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Tipifarnib til behandling af avancerede solide tumorer, lymfomer eller histiocytiske lidelser med HRAS-genændringer, et pædiatrisk MATCH-behandlingsforsøg

10. november 2026 opdateret af: National Cancer Institute (NCI)

NCI-COG Pediatric MATCH (molekylær analyse for valg af terapi) - Fase 2-underprotokol af Tipifarnib hos patienter med tumorer, der rummer HRAS-genomiske ændringer

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Medicin: Tipifarnib

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

Fase

Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 år til 21 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: N/A
Interventionel model: Enkelt gruppeopgave
Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm Deltagergruppe / Arm En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.	Intervention / Behandling Intervention / Behandling En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: 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.	Medicin: Tipifarnib Tipifarnib tablets Andre navne: R115777 Zarnestra

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Objective Response Rate (Complete Response + Partial Response) in Pediatric Patients Treated With Tipifarnib Tidsramme: 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

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Percentage of Patients Experiencing Grade 3 or Higher Adverse Events Tidsramme: 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) Tidsramme: 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

Andre resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Biomarker Analysis Tidsramme: 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 Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Cancer Institute (NCI)

Efterforskere

Ledende efterforsker: Christine A Pratilas, Children's Oncology Group

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

13. oktober 2020

Primær færdiggørelse (Faktiske)

31. marts 2024

Studieafslutning (Anslået)

30. september 2027

Datoer for studieregistrering

Først indsendt

25. februar 2020

Først indsendt, der opfyldte QC-kriterier

25. februar 2020

Først opslået (Faktiske)

26. februar 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. november 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

NCI-2020-01015
U10CA180886 (U.S. NIH-bevilling/kontrakt)
NCI-2020-01015 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
APEC1621M (Anden identifikator: CTEP)
APEC1621M (Anden identifikator: Children's Oncology Group)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Tipifarnib til behandling af avancerede solide tumorer, lymfomer eller histiocytiske lidelser med HRAS-genændringer, et pædiatrisk MATCH-behandlingsforsøg

NCI-COG Pediatric MATCH (molekylær analyse for valg af terapi) - Fase 2-underprotokol af Tipifarnib hos patienter med tumorer, der rummer HRAS-genomiske ændringer

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Faktiske)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Andre resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Efterforskere

Publikationer og nyttige links

Generelle publikationer

Datoer for undersøgelser

Studer store datoer

Studiestart (Faktiske)

Primær færdiggørelse (Faktiske)

Studieafslutning (Anslået)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Faktiske)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt