Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Tipifarnib w leczeniu zaawansowanych guzów litych, chłoniaków lub zaburzeń histiocytarnych ze zmianami genu HRAS, badanie kliniczne MATCH u dzieci

10 listopada 2026 zaktualizowane przez: National Cancer Institute (NCI)

NCI-COG Pediatric MATCH (analiza molekularna w celu wyboru terapii) — podprotokół fazy 2 dotyczący stosowania tipifarnibu u pacjentów z nowotworami zawierającymi zmiany genomowe 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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Lek: Tipifarnib

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

Faza

Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Portoryko
- - San Juan, Portoryko, 00926
    - University Pediatric Hospital
Stany Zjednoczone
- Alabama
  - Birmingham, Alabama, Stany Zjednoczone, 35233
    - Children's Hospital of Alabama
- Alaska
  - Anchorage, Alaska, Stany Zjednoczone, 99508
    - Providence Alaska Medical Center
- Arizona
  - Mesa, Arizona, Stany Zjednoczone, 85202
    - Banner Children's at Desert
  - Phoenix, Arizona, Stany Zjednoczone, 85016
    - Phoenix Childrens Hospital
  - Tucson, Arizona, Stany Zjednoczone, 85719
    - Banner University Medical Center - Tucson
- Arkansas
  - Little Rock, Arkansas, Stany Zjednoczone, 72202-3591
    - Arkansas Children's Hospital
- California
  - Downey, California, Stany Zjednoczone, 90242
    - Kaiser Permanente Downey Medical Center
  - Duarte, California, Stany Zjednoczone, 91010
    - City of Hope Comprehensive Cancer Center
  - Loma Linda, California, Stany Zjednoczone, 92354
    - Loma Linda University Medical Center
  - Long Beach, California, Stany Zjednoczone, 90806
    - Miller Children's and Women's Hospital Long Beach
  - Los Angeles, California, Stany Zjednoczone, 90048
    - Cedars-Sinai Medical Center
  - Los Angeles, California, Stany Zjednoczone, 90027
    - Children's Hospital Los Angeles
  - Los Angeles, California, Stany Zjednoczone, 90095
    - Mattel Children's Hospital UCLA
  - Madera, California, Stany Zjednoczone, 93636
    - Valley Children's Hospital
  - Oakland, California, Stany Zjednoczone, 94609
    - UCSF Benioff Children's Hospital Oakland
  - Oakland, California, Stany Zjednoczone, 94611
    - Kaiser Permanente-Oakland
  - Orange, California, Stany Zjednoczone, 92868
    - Children's Hospital of Orange County
  - Palo Alto, California, Stany Zjednoczone, 94304
    - Lucile Packard Children's Hospital Stanford University
  - Sacramento, California, Stany Zjednoczone, 95817
    - University of California Davis Comprehensive Cancer Center
  - San Diego, California, Stany Zjednoczone, 92123
    - Rady Children's Hospital - San Diego
  - San Diego, California, Stany Zjednoczone, 92134
    - Naval Medical Center -San Diego
  - San Francisco, California, Stany Zjednoczone, 94158
    - UCSF Medical Center-Mission Bay
  - Torrance, California, Stany Zjednoczone, 90502
    - Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Colorado
  - Aurora, Colorado, Stany Zjednoczone, 80045
    - Children's Hospital Colorado
  - Denver, Colorado, Stany Zjednoczone, 80218
    - Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
- Connecticut
  - Hartford, Connecticut, Stany Zjednoczone, 06106
    - Connecticut Children's Medical Center
  - New Haven, Connecticut, Stany Zjednoczone, 06520
    - Yale University
- Delaware
  - Wilmington, Delaware, Stany Zjednoczone, 19803
    - Alfred I duPont Hospital for Children
- District of Columbia
  - Washington D.C., District of Columbia, Stany Zjednoczone, 20010
    - Children's National Medical Center
  - Washington D.C., District of Columbia, Stany Zjednoczone, 20007
    - MedStar Georgetown University Hospital
- Florida
  - Fort Lauderdale, Florida, Stany Zjednoczone, 33316
    - Broward Health Medical Center
  - Fort Myers, Florida, Stany Zjednoczone, 33908
    - Golisano Children's Hospital of Southwest Florida
  - Gainesville, Florida, Stany Zjednoczone, 32610
    - UF Health Cancer Institute - Gainesville
  - Hollywood, Florida, Stany Zjednoczone, 33021
    - Memorial Regional Hospital/Joe DiMaggio Children's Hospital
  - Jacksonville, Florida, Stany Zjednoczone, 32207
    - Nemours Children's Clinic-Jacksonville
  - Miami, Florida, Stany Zjednoczone, 33155
    - Nicklaus Children's Hospital
  - Miami, Florida, Stany Zjednoczone, 33136
    - University of Miami Miller School of Medicine-Sylvester Cancer Center
  - Miami, Florida, Stany Zjednoczone, 33176
    - Miami Cancer Institute
  - Orlando, Florida, Stany Zjednoczone, 32827
    - Nemours Children's Hospital
  - Orlando, Florida, Stany Zjednoczone, 32803
    - AdventHealth Orlando
  - Orlando, Florida, Stany Zjednoczone, 32806
    - Arnold Palmer Hospital for Children
  - Pensacola, Florida, Stany Zjednoczone, 32504
    - Sacred Heart Hospital
  - St. Petersburg, Florida, Stany Zjednoczone, 33701
    - Johns Hopkins All Children's Hospital
  - Tampa, Florida, Stany Zjednoczone, 33606
    - Tampa General Hospital
  - Tampa, Florida, Stany Zjednoczone, 33607
    - Saint Joseph's Hospital/Children's Hospital-Tampa
  - West Palm Beach, Florida, Stany Zjednoczone, 33407
    - Saint Mary's Medical Center
- Georgia
  - Atlanta, Georgia, Stany Zjednoczone, 30329
    - Children's Healthcare of Atlanta - Arthur M Blank Hospital
  - Savannah, Georgia, Stany Zjednoczone, 31404
    - Memorial Health University Medical Center
- Hawaii
  - Honolulu, Hawaii, Stany Zjednoczone, 96826
    - Kapiolani Medical Center for Women and Children
- Idaho
  - Boise, Idaho, Stany Zjednoczone, 83712
    - Saint Luke's Cancer Institute - Boise
- Illinois
  - Chicago, Illinois, Stany Zjednoczone, 60637
    - University of Chicago Comprehensive Cancer Center
  - Chicago, Illinois, Stany Zjednoczone, 60612
    - University of Illinois
  - Chicago, Illinois, Stany Zjednoczone, 60611
    - Lurie Children's Hospital-Chicago
  - Maywood, Illinois, Stany Zjednoczone, 60153
    - Loyola University Medical Center
  - Peoria, Illinois, Stany Zjednoczone, 61637
    - OSF Children's Hospital of Illinois
  - Springfield, Illinois, Stany Zjednoczone, 62702
    - Southern Illinois University School of Medicine
- Indiana
  - Indianapolis, Indiana, Stany Zjednoczone, 46202
    - Riley Hospital for Children
  - Indianapolis, Indiana, Stany Zjednoczone, 46260
    - Ascension Saint Vincent Indianapolis Hospital
- Iowa
  - Des Moines, Iowa, Stany Zjednoczone, 50309
    - Blank Children's Hospital
  - Iowa City, Iowa, Stany Zjednoczone, 52242
    - University of Iowa/Holden Comprehensive Cancer Center
- Kentucky
  - Lexington, Kentucky, Stany Zjednoczone, 40536
    - University of Kentucky/Markey Cancer Center
  - Louisville, Kentucky, Stany Zjednoczone, 40202
    - Norton Children's Hospital
- Louisiana
  - New Orleans, Louisiana, Stany Zjednoczone, 70121
    - Ochsner Medical Center Jefferson
  - New Orleans, Louisiana, Stany Zjednoczone, 70118
    - Children's Hospital New Orleans
- Maine
  - Bangor, Maine, Stany Zjednoczone, 04401
    - Eastern Maine Medical Center
  - Scarborough, Maine, Stany Zjednoczone, 04074
    - Maine Children's Cancer Program
- Maryland
  - Baltimore, Maryland, Stany Zjednoczone, 21287
    - Johns Hopkins University/Sidney Kimmel Cancer Center
  - Baltimore, Maryland, Stany Zjednoczone, 21215
    - Sinai Hospital of Baltimore
  - Baltimore, Maryland, Stany Zjednoczone, 21201
    - University of Maryland/Greenebaum Cancer Center
  - Bethesda, Maryland, Stany Zjednoczone, 20892
    - National Institutes of Health Clinical Center
- Massachusetts
  - Boston, Massachusetts, Stany Zjednoczone, 02215
    - Dana-Farber Cancer Institute
  - Boston, Massachusetts, Stany Zjednoczone, 02114
    - Massachusetts General Hospital Cancer Center
  - Worcester, Massachusetts, Stany Zjednoczone, 01655
    - UMass Memorial Medical Center - University Campus
- Michigan
  - Ann Arbor, Michigan, Stany Zjednoczone, 48109
    - C S Mott Children's Hospital
  - Detroit, Michigan, Stany Zjednoczone, 48201
    - Children's Hospital of Michigan
  - Detroit, Michigan, Stany Zjednoczone, 48201
    - Wayne State University/Karmanos Cancer Institute
  - East Lansing, Michigan, Stany Zjednoczone, 48823
    - Michigan State University
  - Grand Rapids, Michigan, Stany Zjednoczone, 49503
    - Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
  - Kalamazoo, Michigan, Stany Zjednoczone, 49007
    - Bronson Methodist Hospital
  - Royal Oak, Michigan, Stany Zjednoczone, 48073
    - Corewell Health Children's
- Minnesota
  - Minneapolis, Minnesota, Stany Zjednoczone, 55404
    - Children's Hospitals and Clinics of Minnesota - Minneapolis
  - Minneapolis, Minnesota, Stany Zjednoczone, 55455
    - University of Minnesota/Masonic Cancer Center
- Mississippi
  - Jackson, Mississippi, Stany Zjednoczone, 39216
    - University of Mississippi Medical Center
- Missouri
  - Kansas City, Missouri, Stany Zjednoczone, 64108
    - Children's Mercy Hospitals and Clinics
  - St Louis, Missouri, Stany Zjednoczone, 63110
    - Washington University School of Medicine
  - St Louis, Missouri, Stany Zjednoczone, 63141
    - Mercy Hospital Saint Louis
  - St Louis, Missouri, Stany Zjednoczone, 63104
    - Cardinal Glennon Children's Medical Center
- Nebraska
  - Omaha, Nebraska, Stany Zjednoczone, 68198
    - University of Nebraska Medical Center
  - Omaha, Nebraska, Stany Zjednoczone, 68114
    - Children's Hospital and Medical Center of Omaha
- Nevada
  - Las Vegas, Nevada, Stany Zjednoczone, 89144
    - Summerlin Hospital Medical Center
  - Las Vegas, Nevada, Stany Zjednoczone, 89109
    - Sunrise Hospital and Medical Center
  - Las Vegas, Nevada, Stany Zjednoczone, 89135
    - Alliance for Childhood Diseases/Cure 4 the Kids Foundation
  - Las Vegas, Nevada, Stany Zjednoczone, 89102
    - University Medical Center of Southern Nevada
  - Reno, Nevada, Stany Zjednoczone, 89502
    - Renown Regional Medical Center
- New Hampshire
  - Lebanon, New Hampshire, Stany Zjednoczone, 03756
    - Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- New Jersey
  - Hackensack, New Jersey, Stany Zjednoczone, 07601
    - Hackensack University Medical Center
  - Morristown, New Jersey, Stany Zjednoczone, 07960
    - Morristown Medical Center
  - New Brunswick, New Jersey, Stany Zjednoczone, 08901
    - Saint Peter's University Hospital
  - New Brunswick, New Jersey, Stany Zjednoczone, 08903
    - Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
- New York
  - Albany, New York, Stany Zjednoczone, 12208
    - Albany Medical Center
  - Buffalo, New York, Stany Zjednoczone, 14263
    - Roswell Park Cancer Institute
  - Mineola, New York, Stany Zjednoczone, 11501
    - NYU Langone Hospital - Long Island
  - New Hyde Park, New York, Stany Zjednoczone, 11040
    - The Steven and Alexandra Cohen Children's Medical Center of New York
  - New York, New York, Stany Zjednoczone, 10065
    - Memorial Sloan Kettering Cancer Center
  - New York, New York, Stany Zjednoczone, 10032
    - NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
  - New York, New York, Stany Zjednoczone, 10065
    - NYP/Weill Cornell Medical Center
  - New York, New York, Stany Zjednoczone, 10016
    - Laura and Isaac Perlmutter Cancer Center at NYU Langone
  - Rochester, New York, Stany Zjednoczone, 14642
    - University of Rochester
  - Stony Brook, New York, Stany Zjednoczone, 11794
    - Stony Brook University Medical Center
  - Syracuse, New York, Stany Zjednoczone, 13210
    - State University of New York Upstate Medical University
  - The Bronx, New York, Stany Zjednoczone, 10467
    - Montefiore Medical Center - Moses Campus
  - Valhalla, New York, Stany Zjednoczone, 10595
    - New York Medical College
- North Carolina
  - Asheville, North Carolina, Stany Zjednoczone, 28801
    - Mission Hospital
  - Chapel Hill, North Carolina, Stany Zjednoczone, 27599
    - UNC Lineberger Comprehensive Cancer Center
  - Charlotte, North Carolina, Stany Zjednoczone, 28203
    - Carolinas Medical Center/Levine Cancer Institute
  - Charlotte, North Carolina, Stany Zjednoczone, 28204
    - Novant Health Presbyterian Medical Center
  - Durham, North Carolina, Stany Zjednoczone, 27710
    - Duke University Medical Center
  - Greenville, North Carolina, Stany Zjednoczone, 27834
    - East Carolina University
  - Winston-Salem, North Carolina, Stany Zjednoczone, 27157
    - Wake Forest University Health Sciences
- North Dakota
  - Fargo, North Dakota, Stany Zjednoczone, 58122
    - Sanford Broadway Medical Center
- Ohio
  - Akron, Ohio, Stany Zjednoczone, 44308
    - Children's Hospital Medical Center of Akron
  - Cincinnati, Ohio, Stany Zjednoczone, 45229
    - Cincinnati Children's Hospital Medical Center
  - Cleveland, Ohio, Stany Zjednoczone, 44195
    - Cleveland Clinic Foundation
  - Cleveland, Ohio, Stany Zjednoczone, 44106
    - Rainbow Babies and Childrens Hospital
  - Columbus, Ohio, Stany Zjednoczone, 43205
    - Nationwide Children's Hospital
  - Dayton, Ohio, Stany Zjednoczone, 45404
    - Dayton Children's Hospital
  - Toledo, Ohio, Stany Zjednoczone, 43606
    - ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
- Oklahoma
  - Oklahoma City, Oklahoma, Stany Zjednoczone, 73104
    - University of Oklahoma Health Sciences Center
- Oregon
  - Portland, Oregon, Stany Zjednoczone, 97239
    - Oregon Health and Science University
  - Portland, Oregon, Stany Zjednoczone, 97227
    - Legacy Emanuel Children's Hospital
- Pennsylvania
  - Allentown, Pennsylvania, Stany Zjednoczone, 18103
    - Lehigh Valley Hospital-Cedar Crest
  - Danville, Pennsylvania, Stany Zjednoczone, 17822
    - Geisinger Medical Center
  - Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
    - Children's Hospital of Philadelphia
  - Philadelphia, Pennsylvania, Stany Zjednoczone, 19134
    - Saint Christopher's Hospital for Children
  - Pittsburgh, Pennsylvania, Stany Zjednoczone, 15224
    - Children's Hospital of Pittsburgh of UPMC
- Rhode Island
  - Providence, Rhode Island, Stany Zjednoczone, 02903
    - Rhode Island Hospital
- South Carolina
  - Columbia, South Carolina, Stany Zjednoczone, 29203
    - Prisma Health Richland Hospital
  - Greenville, South Carolina, Stany Zjednoczone, 29605
    - BI-LO Charities Children's Cancer Center
- South Dakota
  - Sioux Falls, South Dakota, Stany Zjednoczone, 57117-5134
    - Sanford USD Medical Center - Sioux Falls
- Tennessee
  - Chattanooga, Tennessee, Stany Zjednoczone, 37403
    - T C Thompson Children's Hospital
  - Knoxville, Tennessee, Stany Zjednoczone, 37916
    - East Tennessee Childrens Hospital
  - Memphis, Tennessee, Stany Zjednoczone, 38105
    - Saint Jude Children's Research Hospital
  - Nashville, Tennessee, Stany Zjednoczone, 37232
    - Vanderbilt University/Ingram Cancer Center
  - Nashville, Tennessee, Stany Zjednoczone, 37203
    - The Children's Hospital at TriStar Centennial
- Texas
  - Austin, Texas, Stany Zjednoczone, 78723
    - Dell Children's Medical Center of Central Texas
  - Corpus Christi, Texas, Stany Zjednoczone, 78411
    - Driscoll Children's Hospital
  - Dallas, Texas, Stany Zjednoczone, 75390
    - UT Southwestern/Simmons Cancer Center-Dallas
  - Dallas, Texas, Stany Zjednoczone, 75230
    - Medical City Dallas Hospital
  - El Paso, Texas, Stany Zjednoczone, 79905
    - El Paso Children's Hospital
  - Fort Worth, Texas, Stany Zjednoczone, 76104
    - Cook Children's Medical Center
  - Houston, Texas, Stany Zjednoczone, 77030
    - UT MD Anderson Cancer Center
  - Houston, Texas, Stany Zjednoczone, 77030
    - Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
  - Lubbock, Texas, Stany Zjednoczone, 79410
    - Covenant Children's Hospital
  - Lubbock, Texas, Stany Zjednoczone, 79415
    - UMC Cancer Center / UMC Health System
  - San Antonio, Texas, Stany Zjednoczone, 78207
    - Children's Hospital of San Antonio
  - San Antonio, Texas, Stany Zjednoczone, 78229
    - Methodist Children's Hospital of South Texas
  - Temple, Texas, Stany Zjednoczone, 76508
    - Scott and White Memorial Hospital
- Utah
  - Salt Lake City, Utah, Stany Zjednoczone, 84113
    - Primary Children's Hospital
- Vermont
  - Burlington, Vermont, Stany Zjednoczone, 05405
    - University of Vermont and State Agricultural College
- Virginia
  - Falls Church, Virginia, Stany Zjednoczone, 22042
    - Inova Fairfax Hospital
  - Norfolk, Virginia, Stany Zjednoczone, 23507
    - Children's Hospital of The King's Daughters
  - Portsmouth, Virginia, Stany Zjednoczone, 23708-2197
    - Naval Medical Center - Portsmouth
  - Richmond, Virginia, Stany Zjednoczone, 23298
    - VCU Massey Comprehensive Cancer Center
- Washington
  - Seattle, Washington, Stany Zjednoczone, 98105
    - Seattle Children's Hospital
  - Spokane, Washington, Stany Zjednoczone, 99204
    - Providence Sacred Heart Medical Center and Children's Hospital
  - Tacoma, Washington, Stany Zjednoczone, 98405
    - Mary Bridge Children's Hospital and Health Center
  - Tacoma, Washington, Stany Zjednoczone, 98431
    - Madigan Army Medical Center
- West Virginia
  - Morgantown, West Virginia, Stany Zjednoczone, 26506
    - West Virginia University Healthcare
- Wisconsin
  - Madison, Wisconsin, Stany Zjednoczone, 53792
    - University of Wisconsin Carbone Cancer Center - University Hospital
  - Marshfield, Wisconsin, Stany Zjednoczone, 54449
    - Marshfield Medical Center-Marshfield
  - Milwaukee, Wisconsin, Stany Zjednoczone, 53226
    - Children's Hospital of Wisconsin

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

1 rok do 21 lat (Dziecko, Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

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
Patients must be >=12 months and =< 21 years of age at the time of study enrollment
Patients must have a body surface area >= 0.29 m^2 at enrollment
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)
- 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
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
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
- 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)
- 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
- 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
- Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
- 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
- Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
- 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
- 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.)
- 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
- Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radio-pharmaceutical therapy
- Patients must not have received prior exposure to tipifarnib
For patients with solid tumors without known bone marrow involvement (within 7 days prior to enrollment):
- Peripheral absolute neutrophil count (ANC) >= 1000/mm^3
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)
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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Główny cel: Leczenie
Przydział: Nie dotyczy
Model interwencyjny: Zadanie dla jednej grupy
Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm Grupa uczestników / Arm Grupa lub podgrupa uczestników badania klinicznego, którzy zgodnie z protokołem badania otrzymują określoną interwencję/leczenie lub nie otrzymują żadnej interwencji.	Interwencja / Leczenie Interwencja / Leczenie Proces lub działanie będące przedmiotem badania klinicznego. Interwencje obejmują leki, urządzenia medyczne, procedury, szczepionki i inne produkty, które są w fazie badań lub są już dostępne. Interwencje mogą również obejmować podejścia nieinwazyjne, takie jak edukacja lub modyfikacja diety i ćwiczeń.
Eksperymentalny: 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.	Lek: Tipifarnib Tipifarnib tablets Inne nazwy: R115777 Zarnestra

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
Objective Response Rate (Complete Response + Partial Response) in Pediatric Patients Treated With Tipifarnib Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
Percentage of Patients Experiencing Grade 3 or Higher Adverse Events Ramy czasowe: 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) Ramy czasowe: 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

Inne miary wyników

Miara wyniku	Opis środka	Ramy czasowe
Biomarker Analysis Ramy czasowe: 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 Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

National Cancer Institute (NCI)

Śledczy

Główny śledczy: Christine A Pratilas, Children's Oncology Group

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Pratilas CA, Yohe ME, Williams PM, Reid JM, Piao J, Saguilig L, Patton DR, Coffey B, Alonzo TA, Thompson AM, Arwood N, Roy-Chowdhuri S, Ramirez NC, Berg SL, Fox E, Weigel BJ, Hawkins DS, Mooney MM, Takebe N, Tricoli JV, Janeway KA, Seibel NL, Parsons DW. A phase 2 study of tipifarnib in children and young adults with tumors harboring HRAS genomic alterations: NCI-COG Pediatric MATCH trial (APEC1621M). Oncologist. 2026 Oct 9:oyag401. doi: 10.1093/oncolo/oyag401. Online ahead of print.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

13 października 2020

Zakończenie podstawowe (Rzeczywisty)

31 marca 2024

Ukończenie studiów (Szacowany)

30 września 2027

Daty rejestracji na studia

Pierwszy przesłany

25 lutego 2020

Pierwszy przesłany, który spełnia kryteria kontroli jakości

25 lutego 2020

Pierwszy wysłany (Rzeczywisty)

26 lutego 2020

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 listopada 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

NCI-2020-01015
U10CA180886 (Grant/umowa NIH USA)
NCI-2020-01015 (Identyfikator rejestru: CTRP (Clinical Trial Reporting Program))
APEC1621M (Inny identyfikator: CTEP)
APEC1621M (Inny identyfikator: Children's Oncology Group)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Tipifarnib w leczeniu zaawansowanych guzów litych, chłoniaków lub zaburzeń histiocytarnych ze zmianami genu HRAS, badanie kliniczne MATCH u dzieci

NCI-COG Pediatric MATCH (analiza molekularna w celu wyboru terapii) — podprotokół fazy 2 dotyczący stosowania tipifarnibu u pacjentów z nowotworami zawierającymi zmiany genomowe HRAS

Przegląd badań

Status

Warunki

Interwencja / Leczenie

Szczegółowy opis

Typ studiów

Zapisy (Rzeczywisty)

Faza

Kontakty i lokalizacje

Lokalizacje studiów

Kryteria uczestnictwa

Kryteria kwalifikacji

Wiek uprawniający do nauki

Akceptuje zdrowych ochotników

Płeć kwalifikująca się do nauki

Opis

Plan studiów

Jak projektuje się badanie?

Szczegóły projektu

Liczba ramion

Broń i interwencje

Grupa uczestników / Arm

Interwencja / Leczenie

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku

Opis środka

Ramy czasowe

Miary wyników drugorzędnych

Miara wyniku

Opis środka

Ramy czasowe

Inne miary wyników

Miara wyniku

Opis środka

Ramy czasowe

Współpracownicy i badacze

Sponsor

Śledczy

Publikacje i pomocne linki

Publikacje ogólne

Daty zapisu na studia

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

Zakończenie podstawowe (Rzeczywisty)

Ukończenie studiów (Szacowany)

Daty rejestracji na studia

Pierwszy przesłany

Pierwszy przesłany, który spełnia kryteria kontroli jakości

Pierwszy wysłany (Rzeczywisty)

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

Ostatnia weryfikacja

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

Opis planu IPD

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Bada produkt urządzenia regulowany przez amerykańską FDA