Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03233204
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Malignant Solid Neoplasm
  • Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma
  • Ann Arbor Stage IV Childhood Non-Hodgkin Lymphoma
  • Low Grade Glioma
  • Malignant Glioma
  • Recurrent Childhood Central Nervous System Neoplasm
  • Recurrent Childhood Ependymoma
  • Recurrent Childhood Malignant Germ Cell Tumor
  • Recurrent Childhood Non-Hodgkin Lymphoma
  • Recurrent Childhood Rhabdomyosarcoma
  • Recurrent Childhood Soft Tissue Sarcoma
  • Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Recurrent Glioma
  • Recurrent Hepatoblastoma
  • Recurrent Langerhans Cell Histiocytosis
  • Recurrent Malignant Solid Neoplasm
  • Recurrent Medulloblastoma
  • Recurrent Neuroblastoma
  • Recurrent Osteosarcoma
  • Refractory Childhood Malignant Germ Cell Tumor
  • Refractory Ependymoma
  • Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Refractory Glioma
  • Refractory Hepatoblastoma
  • Refractory Langerhans Cell Histiocytosis
  • Refractory Malignant Glioma
  • Refractory Malignant Solid Neoplasm
  • Refractory Medulloblastoma
  • Refractory Neuroblastoma
  • Refractory Non-Hodgkin Lymphoma
  • Refractory Osteosarcoma
  • Refractory Primary Central Nervous System Neoplasm
  • Refractory Rhabdomyosarcoma
  • Refractory Soft Tissue Sarcoma
  • Rhabdoid Tumor
  • Wilms Tumor

Eligibility Criteria

Sex
ALL
Age
12 Months - 21 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This phase II Pediatric MATCH trial studies how well olaparib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with defects in deoxyribonucleic acid (DNA) damage repair genes that have spread to other places in the body (advanced) and have come back (relapsed) or do not respond to treatment (refractory). Olaparib is an inhibitor of PARP, an enzyme that helps repair DNA when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy.

Key Dates

Start date
Sep 14, 2017
Status verified
Dec 2024
Primary completion
Mar 31, 2023
Completion
Jun 30, 2024

Study Design

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

Arms

  • Experimental: Treatment (olaparib)
    Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Objective Response Rate (Complete Response/Partial Response) [ Time Frame: Up to 2 years from study entry ]

Locations (111)

FacilityCityStateZIPSite coordinators
Children's Hospital of AlabamaBirminghamAlabama35233-
Providence Alaska Medical CenterAnchorageAlaska99508-
Banner Children's at DesertMesaArizona85202-
Banner University Medical Center - TucsonTucsonArizona85719-
Arkansas Children's HospitalLittle RockArkansas72202-3591-
Kaiser Permanente Downey Medical CenterDowneyCalifornia90242-
Loma Linda University Medical CenterLoma LindaCalifornia92354-
Miller Children's and Women's Hospital Long BeachLong BeachCalifornia90806-
Children's Hospital Los AngelesLos AngelesCalifornia90027-
Valley Children's HospitalMaderaCalifornia93636-
Kaiser Permanente-OaklandOaklandCalifornia94611-
UCSF Benioff Children's Hospital OaklandOaklandCalifornia94609-
UCSF Medical Center-Mission BaySan FranciscoCalifornia94158-
Children's Hospital ColoradoAuroraColorado80045-
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical CenterDenverColorado80218-
Yale UniversityNew HavenConnecticut06520-
Alfred I duPont Hospital for ChildrenWilmingtonDelaware19803-
Children's National Medical CenterWashington D.C.District of Columbia20010-
University of Florida Health Science Center - GainesvilleGainesvilleFlorida32610-
Nemours Children's Clinic-JacksonvilleJacksonvilleFlorida32207-
Nicklaus Children's HospitalMiamiFlorida33155-
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136-
AdventHealth OrlandoOrlandoFlorida32803-
Arnold Palmer Hospital for ChildrenOrlandoFlorida32806-
Nemours Children's HospitalOrlandoFlorida32827-
Nemours Children's Clinic - PensacolaPensacolaFlorida32504-
Saint Joseph's Hospital/Children's Hospital-TampaTampaFlorida33607-
Children's Healthcare of Atlanta - EglestonAtlantaGeorgia30322-
Saint Luke's Cancer Institute - BoiseBoiseIdaho83712-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
University of IllinoisChicagoIllinois60612-
Saint Jude Midwest AffiliatePeoriaIllinois61637-
Southern Illinois University School of MedicineSpringfieldIllinois62702-
Riley Hospital for ChildrenIndianapolisIndiana46202-
Blank Children's HospitalDes MoinesIowa50309-
University of Iowa/Holden Comprehensive Cancer CenterIowa CityIowa52242-
Norton Children's HospitalLouisvilleKentucky40202-
Children's Hospital New OrleansNew OrleansLouisiana70118-
Ochsner Medical Center JeffersonNew OrleansLouisiana70121-
Eastern Maine Medical CenterBangorMaine04401-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
Sinai Hospital of BaltimoreBaltimoreMaryland21215-
C S Mott Children's HospitalAnn ArborMichigan48109-
Bronson Methodist HospitalKalamazooMichigan49007-
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolisMinnesota55404-
University of Minnesota/Masonic Cancer CenterMinneapolisMinnesota55455-
Mayo Clinic in RochesterRochesterMinnesota55905-
University of Mississippi Medical CenterJacksonMississippi39216-
Children's Mercy Hospitals and ClinicsKansas CityMissouri64108-
Cardinal Glennon Children's Medical CenterSt LouisMissouri63104-
Mercy Hospital Saint LouisSt LouisMissouri63141-
Washington University School of MedicineSt LouisMissouri63110-
Children's Hospital and Medical Center of OmahaOmahaNebraska68114-
University of Nebraska Medical CenterOmahaNebraska68198-
Alliance for Childhood Diseases/Cure 4 the Kids FoundationLas VegasNevada89135-
Summerlin Hospital Medical CenterLas VegasNevada89144-
University Medical Center of Southern NevadaLas VegasNevada89102-
Hackensack University Medical CenterHackensackNew Jersey07601-
Morristown Medical CenterMorristownNew Jersey07960-
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University HospitalNew BrunswickNew Jersey08903-
Albany Medical CenterAlbanyNew York12208-
Roswell Park Cancer InstituteBuffaloNew York14263-
NYU Langone Hospital - Long IslandMineolaNew York11501-
The Steven and Alexandra Cohen Children's Medical Center of New YorkNew Hyde ParkNew York11040-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
NYP/Weill Cornell Medical CenterNew YorkNew York10065-
University of RochesterRochesterNew York14642-
State University of New York Upstate Medical UniversitySyracuseNew York13210-
New York Medical CollegeValhallaNew York10595-
Mission HospitalAshevilleNorth Carolina28801-
Carolinas Medical Center/Levine Cancer InstituteCharlotteNorth Carolina28203-
Novant Health Presbyterian Medical CenterCharlotteNorth Carolina28204-
Duke University Medical CenterDurhamNorth Carolina27710-
Sanford Broadway Medical CenterFargoNorth Dakota58122-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Cleveland Clinic FoundationClevelandOhio44195-
Nationwide Children's HospitalColumbusOhio43205-
Dayton Children's HospitalDaytonOhio45404-
ProMedica Toledo Hospital/Russell J Ebeid Children's HospitalToledoOhio43606-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Legacy Emanuel Children's HospitalPortlandOregon97227-
Oregon Health and Science UniversityPortlandOregon97239-
Geisinger Medical CenterDanvillePennsylvania17822-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Children's Hospital of Pittsburgh of UPMCPittsburghPennsylvania15224-
Prisma Health Richland HospitalColumbiaSouth Carolina29203-
BI-LO Charities Children's Cancer CenterGreenvilleSouth Carolina29605-
Sanford USD Medical Center - Sioux FallsSioux FallsSouth Dakota57117-5134-
East Tennessee Childrens HospitalKnoxvilleTennessee37916-
Saint Jude Children's Research HospitalMemphisTennessee38105-
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-
Dell Children's Medical Center of Central TexasAustinTexas78723-
Medical City Dallas HospitalDallasTexas75230-
UT Southwestern/Simmons Cancer Center-DallasDallasTexas75390-
Cook Children's Medical CenterFort WorthTexas76104-
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHoustonTexas77030-
M D Anderson Cancer CenterHoustonTexas77030-
Children's Hospital of San AntonioSan AntonioTexas78207-
Methodist Children's Hospital of South TexasSan AntonioTexas78229-
Scott and White Memorial HospitalTempleTexas76508-
Primary Children's HospitalSalt Lake CityUtah84113-
University of Vermont and State Agricultural CollegeBurlingtonVermont05405-
Children's Hospital of The King's DaughtersNorfolkVirginia23507-
Virginia Commonwealth University/Massey Cancer CenterRichmondVirginia23298-
Seattle Children's HospitalSeattleWashington98105-
Providence Sacred Heart Medical Center and Children's HospitalSpokaneWashington99204-
Madigan Army Medical CenterTacomaWashington98431-
West Virginia University HealthcareMorgantownWest Virginia26506-
University of Wisconsin Carbone Cancer Center - University HospitalMadisonWisconsin53792-
Children's Hospital of WisconsinMilwaukeeWisconsin53226-

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