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Résztvevőt keres itt: Egyesült Államok3. fázis

A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma

A legfontosabb adatok

Ki végzi
National Cancer Institute (NCI)
Hol
Akron, Albany, Ann Arbor, Atlanta, Aurora, Austin, Baltimore, Bangor, Bethesda, Birmingham, Boise, Boston, Buffalo, Burlington, Chapel Hill, Charleston, Charlotte, Chicago, Cincinnati, Cleveland, Columbia, Columbus, Dallas, Danville, Dayton, Des Moines, Detroit, Durham, El Paso, Fargo, Fort Myers, Fort Worth, Gainesville, Grand Rapids, Greenville, Hartford, Hershey, Hollywood, Honolulu, Houston, Indianapolis, Iowa City, Jackson, Jacksonville, Kansas City, Knoxville, Lexington, Little Rock, Loma Linda, Long Beach, Los Angeles, Louisville, Lubbock, Madison, Memphis, Mesa, Miami, Milwaukee, Mineola, Minneapolis, Morgantown, Morristown, Nashville, New Haven, New Hyde Park, New Orleans, New York, Norfolk, Oakland, Oklahoma City, Omaha, Orange, Orlando, Palo Alto, Pensacola, Peoria, Philadelphia, Phoenix, Pittsburgh, Portland, Providence, Richmond, Roanoke, Rochester, Royal Oak, Salt Lake City, San Antonio, San Diego, San Francisco, Scarborough, Seattle, Spokane, Springfield, St Louis, St. Petersburg, Syracuse, Tacoma, Tampa, Valhalla, Washington D.C., Wilmington és Winston-Salem (Egyesült Államok)Mind a 124 helyszín megnézéseMég 2 másik országban, 8 helyszínen
Azonosító
Állapot
Toboroz
Fázis
3. fázis
Résztvevők
170 fő, tervezett
Kezdés
2020. jan. 31.
Várható befejezés
2030. dec. 31.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • Biospecimen Collection
  • Carboplatin
  • Echocardiography Test
  • Magnetic Resonance Imaging
  • Questionnaire Administration
  • Selumetinib Sulfate
  • Vincristine Sulfate
A regiszteradat frissítve
2026. november 12.

Ki vehet részt

Életkor
2 év – 21 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 46 feltétel megnézéseKevesebb

Ki vehet részt

  • Patients must be >= 2 years and =< 21 years at the time of enrollment
  • Patients must have a body surface area (BSA) of >= 0.5 m\^2 at enrollment
  • Patients must have non-neurofibromatosis type 1 (non-NF1) low-grade glioma (LGG) without a BRAFV600E mutation as confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1 (NCT02402244) Childhood Cancer Data Initiative (CCDI)-MCI, or accepted Clinical Laboratory Improvement Act (CLIA)-certified test and that has not been treated with any modality besides surgery. Note: Patients may be newly-diagnosed OR previously diagnosed, and there is no required time frame between biopsy/surgery and treatment initiation; Patients with residual tumor after resection or progressive tumor after initial diagnosis (with or without surgery) who have not received treatment (chemotherapy and/or radiation) are eligible; Patients must have two-dimensional measurable tumor >= 1 cm\^2 to be eligible; Patients with ependymoma are not eligible
  • Eligible histologies will include all tumors considered low-grade glioma or low-grade astrocytoma (World Health Organization [WHO] grade I and II) by 5th edition WHO classification of central nervous system (CNS) tumors with the exception of subependymal giant cell astrocytoma
  • Patients with metastatic disease or multiple independent primary LGG are eligible
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m\^2 OR a serum creatinine based on age/sex as follows (performed within 7 days prior to enrollment):; Age: Maximum Serum Creatinine (mg/dL); 2 to < 6 years: 0.8 mg/dL (male); 0.8 mg/dL (female); 6 to < 10 years: 1 mg/dL (male); 1 mg/dL (female); 10 to < 13 years: 1.2 mg/dL (male); 1.2 mg/dL (female); 13 to < 16 years: 1.5 mg/dL (male); 1.4 mg/dL (female); >= 16 years: 1.7 mg/dL (male); 1.4 mg/dL (female)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (performed within 7 days prior to enrollment) (children with a diagnosis of Gilbert's syndrome will be allowed on study regardless of their total and indirect [unconjugated] bilirubin levels as long as their direct [conjugated] bilirubin is < 3.1 mg/dL)
  • Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (performed within 7 days prior to enrollment). For the purpose of this study, the ULN for SGPT is 45 U/L
  • Albumin >= 2 g/dL (performed within 7 days prior to enrollment)
  • Left ventricular ejection fraction (LVEF) >= 53% (or institutional normal; if the LVEF result is given as a range of values, then the upper value of the range will be used) by echocardiogram (performed within 4 weeks prior to enrollment)
  • Corrected QT (QTc) interval =< 450 msec by electrocardiography (EKG) (performed within 4 weeks prior to enrollment)
  • Absolute neutrophil count >= 1,000/uL (unsupported) (performed within 7 days prior to enrollment)
  • Platelets >= 100,000/uL (unsupported) (performed within 7 days prior to enrollment)
  • Hemoglobin >= 8 g/dL (may be supported) (performed within 7 days prior to enrollment)
  • Patients with a known seizure disorder must be stable and must not have experienced a significant increase in seizure frequency within 2 weeks prior to enrollment
  • Patients 2-17 years of age must have a blood pressure that is =< 95th percentile for age, height, and sex at the time of enrollment (with or without the use of anti-hypertensive medications)
  • Patients >= 18 years of age must have a blood pressure =< 130/80 mmHg at the time of enrollment (with or without the use of anti-hypertensive medications)
  • Note for patients of all ages: Adequate blood pressure can be achieved using medication for the treatment of hypertension
  • All patients must have ophthalmology toxicity assessments performed within 8 weeks prior to enrollment
  • For all patients, an MRI of the brain (with orbital cuts for optic pathway tumors) and/or spine (depending on the site(s) of primary disease) with and without contrast must be performed within 8 weeks prior to enrollment
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
  • Patients must have the ability to swallow whole capsules
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
  • All patients have signed an appropriate consent form and Health Insurance Portability and Accountability Act (HIPAA) authorization form (if applicable)
  • All patients have been consented and enrolled on APEC14B1 (NCT02402244) Part A for Pre-Enrollment Eligibility Screening for ACNS1833

Ki nem vehet részt

  • Patients must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant. Prior surgical intervention (with the exclusion of laser interstitial thermal therapy [LITT]) is permitted
  • Patients with a concurrent malignancy or history of treatment (other than surgery) for another tumor within the last year are ineligible
  • Patients may not be receiving any other investigational agents
  • Female patients who are pregnant are not eligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 1 week after stopping study therapy are not eligible; Note: Women study participants of child-bearing potential must use acceptable contraception during the study and for 1 week (7 days) after the last dose of selumetinib. Men study participants with sexual partners who are pregnant or who are of child-bearing potential must use acceptable contraception during the study and for 1 week (7 days) after the last dose of study agent. Acceptable contraception includes implants, injectables, or oral contraceptives (all combined with barrier methods), some intrauterine devices (IUDs), vasectomy or abstinence
  • New York Health Association (NYHA) class II-IV prior or current cardiomyopathy
  • Supplementation with vitamin E greater than 100% of the daily recommended dose. Any multivitamin containing vitamin E must be stopped prior to study enrollment even if less than 100% of the daily recommended dosing for vitamin E
  • Surgery within 2 weeks prior to enrollment, with the exception of surgical biopsy, placement of a vascular access device or cerebral spinal fluid (CSF) diverting procedure such as endoscopic third ventriculostomy (ETV) and ventriculoperitoneal (VP) shunt; Note: Patients must have healed from any prior surgery
  • Patients with any serious medical or psychiatric illness/condition, including substance use disorders or ophthalmological conditions, likely in the judgment of the investigator to interfere or limit compliance with study requirements/treatment
  • Known genetic disorder that increases risk for coronary artery disease. Note: The presence of dyslipidemia in a family with a history of myocardial infarction is not in itself an exclusion unless there is a known genetic disorder documented
  • Symptomatic heart failure
  • Severe valvular heart disease
  • History of atrial fibrillation
  • Current or past history of central serous retinopathy
  • Current or past history of retinal vein occlusion or retinal detachment
  • Patients who have an uncontrolled infection are not eligible
  • Patients with uncontrolled glaucoma; If checking pressure is clinically indicated, patients with intraocular pressure (IOP) > 22 mmHg or ULN adjusted by age are not eligible
  • Patients with diffuse intrinsic pontine tumors as seen on MRI (> 2/3 of pons involvement on imaging) are not eligible even if biopsy reveals grade I/II histology
  • Patients who, in the opinion of the investigator, are not able to comply with the study procedures are not eligible
  • Lactating females who plan to breastfeed their infants are not eligible

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 2 és 21 év között vagy?

Helyszínek itt: Egyesült Államok

Még 2 másik országban, 8 helyszínen

  • Children's Hospital Medical Center of AkronAkron, Egyesült ÁllamokContact: Lauren R. Draper (principal investigator)Résztvevőt keres
  • Albany Medical CenterAlbany, Egyesült ÁllamokContact: Lauren R. Weintraub (principal investigator)Résztvevőt keres
  • C S Mott Children's HospitalAnn Arbor, Egyesült ÁllamokContact: Andrea T. Franson (principal investigator)Résztvevőt keres
  • Children's Healthcare of Atlanta - Arthur M Blank HospitalAtlanta, Egyesült ÁllamokContact: Jason R. Fangusaro (principal investigator)Résztvevőt keres
  • Children's Hospital ColoradoAurora, Egyesült ÁllamokContact: Jean M. Mulcahy Levy (principal investigator)Résztvevőt keres
  • Dell Children's Medical Center of Central TexasAustin, Egyesült ÁllamokContact: Shannon M. Cohn (principal investigator)Résztvevőt keres
  • Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimore, Egyesült ÁllamokContact: Kenneth J. Cohen (principal investigator)Résztvevőt keres
  • Eastern Maine Medical CenterBangor, Egyesült ÁllamokRésztvevőt keres
  • Walter Reed National Military Medical CenterBethesda, Egyesült ÁllamokContact: Kip R. Hartman (principal investigator)Résztvevőt keres
  • Children's Hospital of AlabamaBirmingham, Egyesült ÁllamokContact: Laura K. Metrock (principal investigator)Résztvevőt keres
  • Saint Luke's Cancer Institute - BoiseBoise, Egyesült ÁllamokContact: Martha M. Pacheco (principal investigator)Résztvevőt keres
  • Dana-Farber Cancer InstituteBoston, Egyesült ÁllamokNo longer taking part
  • Massachusetts General Hospital Cancer CenterBoston, Egyesült ÁllamokNo longer taking part
  • Roswell Park Cancer InstituteBuffalo, Egyesült ÁllamokContact: Matthew J. Barth (principal investigator)Résztvevőt keres
  • University of Vermont and State Agricultural CollegeBurlington, Egyesült ÁllamokContact: Jessica L. Heath (principal investigator)Résztvevőt keres
  • UNC Lineberger Comprehensive Cancer CenterChapel Hill, Egyesült ÁllamokContact: David E. Kram (principal investigator)Résztvevőt keres
  • Medical University of South CarolinaCharleston, Egyesült ÁllamokContact: Jacqueline M. Kraveka (principal investigator)Résztvevőt keres
  • Carolinas Medical Center/Levine Cancer InstituteCharlotte, Egyesült ÁllamokContact: Joel A. Kaplan (principal investigator)Résztvevőt keres
  • Lurie Children's Hospital-ChicagoChicago, Egyesült ÁllamokContact: Angela J. Waanders (principal investigator)Résztvevőt keres
  • University of Chicago Comprehensive Cancer CenterChicago, Egyesült ÁllamokContact: Wendy S. Darlington (principal investigator)Résztvevőt keres
  • University of IllinoisChicago, Egyesült ÁllamokContact: Dipti S. Dighe (principal investigator)Résztvevőt keres
  • Cincinnati Children's Hospital Medical CenterCincinnati, Egyesült ÁllamokContact: Peter M. de Blank (principal investigator)Résztvevőt keres
  • Rainbow Babies and Childrens HospitalCleveland, Egyesült ÁllamokContact: Duncan S. Stearns (principal investigator)Résztvevőt keres
  • Prisma Health Richland HospitalColumbia, Egyesült ÁllamokContact: Stuart L. Cramer (principal investigator)Résztvevőt keres
  • Nationwide Children's HospitalColumbus, Egyesült ÁllamokContact: Mark A. Ranalli (principal investigator)Résztvevőt keres
  • UT Southwestern/Simmons Cancer Center-DallasDallas, Egyesült ÁllamokContact: Daniel C. Bowers (principal investigator)Résztvevőt keres
  • Geisinger Medical CenterDanville, Egyesült ÁllamokContact: Jagadeesh Ramdas (principal investigator)Résztvevőt keres
  • Dayton Children's HospitalDayton, Egyesült ÁllamokContact: Jordan M. Wright (principal investigator)Résztvevőt keres
  • Blank Children's HospitalDes Moines, Egyesült ÁllamokContact: Samantha L. Mallory (principal investigator)Résztvevőt keres
  • Children's Hospital of MichiganDetroit, Egyesült ÁllamokContact: Stephanie A. Toll (principal investigator)Résztvevőt keres
  • Duke University Medical CenterDurham, Egyesült ÁllamokContact: Jessica M. Sun (principal investigator)Résztvevőt keres
  • El Paso Children's HospitalEl Paso, Egyesült ÁllamokContact: Benjamin Carcamo (principal investigator)Résztvevőt keres
  • Sanford Broadway Medical CenterFargo, Egyesült ÁllamokContact: Samuel J. Milanovich (principal investigator)Résztvevőt keres
  • Golisano Children's Hospital of Southwest FloridaFort Myers, Egyesült ÁllamokContact: Emad K. Salman (principal investigator)Résztvevőt keres
  • Cook Children's Medical CenterFort Worth, Egyesült ÁllamokContact: Sibo Zhao (principal investigator)Résztvevőt keres
  • UF Health Cancer Institute - GainesvilleGainesville, Egyesült ÁllamokNo longer taking part
  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's HospitalGrand Rapids, Egyesült ÁllamokContact: Kathleen Y. Butler (principal investigator)Résztvevőt keres
  • BI-LO Charities Children's Cancer CenterGreenville, Egyesült ÁllamokContact: Aniket Saha (principal investigator)Résztvevőt keres
  • East Carolina UniversityGreenville, Egyesült ÁllamokContact: Andrea R. Whitfield (principal investigator)Résztvevőt keres
  • Connecticut Children's Medical CenterHartford, Egyesült ÁllamokContact: Michael S. Isakoff (principal investigator)Résztvevőt keres
  • Penn State Children's HospitalHershey, Egyesült ÁllamokContact: Lisa M. McGregor (principal investigator)Résztvevőt keres
  • Memorial Regional Hospital/Joe DiMaggio Children's HospitalHollywood, Egyesült ÁllamokContact: Iftikhar Hanif (principal investigator)Résztvevőt keres
  • Kapiolani Medical Center for Women and ChildrenHonolulu, Egyesült ÁllamokContact: Wade T. Kyono (principal investigator)Résztvevőt keres
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHouston, Egyesült ÁllamokContact: Murali M. Chintagumpala (principal investigator)Résztvevőt keres
  • UT MD Anderson Cancer CenterHouston, Egyesült ÁllamokContact: Najat C. Daw (principal investigator)Résztvevőt keres
  • Ascension Saint Vincent Indianapolis HospitalIndianapolis, Egyesült ÁllamokContact: Jessica F. Goodman (principal investigator)Résztvevőt keres
  • Riley Hospital for ChildrenIndianapolis, Egyesült ÁllamokContact: Sandeep Batra (principal investigator)Résztvevőt keres
  • University of Iowa/Holden Comprehensive Cancer CenterIowa City, Egyesült ÁllamokContact: Andrew P. Groves (principal investigator)Résztvevőt keres
  • University of Mississippi Medical CenterJackson, Egyesült ÁllamokContact: Amanda Strobel (principal investigator)Résztvevőt keres
  • Nemours Children's Clinic-JacksonvilleJacksonville, Egyesült ÁllamokContact: Sridhi Patel (principal investigator)Résztvevőt keres
  • Children's Mercy Hospitals and ClinicsKansas City, Egyesült ÁllamokContact: Keith J. August (principal investigator)Résztvevőt keres
  • East Tennessee Childrens HospitalKnoxville, Egyesült ÁllamokContact: Susan E. Spiller (principal investigator)Résztvevőt keres
  • University of Kentucky/Markey Cancer CenterLexington, Egyesült ÁllamokContact: James T. Badgett (principal investigator)Résztvevőt keres
  • Arkansas Children's HospitalLittle Rock, Egyesült ÁllamokContact: Michael W. Bishop (principal investigator)Résztvevőt keres
  • Loma Linda University Medical CenterLoma Linda, Egyesült ÁllamokContact: Albert Kheradpour (principal investigator)Résztvevőt keres
  • Miller Children's and Women's Hospital Long BeachLong Beach, Egyesült ÁllamokContact: Jacqueline N. Casillas (principal investigator)Résztvevőt keres
  • Cedars-Sinai Medical CenterLos Angeles, Egyesült ÁllamokContact: Fataneh (Fae) Majlessipour (principal investigator)Résztvevőt keres
  • Children's Hospital Los AngelesLos Angeles, Egyesült ÁllamokContact: Nathan J. Robison (principal investigator)Résztvevőt keres
  • Mattel Children's Hospital UCLALos Angeles, Egyesült ÁllamokContact: Satiro N. De Oliveira (principal investigator)Résztvevőt keres
  • Norton Children's HospitalLouisville, Egyesült ÁllamokContact: Michael J. Ferguson (principal investigator)Résztvevőt keres
  • Covenant Children's HospitalLubbock, Egyesült ÁllamokContact: Kishor M. Bhende (principal investigator)Résztvevőt keres
  • UMC Cancer Center / UMC Health SystemLubbock, Egyesült ÁllamokContact: Erin K. Barr (principal investigator)Résztvevőt keres
  • University of Wisconsin Carbone Cancer Center - University HospitalMadison, Egyesült ÁllamokContact: Nicholas J. Pytel (principal investigator)Résztvevőt keres
  • Saint Jude Children's Research HospitalMemphis, Egyesült ÁllamokContact: Anna Vinitsky (principal investigator)Résztvevőt keres
  • Banner Children's at DesertMesa, Egyesült ÁllamokContact: Joseph C. Torkildson (principal investigator)Résztvevőt keres
  • Nicklaus Children's HospitalMiami, Egyesült ÁllamokContact: Ziad A. Khatib (principal investigator)Résztvevőt keres
  • University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, Egyesült ÁllamokNo longer taking part
  • Children's Hospital of WisconsinMilwaukee, Egyesült ÁllamokContact: Sarah Rumler (principal investigator)Résztvevőt keres
  • NYU Langone Hospital - Long IslandMineola, Egyesült ÁllamokContact: Chana L. Glasser (principal investigator)Résztvevőt keres
  • Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, Egyesült ÁllamokContact: Michael K. Richards (principal investigator)Résztvevőt keres
  • University of Minnesota/Masonic Cancer CenterMinneapolis, Egyesült ÁllamokContact: Clay M. Hoerig (principal investigator)Résztvevőt keres
  • West Virginia University HealthcareMorgantown, Egyesült ÁllamokContact: Ashley E. Meyer (principal investigator)Résztvevőt keres
  • Morristown Medical CenterMorristown, Egyesült ÁllamokContact: Kathryn L. Laurie (principal investigator)Résztvevőt keres
  • Vanderbilt University/Ingram Cancer CenterNashville, Egyesült ÁllamokContact: Devang J. Pastakia (principal investigator)Résztvevőt keres
  • Yale UniversityNew Haven, Egyesült ÁllamokContact: Asher M. Marks (principal investigator)Résztvevőt keres
  • The Steven and Alexandra Cohen Children's Medical Center of New YorkNew Hyde Park, Egyesült ÁllamokContact: Mark P. Atlas (principal investigator)Résztvevőt keres
  • Children's Hospital New OrleansNew Orleans, Egyesült ÁllamokContact: Maria C. Velez-Yanguas (principal investigator)Résztvevőt keres
  • Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew York, Egyesült ÁllamokContact: Elizabeth A. Raetz (principal investigator)Résztvevőt keres
  • Memorial Sloan-Kettering Cancer CenterNew York, Egyesült ÁllamokContact: Sameer Farouk Sait (principal investigator)Résztvevőt keres
  • Children's Hospital of The King's DaughtersNorfolk, Egyesült ÁllamokContact: Melissa S. Mark (principal investigator)Résztvevőt keres
  • Kaiser Permanente-OaklandOakland, Egyesült ÁllamokContact: Aarati V. Rao (principal investigator)Résztvevőt keres
  • University of Oklahoma Health Sciences CenterOklahoma City, Egyesült ÁllamokContact: Rene Y. McNall-Knapp (principal investigator)Résztvevőt keres
  • Children's Hospital and Medical Center of OmahaOmaha, Egyesült ÁllamokContact: Jill C. Beck (principal investigator)Résztvevőt keres
  • University of Nebraska Medical CenterOmaha, Egyesült ÁllamokContact: Jill C. Beck (principal investigator)Résztvevőt keres
  • Children's Hospital of Orange CountyOrange, Egyesült ÁllamokContact: Elyssa M. Rubin (principal investigator)Résztvevőt keres
  • AdventHealth OrlandoOrlando, Egyesült ÁllamokContact: Fouad M. Hajjar (principal investigator)Résztvevőt keres
  • Arnold Palmer Hospital for ChildrenOrlando, Egyesült ÁllamokContact: Zhongbo Hu (principal investigator)Résztvevőt keres
  • Nemours Children's HospitalOrlando, Egyesült ÁllamokContact: Sridhi Patel (principal investigator)Résztvevőt keres
  • Lucile Packard Children's Hospital Stanford UniversityPalo Alto, Egyesült ÁllamokContact: Jay Michael S. Balagtas (principal investigator)Résztvevőt keres
  • Nemours Children's Clinic - PensacolaPensacola, Egyesült ÁllamokContact: Jeffrey H. Schwartz (principal investigator)Résztvevőt keres
  • Sacred Heart HospitalPensacola, Egyesült ÁllamokNo longer taking part
  • OSF Children's Hospital of IllinoisPeoria, Egyesült ÁllamokContact: Prerna Kumar (principal investigator)Résztvevőt keres
  • Children's Hospital of PhiladelphiaPhiladelphia, Egyesült ÁllamokContact: Michael J. Fisher (principal investigator)Résztvevőt keres
  • Saint Christopher's Hospital for ChildrenPhiladelphia, Egyesült ÁllamokContact: Gregory E. Halligan (principal investigator)Résztvevőt keres
  • Phoenix Childrens HospitalPhoenix, Egyesült ÁllamokContact: Kazuhiro Sabet (principal investigator)Résztvevőt keres
  • Children's Hospital of Pittsburgh of UPMCPittsburgh, Egyesült ÁllamokContact: James T. Felker (principal investigator)Résztvevőt keres
  • Oregon Health and Science UniversityPortland, Egyesült ÁllamokContact: Neha J. Patel (principal investigator)Résztvevőt keres
  • Rhode Island HospitalProvidence, Egyesült ÁllamokContact: Bradley DeNardo (principal investigator)Résztvevőt keres
  • VCU Massey Comprehensive Cancer CenterRichmond, Egyesült ÁllamokContact: Christopher Park (principal investigator)Résztvevőt keres
  • Carilion Children'sRoanoke, Egyesült ÁllamokContact: Erwood G. Edwards (principal investigator)Résztvevőt keres
  • Mayo Clinic in RochesterRochester, Egyesült ÁllamokContact: Joseph Z. Wilson (principal investigator)Résztvevőt keres
  • University of RochesterRochester, Egyesült ÁllamokNo longer taking part
  • Corewell Health Children'sRoyal Oak, Egyesült ÁllamokNo longer taking part
  • Primary Children's HospitalSalt Lake City, Egyesült ÁllamokContact: Priya Chan (principal investigator)Résztvevőt keres
  • Children's Hospital of San AntonioSan Antonio, Egyesült ÁllamokContact: Julie Voeller (principal investigator)Résztvevőt keres
  • Methodist Children's Hospital of South TexasSan Antonio, Egyesült ÁllamokContact: Jose M. Esquilin (principal investigator)Résztvevőt keres
  • University of Texas Health Science Center at San AntonioSan Antonio, Egyesült ÁllamokContact: Shafqat Shah (principal investigator)Résztvevőt keres
  • Rady Children's Hospital - San DiegoSan Diego, Egyesült ÁllamokContact: William D. Roberts (principal investigator)Résztvevőt keres
  • UCSF Medical Center-Mission BaySan Francisco, Egyesült ÁllamokContact: Alyssa T. Reddy (principal investigator)Résztvevőt keres
  • Maine Children's Cancer ProgramScarborough, Egyesült ÁllamokContact: Stanley Chaleff (principal investigator)Résztvevőt keres
  • Seattle Children's HospitalSeattle, Egyesült ÁllamokContact: Sarah E. Leary (principal investigator)Résztvevőt keres
  • Providence Sacred Heart Medical Center and Children's HospitalSpokane, Egyesült ÁllamokContact: Judy L. Felgenhauer (principal investigator)Résztvevőt keres
  • Southern Illinois University School of MedicineSpringfield, Egyesült ÁllamokContact: Gregory P. Brandt (principal investigator)Résztvevőt keres
  • Cardinal Glennon Children's Medical CenterSt Louis, Egyesült ÁllamokContact: William S. Ferguson (principal investigator)Résztvevőt keres
  • Washington University School of MedicineSt Louis, Egyesült ÁllamokContact: Andrew S. Cluster (principal investigator)Résztvevőt keres
  • Johns Hopkins All Children's HospitalSt. Petersburg, Egyesült ÁllamokContact: Stacie L. Stapleton (principal investigator)Résztvevőt keres
  • State University of New York Upstate Medical UniversitySyracuse, Egyesült ÁllamokContact: Melanie A. Comito (principal investigator)Résztvevőt keres
  • Madigan Army Medical CenterTacoma, Egyesült ÁllamokContact: Melissa A. Forouhar (principal investigator)Résztvevőt keres
  • Mary Bridge Children's Hospital and Health CenterTacoma, Egyesült ÁllamokContact: Robert G. Irwin (principal investigator)Résztvevőt keres
  • Saint Joseph's Hospital/Children's Hospital-TampaTampa, Egyesült ÁllamokContact: Don E. Eslin (principal investigator)Résztvevőt keres
  • New York Medical CollegeValhalla, Egyesült ÁllamokContact: Andrew J. Bellantoni (principal investigator)Résztvevőt keres
  • Children's National Medical CenterWashington D.C., Egyesült ÁllamokContact: Jeffrey S. Dome (principal investigator)Résztvevőt keres
  • Alfred I duPont Hospital for ChildrenWilmington, Egyesült ÁllamokContact: Sridhi Patel (principal investigator)Résztvevőt keres
  • Wake Forest University Health SciencesWinston-Salem, Egyesült ÁllamokContact: Sarah Supples (principal investigator)Résztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

This phase III trial compares the effect of selumetinib versus the standard of care treatment with carboplatin and vincristine (CV) in treating patients with newly diagnosed or previously untreated low-grade glioma (LGG) that does not have a genetic abnormality called BRAFV600E mutation and is not associated with systemic neurofibromatosis type 1. Selumetinib works by blocking some of the enzymes needed for cell growth and may kill tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. The overall goal of this study is to see if selumetinib works just as well as the standard treatment of CV for patients with LGG. Another goal of this study is to compare the effects of selumetinib versus CV in subjects with LGG to find out which is better. Additionally, this trial will also examine if treatment with selumetinib improves the quality of life for subjects who take it.

A vizsgálat 2 csoportja

  • Arm I (vincristine sulfate, carboplatin)Már használt kezelés, összehasonlításként

    INDUCTION: Patients receive vincristine sulfate IV on days 1, 8, 15, 22, 29, 36, 43, 50, 57, and 64, and carboplatin IV over 60 minutes on days 1, 8, 15, 22, 43, 50, 57, and 64 in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and MRI throughout the trial. MAINTENANCE: Patients receive vincristine sulfate IV on days 1, 8, and 15, and carboplatin IV over 60 minutes on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 42 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and MRI throughout the trial.

    Kezelés: Biospecimen Collection, Carboplatin, Magnetic Resonance Imaging, Questionnaire Administration és Vincristine Sulfate

  • Arm II (selumetinib sulfate)A vizsgált kezelés

    Patients receive selumetinib sulfate PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 27 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO at baseline and undergo collection of blood and MRI throughout the trial.

    Kezelés: Biospecimen Collection, Echocardiography Test, Magnetic Resonance Imaging, Questionnaire Administration és Selumetinib Sulfate

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine Versus Selumetinib (NSC# 748727) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) Not Associated With BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)
Illeszkedési kérdések
Forrás: NCT04166409: ki vehet részt
A regiszteradat frissítve
2026. november 12.