee, Förenta staterna, 37203
- The Children's Hospital at TriStar Centennial
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Texas
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Austin, Texas, Förenta staterna, 78723
- Dell Children's Medical Center of Central Texas
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Corpus Christi, Texas, Förenta staterna, 78411
- Driscoll Children's Hospital
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Dallas, Texas, Förenta staterna, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
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Dallas, Texas, Förenta staterna, 75230
- Medical City Dallas Hospital
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El Paso, Texas, Förenta staterna, 79905
- El Paso Children's Hospital
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Fort Worth, Texas, Förenta staterna, 76104
- Cook Children's Medical Center
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Houston, Texas, Förenta staterna, 77030
- UT MD Anderson Cancer Center
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Houston, Texas, Förenta staterna, 77030
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
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Lubbock, Texas, Förenta staterna, 79410
- Covenant Children's Hospital
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Lubbock, Texas, Förenta staterna, 79415
- UMC Cancer Center / UMC Health System
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San Antonio, Texas, Förenta staterna, 78207
- Children's Hospital of San Antonio
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San Antonio, Texas, Förenta staterna, 78229
- Methodist Children's Hospital of South Texas
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Temple, Texas, Förenta staterna, 76508
- Scott and White Memorial Hospital
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Utah
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Salt Lake City, Utah, Förenta staterna, 84113
- Primary Children's Hospital
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Vermont
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Burlington, Vermont, Förenta staterna, 05405
- University of Vermont and State Agricultural College
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Virginia
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Falls Church, Virginia, Förenta staterna, 22042
- Inova Fairfax Hospital
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Norfolk, Virginia, Förenta staterna, 23507
- Children's Hospital of The King's Daughters
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Portsmouth, Virginia, Förenta staterna, 23708-2197
- Naval Medical Center - Portsmouth
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Richmond, Virginia, Förenta staterna, 23298
- VCU Massey Comprehensive Cancer Center
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Washington
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Seattle, Washington, Förenta staterna, 98105
- Seattle Children's Hospital
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Spokane, Washington, Förenta staterna, 99204
- Providence Sacred Heart Medical Center and Children's Hospital
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Tacoma, Washington, Förenta staterna, 98405
- Mary Bridge Children's Hospital and Health Center
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Tacoma, Washington, Förenta staterna, 98431
- Madigan Army Medical Center
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West Virginia
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Morgantown, West Virginia, Förenta staterna, 26506
- West Virginia University Healthcare
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Wisconsin
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Madison, Wisconsin, Förenta staterna, 53792
- University of Wisconsin Carbone Cancer Center - University Hospital
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Marshfield, Wisconsin, Förenta staterna, 54449
- Marshfield Medical Center-Marshfield
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Milwaukee, Wisconsin, Förenta staterna, 53226
- Children's Hospital of Wisconsin
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San Juan, Puerto Rico, 00926
- University Pediatric Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
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Patient must have enrolled onto APEC1621SC (NCT03155620) and must have been given a treatment assignment to MATCH to APEC1621M based on the presence of an actionable mutation as defined in APEC1621SC
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Patients must be >=12 months and =< 21 years of age at the time of study enrollment
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Patients must have a body surface area >= 0.29 m^2 at enrollment
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Patients must have radiographically measurable disease at the time of study enrollment. Patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG) positive (+) evaluable disease are eligible. Measurable disease in patients with CNS involvement is defined as any lesion that is at minimum 10 mm in one dimension on standard magnetic resonance imaging (MRI) or computed tomography (CT)
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Note: The following do not qualify as measurable disease:
- Malignant fluid collections (e.g., ascites, pleural effusions)
- Bone marrow infiltration except that detected by MIBG scan for neuroblastoma
- Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma
- Elevated tumor markers in plasma or cerebral spinal fluid (CSF)
- Previously radiated lesions that have not demonstrated clear progression post radiation
- Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
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Karnofsky >= 50 for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age. Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
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Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately
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Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive
- >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
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Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent
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Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1
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Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
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Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor. For growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair and the study-assigned research coordinator
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Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
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Stem cell infusions (with or without total body irradiation [TBI]):
- Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)
- Autologous stem cell infusion including boost infusion: >= 42 days
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Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)
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Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation
- Note: Radiation may not be delivered to "measurable disease" tumor site(s) being used to follow response to subprotocol treatment
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Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radio-pharmaceutical therapy
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Patients must not have received prior exposure to tipifarnib
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For patients with solid tumors without known bone marrow involvement (within 7 days prior to enrollment):
- Peripheral absolute neutrophil count (ANC) >= 1000/mm^3
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For patients with solid tumors without known bone marrow involvement (within 7 days prior to enrollment):
- Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
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Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity
-
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 (within 7 days prior to enrollment) or
-
A serum creatinine based on age/gender as follows (within 7 days prior to enrollment):
-
Age: Maximum serum creatinine (mg/dL)
- 1 to < 2 years: male (0.6), female (0.6)
- 2 to < 6 years: male (0.8), female (0.8)
- 6 to < 10 years: male (1), female (1)
- 10 to < 13 years: male (1.2), female (1.2)
- 13 to < 16 years: male (1.5), female (1.4)
- >= 16 years: male (1.7), female (1.4)
-
-
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
-
Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L. (For the purpose of this study, the ULN for SGPT is 45 U/L.) (within 7 days prior to enrollment)
-
Serum albumin >= 2 g/dL (within 7 days prior to enrollment)
-
Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
-
Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5.0) resulting from prior therapy must be =< grade 2
-
Patients must be able to swallow intact tablets or crushed tablets mixed in water, orange juice, apple juice, tomato juice, ginger ale, applesauce, yogurt, protein shake, or a dietary supplement drink (such as Ensure). Percutaneous endoscopic gastrostomy (PEG)-tube or nasogastric tube administration is permitted
-
All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines
Exclusion Criteria:
- Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective contraceptive methods for the duration of study treatment. Both female subjects and male subjects with female partners of child-bearing potential must agree to use a highly effective method of contraception for 2 weeks prior to protocol therapy, during, and at least 4 weeks after last dose of tipifarnib. In addition, since tipifarnib could induce toxicity of male reproductive organs and cause impairment of fertility, sperm cryopreservation should be recommended for male subjects wishing to preserve their fertility following tipifarnib treatment
- Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
- Patients who are currently receiving another investigational drug are not eligible
- Patients who are currently receiving other anti-cancer agents are not eligible
- Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial
- Patients who are currently receiving drugs that are strong inducers or inhibitors of CYP3A4/5 or UGT are not eligible. Strong inducers or inhibitors of CYP3A4/5 or UGT should be avoided from 14 days prior to the 1st dose of tipifarnib to the end of the study. In addition, patients receiving agents that are sensitive or narrow therapeutic range substrates of CYP3A4/5 are not eligible. Note: CYP3A4/5 inducing anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed
- Patients with known hypersensitivity to tipifarnib or any components of the tablet are not eligible
- Patients with hypersensitivity to imidazoles, such as clotrimazole, ketoconazole, miconazole and others in this drug class are not eligible
- Patients who have an uncontrolled infection are not eligible
- Patients who have received a prior solid organ transplantation are not eligible
- Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Treatment (tipifarnib)
Patients receive tipifarnib tablets 350 mg/m^2/dose PO or via nasogastric or gastric tube BID (maximum 600 mg/dose BID) with food on days 1-7 and 15-21. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. |
Tipifarnib tablets
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Objective Response Rate (Complete Response + Partial Response) in Pediatric Patients Treated With Tipifarnib
Tidsram: Up to 2 years from study entry
|
A responder is defined as a patient who achieves a best response of partial response or complete response on the study. Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method. The revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to determine response and progression in this study, with specific criteria outlined for the different subtypes of tumors (e.g., 2-dimensional measurements for central nervous system (CNS) tumors. |
Up to 2 years from study entry
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Patients Experiencing Grade 3 or Higher Adverse Events
Tidsram: Up to 2 years from study entry
|
Percentage of patients experiencing grade 3 or higher adverse events will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 |
Up to 2 years from study entry
|
|
Progression Free Survival (PFS)
Tidsram: Up to 6 months from study entry
|
The Kaplan-Meier method will be used to estimate the 6-month PFS. PFS is defined as time from initiation of protocol treatment to disease progression, recurrence, death from any cause, or date of last contact |
Up to 6 months from study entry
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Biomarker Analysis
Tidsram: Up to 7 years
|
Will evaluate other biomarkers as predictors of response to tipifarnib and whether tumors that harbor different missense mutations or fusions will demonstrate differential response to treatment. |
Up to 7 years
|
|
Profiling Changes in Tumor Genomics
Tidsram: Baseline, prior to cycle 5, end of treatment, assessed up to 7 years
|
Will explore approaches to the profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid. |
Baseline, prior to cycle 5, end of treatment, assessed up to 7 years
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Christine A Pratilas, Children's Oncology Group
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Sjukdomar i det endokrina systemet
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Neoplasmer
- Manliga urogenitala sjukdomar
- Njursjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Genetiska sjukdomar, medfödda
- Immunsystemets sjukdomar
- Luftvägssjukdomar
- Neoplasmer efter histologisk typ
- Lungsjukdomar
- Neoplasmer i endokrina körtel
- Neoplasmer i huvud och hals
- Neoplasmer, körtel och epitel
- Hudsjukdomar
- Lymfatiska sjukdomar
- Lymfoproliferativa störningar
- Immunproliferativa störningar
- Urologiska neoplasmer
- Neoplasmer, neuroepitelial
- Neuroektodermala tumörer
- Neoplasmer, könsceller och embryonala
- Neoplasmer, nervvävnad
- Lymfom
- Lungsjukdomar, interstitiell
- Neoplasmer i njurarna
- Neoplastiska syndrom, ärftligt
- Paragangliom
- Neuroendokrina tumörer
- Neoplasmer, bindväv och mjukvävnad
- Neuroektodermala tumörer, primitiva
- Neoplasmer, benvävnad
- Neoplasmer, bindväv
- Nevi och melanom
- Neoplasmer i huden
- Neoplasmer, muskelvävnad
- Neoplasmer, komplexa och blandade
- Myosarkom
- Sköldkörtelsjukdomar
- Histiocytos
- Medfödda, ärftliga och neonatala sjukdomar och abnormiteter
- Hud- och bindvävssjukdomar
- Hemiska och lymfsjukdomar
- Gliom
- Feokromocytom
- Neuroblastom
- Sarkom, Ewing
- Lymfom, icke-Hodgkin
- Melanom
- Sarkom
- Rabdomyosarkom
- Neuroektodermala tumörer, primitiva, perifera
- Osteosarkom
- Ependymom
- Medulloblastom
- Wilms tumör
- Rhabdoid tumör
- Hepatoblastom
- Histiocytos, Langerhans-Cell
- Sköldkörtelneoplasmer
- tipifarnib
Andra studie-ID-nummer
- NCI-2020-01015
- U10CA180886 (U.S.S. NIH-anslag/kontrakt)
- NCI-2020-01015 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- APEC1621M (Annan identifierare: CTEP)
- APEC1621M (Annan identifierare: Children's Oncology Group)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Läkemedels- och apparatinformation, studiedokument
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