Trametinib in Treating Patients With Relapsed or Refractory Juvenile Myelomonocytic Leukemia

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03190915
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Juvenile Myelomonocytic Leukemia
  • Neurofibromatosis Type 1

Eligibility Criteria

Sex
ALL
Age
1 Month - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Bone Marrow Aspiration and Biopsy — PROCEDURE
    Undergo bone marrow aspiration or biopsy
  • Trametinib — DRUG
    Given PO

Study Details

This phase II trial studies how well trametinib works in treating patients with juvenile myelomonocytic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Sep 9, 2018
Status verified
Jan 2026
Primary completion
Mar 31, 2023
Completion
Oct 3, 2026

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (trametinib)
    Patients receive trametinib PO QD on days 1-28 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a bone marrow aspiration or biopsy at baseline, on day 28 of cycles 1 and 2, at all subsequent odd numbered cycles, and at end of treatment.

Primary Outcome Measure

Objective Response [ Time Frame: 12 cycles (1 cycle = 28 days) ]

Locations (57)

FacilityCityStateZIPSite coordinators
Children's Hospital of AlabamaBirminghamAlabama35233-
Phoenix Childrens HospitalPhoenixArizona85016-
Arkansas Children's HospitalLittle RockArkansas72202-3591-
Kaiser Permanente Downey Medical CenterDowneyCalifornia90242-
Loma Linda University Medical CenterLoma LindaCalifornia92354-
Kaiser Permanente-OaklandOaklandCalifornia94611-
Children's Hospital of Orange CountyOrangeCalifornia92868-
Lucile Packard Children's Hospital Stanford UniversityPalo AltoCalifornia94304-
UCSF Medical Center-Mission BaySan FranciscoCalifornia94158-
Children's Hospital ColoradoAuroraColorado80045-
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical CenterDenverColorado80218-
Connecticut Children's Medical CenterHartfordConnecticut06106-
Alfred I duPont Hospital for ChildrenWilmingtonDelaware19803-
Children's National Medical CenterWashington D.C.District of Columbia20010-
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007-
Nemours Children's Clinic-JacksonvilleJacksonvilleFlorida32207-
Nicklaus Children's HospitalMiamiFlorida33155-
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136-
Arnold Palmer Hospital for ChildrenOrlandoFlorida32806-
Nemours Children's HospitalOrlandoFlorida32827-
Saint Joseph's Hospital/Children's Hospital-TampaTampaFlorida33607-
Children's Healthcare of Atlanta - Arthur M Blank HospitalAtlantaGeorgia30329-
Lurie Children's Hospital-ChicagoChicagoIllinois60611-
OSF Children's Hospital of IllinoisPeoriaIllinois61637-
Riley Hospital for ChildrenIndianapolisIndiana46202-
University of Iowa/Holden Comprehensive Cancer CenterIowa CityIowa52242-
University of Kentucky/Markey Cancer CenterLexingtonKentucky40536-
National Institutes of Health Clinical CenterBethesdaMaryland20892-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
C S Mott Children's HospitalAnn ArborMichigan48109-
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolisMinnesota55404-
University of Minnesota/Masonic Cancer CenterMinneapolisMinnesota55455-
Children's Mercy Hospitals and ClinicsKansas CityMissouri64108-
Washington University School of MedicineSt LouisMissouri63110-
The Steven and Alexandra Cohen Children's Medical Center of New YorkNew Hyde ParkNew York11040-
Mount Sinai HospitalNew YorkNew York10029-
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
Carolinas Medical Center/Levine Cancer InstituteCharlotteNorth Carolina28203-
Duke University Medical CenterDurhamNorth Carolina27710-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Nationwide Children's HospitalColumbusOhio43205-
Dayton Children's HospitalDaytonOhio45404-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Oregon Health and Science UniversityPortlandOregon97239-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Children's Hospital of Pittsburgh of UPMCPittsburghPennsylvania15224-
BI-LO Charities Children's Cancer CenterGreenvilleSouth Carolina29605-
Saint Jude Children's Research HospitalMemphisTennessee38105-
The Children's Hospital at TriStar CentennialNashvilleTennessee37203-
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-
Dell Children's Medical Center of Central TexasAustinTexas78723-
UT Southwestern/Simmons Cancer Center-DallasDallasTexas75390-
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHoustonTexas77030-
Methodist Children's Hospital of South TexasSan AntonioTexas78229-
Primary Children's HospitalSalt Lake CityUtah84113-
Seattle Children's HospitalSeattleWashington98105-
Children's Hospital of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By research site
Children's Hospital of Alabama· Birmingham, ALPhoenix Childrens Hospital· Phoenix, AZArkansas Children's Hospital· Little Rock, ARKaiser Permanente Downey Medical Center· Downey, CALoma Linda University Medical Center· Loma Linda, CAKaiser Permanente-Oakland· Oakland, CA

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