Tipifarnib pour le traitement des tumeurs solides avancées, des lymphomes ou des troubles histiocytaires avec altérations du gène HRAS, un essai de traitement pédiatrique MATCH
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Sous-protocole de phase 2 du tipifarnib chez les patients atteints de tumeurs porteuses d'altérations génomiques HRAS
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.
Aperçu de l'étude
Statut
Les conditions
- Tumeur solide maligne
- Mélanome récurrent
- Épendymome récurrent
- Sarcome d'Ewing récurrent
- Hépatoblastome récurrent
- Histiocytose récurrente à cellules de Langerhans
- Tumeur germinale maligne récurrente
- Gliome malin récurrent
- Médulloblastome récurrent
- Neuroblastome récurrent
- Lymphome non hodgkinien récurrent
- Ostéosarcome récurrent
- Tumeur neuroectodermique primitive périphérique récurrente
- Tumeur rhabdoïde récurrente
- Rhabdomyosarcome récurrent
- Sarcome récurrent des tissus mous
- Gliome récurrent de grade 2 de l'OMS
- Épendymome réfractaire
- Sarcome d'Ewing réfractaire
- Hépatoblastome réfractaire
- Histiocytose à cellules de Langerhans réfractaire
- Tumeur germinale maligne réfractaire
- Gliome malin réfractaire
- Médulloblastome réfractaire
- Neuroblastome réfractaire
- Lymphome non hodgkinien réfractaire
- Ostéosarcome réfractaire
- Tumeur neuroectodermique primitive périphérique réfractaire
- Tumeur rhabdoïde réfractaire
- Rhabdomyosarcome réfractaire
- Sarcome des tissus mous réfractaire
- Gliome réfractaire de grade 2 de l'OMS
- Carcinome récidivant de la glande thyroïde
- Mélanome réfractaire
- Phéochromocytome récurrent de la glande surrénale
- Ectomesenchymome récurrent
- Tumeur de Wilms récurrente du rein
- Tumeur rhabdoïde récurrente du rein
- Phéochromocytome réfractaire de la glande surrénale
- Tumeur rhabdoïde réfractaire du rein
- Carcinome réfractaire de la glande thyroïde
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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San Juan, Porto Rico, 00926
- University Pediatric Hospital
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Alabama
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Birmingham, Alabama, États-Unis, 35233
- Children's Hospital of Alabama
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Alaska
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Anchorage, Alaska, États-Unis, 99508
- Providence Alaska Medical Center
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Arizona
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Mesa, Arizona, États-Unis, 85202
- Banner Children's at Desert
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Phoenix, Arizona, États-Unis, 85016
- Phoenix Childrens Hospital
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Tucson, Arizona, États-Unis, 85719
- Banner University Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, États-Unis, 72202-3591
- Arkansas Children's Hospital
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California
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Downey, California, États-Unis, 90242
- Kaiser Permanente Downey Medical Center
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Duarte, California, États-Unis, 91010
- City of Hope Comprehensive Cancer Center
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Loma Linda, California, États-Unis, 92354
- Loma Linda University Medical Center
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Long Beach, California, États-Unis, 90806
- Miller Children's and Women's Hospital Long Beach
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Los Angeles, California, États-Unis, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, États-Unis, 90027
- Children's Hospital Los Angeles
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Los Angeles, California, États-Unis, 90095
- Mattel Children's Hospital UCLA
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Madera, California, États-Unis, 93636
- Valley Children's Hospital
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Oakland, California, États-Unis, 94609
- UCSF Benioff Children's Hospital Oakland
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Oakland, California, États-Unis, 94611
- Kaiser Permanente-Oakland
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Orange, California, États-Unis, 92868
- Children's Hospital of Orange County
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Palo Alto, California, États-Unis, 94304
- Lucile Packard Children's Hospital Stanford University
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Sacramento, California, États-Unis, 95817
- University of California Davis Comprehensive Cancer Center
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San Diego, California, États-Unis, 92123
- Rady Children's Hospital - San Diego
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San Diego, California, États-Unis, 92134
- Naval Medical Center -San Diego
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San Francisco, California, États-Unis, 94158
- UCSF Medical Center-Mission Bay
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Torrance, California, États-Unis, 90502
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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Colorado
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Aurora, Colorado, États-Unis, 80045
- Children's Hospital Colorado
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Denver, Colorado, États-Unis, 80218
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
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Connecticut
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Hartford, Connecticut, États-Unis, 06106
- Connecticut Children's Medical Center
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New Haven, Connecticut, États-Unis, 06520
- Yale University
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Delaware
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Wilmington, Delaware, États-Unis, 19803
- Alfred I duPont Hospital for Children
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District of Columbia
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Washington D.C., District of Columbia, États-Unis, 20010
- Children's National Medical Center
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Washington D.C., District of Columbia, États-Unis, 20007
- MedStar Georgetown University Hospital
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Florida
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Fort Lauderdale, Florida, États-Unis, 33316
- Broward Health Medical Center
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Fort Myers, Florida, États-Unis, 33908
- Golisano Children's Hospital of Southwest Florida
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Gainesville, Florida, États-Unis, 32610
- UF Health Cancer Institute - Gainesville
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Hollywood, Florida, États-Unis, 33021
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
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Jacksonville, Florida, États-Unis, 32207
- Nemours Children's Clinic-Jacksonville
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Miami, Florida, États-Unis, 33155
- Nicklaus Children's Hospital
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Miami, Florida, États-Unis, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Miami, Florida, États-Unis, 33176
- Miami Cancer Institute
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Orlando, Florida, États-Unis, 32827
- Nemours Children's Hospital
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Orlando, Florida, États-Unis, 32803
- AdventHealth Orlando
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Orlando, Florida, États-Unis, 32806
- Arnold Palmer Hospital for Children
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Pensacola, Florida, États-Unis, 32504
- Sacred Heart Hospital
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St. Petersburg, Florida, États-Unis, 33701
- Johns Hopkins All Children's Hospital
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Tampa, Florida, États-Unis, 33606
- Tampa General Hospital
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Tampa, Florida, États-Unis, 33607
- Saint Joseph's Hospital/Children's Hospital-Tampa
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West Palm Beach, Florida, États-Unis, 33407
- Saint Mary's Medical Center
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Georgia
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Atlanta, Georgia, États-Unis, 30329
- Children's Healthcare of Atlanta - Arthur M Blank Hospital
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Savannah, Georgia, États-Unis, 31404
- Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, États-Unis, 96826
- Kapiolani Medical Center for Women and Children
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Idaho
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Boise, Idaho, États-Unis, 83712
- Saint Luke's Cancer Institute - Boise
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Illinois
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Chicago, Illinois, États-Unis, 60637
- University of Chicago Comprehensive Cancer Center
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Chicago, Illinois, États-Unis, 60612
- University of Illinois
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Chicago, Illinois, États-Unis, 60611
- Lurie Children's Hospital-Chicago
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Maywood, Illinois, États-Unis, 60153
- Loyola University Medical Center
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Peoria, Illinois, États-Unis, 61637
- OSF Children's Hospital of Illinois
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Springfield, Illinois, États-Unis, 62702
- Southern Illinois University School of Medicine
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Indiana
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Indianapolis, Indiana, États-Unis, 46202
- Riley Hospital for Children
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Indianapolis, Indiana, États-Unis, 46260
- Ascension Saint Vincent Indianapolis Hospital
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Iowa
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Des Moines, Iowa, États-Unis, 50309
- Blank Children's Hospital
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Iowa City, Iowa, États-Unis, 52242
- University of Iowa/Holden Comprehensive Cancer Center
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Kentucky
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Lexington, Kentucky, États-Unis, 40536
- University of Kentucky/Markey Cancer Center
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Louisville, Kentucky, États-Unis, 40202
- Norton Children's Hospital
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Louisiana
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New Orleans, Louisiana, États-Unis, 70121
- Ochsner Medical Center Jefferson
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New Orleans, Louisiana, États-Unis, 70118
- Children's Hospital New Orleans
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Maine
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Bangor, Maine, États-Unis, 04401
- Eastern Maine Medical Center
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Scarborough, Maine, États-Unis, 04074
- Maine Children's Cancer Program
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Maryland
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Baltimore, Maryland, États-Unis, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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Baltimore, Maryland, États-Unis, 21215
- Sinai Hospital of Baltimore
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Baltimore, Maryland, États-Unis, 21201
- University of Maryland/Greenebaum Cancer Center
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Bethesda, Maryland, États-Unis, 20892
- National Institutes of Health Clinical Center
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Massachusetts
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Boston, Massachusetts, États-Unis, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, États-Unis, 02114
- Massachusetts General Hospital Cancer Center
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Worcester, Massachusetts, États-Unis, 01655
- UMass Memorial Medical Center - University Campus
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- C S Mott Children's Hospital
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Detroit, Michigan, États-Unis, 48201
- Children's Hospital of Michigan
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Detroit, Michigan, États-Unis, 48201
- Wayne State University/Karmanos Cancer Institute
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East Lansing, Michigan, États-Unis, 48823
- Michigan State University
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Grand Rapids, Michigan, États-Unis, 49503
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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Kalamazoo, Michigan, États-Unis, 49007
- Bronson Methodist Hospital
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Royal Oak, Michigan, États-Unis, 48073
- Corewell Health Children's
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Minneapolis, Minnesota, États-Unis, 55455
- University of Minnesota/Masonic Cancer Center
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Mississippi
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Jackson, Mississippi, États-Unis, 39216
- University of Mississippi Medical Center
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Missouri
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Kansas City, Missouri, États-Unis, 64108
- Children's Mercy Hospitals and Clinics
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St Louis, Missouri, États-Unis, 63110
- Washington University School of Medicine
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St Louis, Missouri, États-Unis, 63141
- Mercy Hospital Saint Louis
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St Louis, Missouri, États-Unis, 63104
- Cardinal Glennon Children's Medical Center
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Nebraska
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Omaha, Nebraska, États-Unis, 68198
- University of Nebraska Medical Center
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Omaha, Nebraska, États-Unis, 68114
- Children's Hospital and Medical Center of Omaha
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Nevada
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Las Vegas, Nevada, États-Unis, 89144
- Summerlin Hospital Medical Center
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Las Vegas, Nevada, États-Unis, 89109
- Sunrise Hospital and Medical Center
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Las Vegas, Nevada, États-Unis, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Las Vegas, Nevada, États-Unis, 89102
- University Medical Center of Southern Nevada
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Reno, Nevada, États-Unis, 89502
- Renown Regional Medical Center
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New Hampshire
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Lebanon, New Hampshire, États-Unis, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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New Jersey
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Hackensack, New Jersey, États-Unis, 07601
- Hackensack University Medical Center
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Morristown, New Jersey, États-Unis, 07960
- Morristown Medical Center
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New Brunswick, New Jersey, États-Unis, 08901
- Saint Peter's University Hospital
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New Brunswick, New Jersey, États-Unis, 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, États-Unis, 12208
- Albany Medical Center
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Buffalo, New York, États-Unis, 14263
- Roswell Park Cancer Institute
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Mineola, New York, États-Unis, 11501
- NYU Langone Hospital - Long Island
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New Hyde Park, New York, États-Unis, 11040
- The Steven and Alexandra Cohen Children's Medical Center of New York
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New York, New York, États-Unis, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, États-Unis, 10032
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
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New York, New York, États-Unis, 10065
- NYP/Weill Cornell Medical Center
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New York, New York, États-Unis, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
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Rochester, New York, États-Unis, 14642
- University of Rochester
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Stony Brook, New York, États-Unis, 11794
- Stony Brook University Medical Center
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Syracuse, New York, États-Unis, 13210
- State University of New York Upstate Medical University
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The Bronx, New York, États-Unis, 10467
- Montefiore Medical Center - Moses Campus
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Valhalla, New York, États-Unis, 10595
- New York Medical College
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North Carolina
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Asheville, North Carolina, États-Unis, 28801
- Mission Hospital
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Chapel Hill, North Carolina, États-Unis, 27599
- UNC Lineberger Comprehensive Cancer Center
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Charlotte, North Carolina, États-Unis, 28203
- Carolinas Medical Center/Levine Cancer Institute
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Charlotte, North Carolina, États-Unis, 28204
- Novant Health Presbyterian Medical Center
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Durham, North Carolina, États-Unis, 27710
- Duke University Medical Center
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Greenville, North Carolina, États-Unis, 27834
- East Carolina University
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Winston-Salem, North Carolina, États-Unis, 27157
- Wake Forest University Health Sciences
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North Dakota
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Fargo, North Dakota, États-Unis, 58122
- Sanford Broadway Medical Center
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Ohio
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Akron, Ohio, États-Unis, 44308
- Children's Hospital Medical Center of Akron
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Cincinnati, Ohio, États-Unis, 45229
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, États-Unis, 44195
- Cleveland Clinic Foundation
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Cleveland, Ohio, États-Unis, 44106
- Rainbow Babies and Childrens Hospital
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Columbus, Ohio, États-Unis, 43205
- Nationwide Children's Hospital
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Dayton, Ohio, États-Unis, 45404
- Dayton Children's Hospital
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Toledo, Ohio, États-Unis, 43606
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73104
- University of Oklahoma Health Sciences Center
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Oregon
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Portland, Oregon, États-Unis, 97239
- Oregon Health and Science University
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Portland, Oregon, États-Unis, 97227
- Legacy Emanuel Children's Hospital
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Pennsylvania
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Allentown, Pennsylvania, États-Unis, 18103
- Lehigh Valley Hospital-Cedar Crest
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Danville, Pennsylvania, États-Unis, 17822
- Geisinger Medical Center
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Philadelphia, Pennsylvania, États-Unis, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, États-Unis, 19134
- Saint Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, États-Unis, 15224
- Children's Hospital of Pittsburgh of UPMC
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Rhode Island
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Providence, Rhode Island, États-Unis, 02903
- Rhode Island Hospital
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South Carolina
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Columbia, South Carolina, États-Unis, 29203
- Prisma Health Richland Hospital
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Greenville, South Carolina, États-Unis, 29605
- BI-LO Charities Children's Cancer Center
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South Dakota
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Sioux Falls, South Dakota, États-Unis, 57117-5134
- Sanford USD Medical Center - Sioux Falls
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Tennessee
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Chattanooga, Tennessee, États-Unis, 37403
- T C Thompson Children's Hospital
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Knoxville, Tennessee, États-Unis, 37916
- East Tennessee Childrens Hospital
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Memphis, Tennessee, États-Unis, 38105
- Saint Jude Children's Research Hospital
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Nashville, Tennessee, États-Unis, 37232
- Vanderbilt University/Ingram Cancer Center
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Nashville, Tennessee, États-Unis, 37203
- The Children's Hospital at TriStar Centennial
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Texas
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Austin, Texas, États-Unis, 78723
- Dell Children's Medical Center of Central Texas
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Corpus Christi, Texas, États-Unis, 78411
- Driscoll Children's Hospital
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Dallas, Texas, États-Unis, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
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Dallas, Texas, États-Unis, 75230
- Medical City Dallas Hospital
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El Paso, Texas, États-Unis, 79905
- El Paso Children's Hospital
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Fort Worth, Texas, États-Unis, 76104
- Cook Children's Medical Center
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Houston, Texas, États-Unis, 77030
- UT MD Anderson Cancer Center
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Houston, Texas, États-Unis, 77030
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
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Lubbock, Texas, États-Unis, 79410
- Covenant Children's Hospital
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Lubbock, Texas, États-Unis, 79415
- UMC Cancer Center / UMC Health System
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San Antonio, Texas, États-Unis, 78207
- Children's Hospital of San Antonio
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San Antonio, Texas, États-Unis, 78229
- Methodist Children's Hospital of South Texas
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Temple, Texas, États-Unis, 76508
- Scott and White Memorial Hospital
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Utah
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Salt Lake City, Utah, États-Unis, 84113
- Primary Children's Hospital
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Vermont
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Burlington, Vermont, États-Unis, 05405
- University of Vermont and State Agricultural College
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Virginia
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Falls Church, Virginia, États-Unis, 22042
- Inova Fairfax Hospital
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Norfolk, Virginia, États-Unis, 23507
- Children's Hospital of The King's Daughters
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Portsmouth, Virginia, États-Unis, 23708-2197
- Naval Medical Center - Portsmouth
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Richmond, Virginia, États-Unis, 23298
- VCU Massey Comprehensive Cancer Center
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Washington
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Seattle, Washington, États-Unis, 98105
- Seattle Children's Hospital
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Spokane, Washington, États-Unis, 99204
- Providence Sacred Heart Medical Center and Children's Hospital
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Tacoma, Washington, États-Unis, 98405
- Mary Bridge Children's Hospital and Health Center
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Tacoma, Washington, États-Unis, 98431
- Madigan Army Medical Center
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West Virginia
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Morgantown, West Virginia, États-Unis, 26506
- West Virginia University Healthcare
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Wisconsin
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Madison, Wisconsin, États-Unis, 53792
- University of Wisconsin Carbone Cancer Center - University Hospital
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Marshfield, Wisconsin, États-Unis, 54449
- Marshfield Medical Center-Marshfield
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Milwaukee, Wisconsin, États-Unis, 53226
- Children's Hospital of Wisconsin
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
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Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 (within 7 days prior to enrollment) or
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A serum creatinine based on age/gender as follows (within 7 days prior to enrollment):
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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)
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Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
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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)
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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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Objective Response Rate (Complete Response + Partial Response) in Pediatric Patients Treated With Tipifarnib
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Patients Experiencing Grade 3 or Higher Adverse Events
Délai: 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)
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Biomarker Analysis
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Christine A Pratilas, Children's Oncology Group
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies du système endocrinien
- Tumeurs urogénitales
- Tumeurs par site
- Tumeurs
- Maladies urogénitales masculines
- Maladies rénales
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Maladies génétiques, innées
- Maladies du système immunitaire
- Maladies des voies respiratoires
- Tumeurs par type histologique
- Maladies pulmonaires
- Tumeurs des glandes endocrines
- Tumeurs de la tête et du cou
- Tumeurs, glandulaires et épithéliales
- Maladies de la peau
- Maladies lymphatiques
- Troubles lymphoprolifératifs
- Troubles immunoprolifératifs
- Tumeurs urologiques
- Tumeurs, neuroépithéliales
- Tumeurs neuroectodermiques
- Tumeurs, cellules germinales et embryonnaires
- Tumeurs, tissu nerveux
- Lymphome
- Maladies pulmonaires interstitielles
- Tumeurs rénales
- Syndromes néoplasiques, héréditaires
- Paragangliome
- Tumeurs neuroendocrines
- Tumeurs, tissus conjonctifs et mous
- Tumeurs neuroectodermiques primitives
- Tumeurs, tissu osseux
- Tumeurs, tissu conjonctif
- Nevi et mélanomes
- Tumeurs cutanées
- Tumeurs, tissus musculaires
- Tumeurs, complexes et mixtes
- Myosarcome
- Maladies thyroïdiennes
- Histiocytose
- Maladies et anomalies congénitales, héréditaires et néonatales
- Maladies de la peau et du tissu conjonctif
- Maladies hémiques et lymphatiques
- Gliome
- Phéochromocytome
- Neuroblastome
- Sarcome d'Ewing
- Lymphome non hodgkinien
- Mélanome
- Sarcome
- Rhabdomyosarcome
- Tumeurs neuroectodermiques, primitives, périphériques
- Ostéosarcome
- Épendymome
- Médulloblastome
- Tumeur de Wilms
- Tumeur rhabdoïde
- Hépatoblastome
- Histiocytose, cellule de Langerhans
- Tumeurs thyroïdiennes
- tipifarnib
Autres numéros d'identification d'étude
- NCI-2020-01015
- U10CA180886 (Subvention/contrat des NIH des États-Unis)
- NCI-2020-01015 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
- APEC1621M (Autre identifiant: CTEP)
- APEC1621M (Autre identifiant: Children's Oncology Group)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
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