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Tipifarnib pro léčbu pokročilých pevných nádorů, lymfomů nebo histiocytárních poruch s alteracemi genu HRAS, dětská zkouška MATCH léčby

10. listopadu 2026 aktualizováno: National Cancer Institute (NCI)

NCI-COG Pediatric MATCH (Molekulární analýza pro volbu terapie) – Fáze 2 Subprotokol tipifarnibu u pacientů s nádory obsahujícími genomické změny 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.

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Lék: Tipifarnib

Detailní popis

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 studie

Intervenční

Zápis (Aktuální)

Fáze

Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

1 rok až 21 let (Dítě, Dospělý)

Přijímá zdravé dobrovolníky

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Primární účel: Léčba
Přidělení: N/A
Intervenční model: Přiřazení jedné skupiny
Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm Skupina účastníků / Arm Skupina nebo podskupina účastníků klinické studie, která podle protokolu studie dostává konkrétní intervenci/léčbu nebo žádnou intervenci.	Intervence / Léčba Intervence / Léčba Proces nebo akce, na které se klinická studie zaměřuje. Intervence zahrnují léky, zdravotnická zařízení, postupy, vakcíny a další produkty, které jsou buď zkoušené nebo již dostupné. Intervence mohou také zahrnovat neinvazivní přístupy, jako je edukace nebo úprava stravy a cvičení.
Experimentální: 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.	Lék: Tipifarnib Tipifarnib tablets Ostatní jména: R115777 Zarnestra

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Objective Response Rate (Complete Response + Partial Response) in Pediatric Patients Treated With Tipifarnib Časové okno: 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

Sekundární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Percentage of Patients Experiencing Grade 3 or Higher Adverse Events Časové okno: 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) Časové okno: 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

Další výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Biomarker Analysis Časové okno: 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 Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

National Cancer Institute (NCI)

Vyšetřovatelé

Vrchní vyšetřovatel: Christine A Pratilas, Children's Oncology Group

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

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.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

13. října 2020

Primární dokončení (Aktuální)

31. března 2024

Dokončení studie (Odhadovaný)

30. září 2027

Termíny zápisu do studia

První předloženo

25. února 2020

První předloženo, které splnilo kritéria kontroly kvality

25. února 2020

První zveřejněno (Aktuální)

26. února 2020

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. listopadu 2026

Naposledy ověřeno

1. října 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

NCI-2020-01015
U10CA180886 (Grant/smlouva NIH USA)
NCI-2020-01015 (Identifikátor registru: CTRP (Clinical Trial Reporting Program))
APEC1621M (Jiný identifikátor: CTEP)
APEC1621M (Jiný identifikátor: Children's Oncology Group)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

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Studuje produkt zařízení regulovaný americkým úřadem FDA

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Tipifarnib pro léčbu pokročilých pevných nádorů, lymfomů nebo histiocytárních poruch s alteracemi genu HRAS, dětská zkouška MATCH léčby

NCI-COG Pediatric MATCH (Molekulární analýza pro volbu terapie) – Fáze 2 Subprotokol tipifarnibu u pacientů s nádory obsahujícími genomické změny HRAS

Přehled studie

Postavení

Podmínky

Intervence / Léčba

Detailní popis

Typ studie

Zápis (Aktuální)

Fáze

Kontakty a umístění

Studijní místa

Kritéria účasti

Kritéria způsobilosti

Věk způsobilý ke studiu

Přijímá zdravé dobrovolníky

Pohlaví způsobilá ke studiu

Popis

Studijní plán

Jak je studie koncipována?

Detaily designu

Počet zbraní

Zbraně a zásahy

Skupina účastníků / Arm

Intervence / Léčba

Co je měření studie?

Primární výstupní opatření

Měření výsledku

Popis opatření

Časové okno

Sekundární výstupní opatření

Měření výsledku

Popis opatření

Časové okno

Další výstupní opatření

Měření výsledku

Popis opatření

Časové okno

Spolupracovníci a vyšetřovatelé

Sponzor

Vyšetřovatelé

Publikace a užitečné odkazy

Obecné publikace

Termíny studijních záznamů

Hlavní termíny studia

Začátek studia (Aktuální)

Primární dokončení (Aktuální)

Dokončení studie (Odhadovaný)

Termíny zápisu do studia

První předloženo

První předloženo, které splnilo kritéria kontroly kvality

První zveřejněno (Aktuální)

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

Naposledy ověřeno

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Popis plánu IPD

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Studuje produkt zařízení regulovaný americkým úřadem FDA