NCT03233204CompletedPhase 2
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)
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- A Phase 2 Subprotocol of Olaparib in Patients With Tumors Harboring Defects in DNA Damage Repair Genes
Source: ClinicalTrials.gov · Last updated 11 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 25 Jul 2017
- Start date
- 14 Sept 2017
- Primary completion date
- 31 Mar 2023
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Neuroblastoma, Kidney cancer, Childhood cancers, Sarcoma
- NCT number
- NCT03233204
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 6
- From 14 Sept 2017 to the primary completion date, 31 Mar 2023
- 113 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant medications
- Corticosteroids: 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
- Investigational drugs: patients who are currently receiving another investigational drug are not eligible
- Anti-cancer agents: patients who are currently receiving other anti-cancer agents are not eligible
- Anti-GVHD agents post-transplant: 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
- CYP3A/CYP3A4 agents: patients who are currently receiving drugs that are strong and moderate inducers or inhibitors of CYP3A or CYP3A4 are not eligible; strong inducers or inhibitors of CYP3A4 should be avoided from 21 days prior to enrollment to the end of the study
- Patients who have received a prior solid organ transplantation are not eligible
- Patients with symptomatic uncontrolled brain metastases; a scan to confirm the absence of brain metastases is not required; the patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to enrollment; patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days
- Major surgery must not have occurred within 2 weeks prior to enrollment and patients must have recovered from any effects of any major surgery
Other illness
- Patients who have an uncontrolled infection are not eligible
- Patient who are known to be serologically positive for human immunodeficiency virus (HIV)
- Patients with known active hepatitis (i.e. hepatitis B or C)
- Patients with known symptomatic Fanconi anemia (FA), ataxia-telangiectasia (A-T) syndrome, Bloom syndrome (BS) and Nijmegen breakage syndrome (NBS) are not eligible (asymptomatic carriers are acceptable)
Other
- 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; women of child-bearing potential and their partners should agree to use two (2) highly effective forms of contraception throughout study participation and for at least one (1) month after the last dose of olaparib; male study participants should avoid fathering a child or donating sperm during the study and for three (3) months after the last dose of olaparib
- 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
Who the study is looking for
- Patient must have enrolled onto APEC1621SC (NCT03155620) and must have been given a treatment assignment to Molecular Analysis for Therapy Choice (MATCH) to APEC1621H based on the presence of an actionable mutation
- Patients must be \>= than 12 months and =\< 21 years of age at the time of study enrollment
- Patients must have a body surface area \>= 0.65 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 iobenguane (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice
- 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 cerebrospinal 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, 131iodine \[I\]-MIBG): \>= 42 days after systemically administered radiopharmaceutical therapy
- Patients must not have received prior exposure to olaparib, veliparib, niraparib, rucaparib, talazoparib or other poly adenosine diphosphate ribose polymerase inhibitors (PARPi)
- For patients with solid tumors without known bone marrow involvement: peripheral absolute neutrophil count (ANC) \>= 1000/mm\^3 (within 7 days prior to enrollment)
- For patients with solid tumors without known bone marrow involvement: platelet count \>= 100,000/mm\^3 (within 7 days prior to enrollment) (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 platelet or packed red blood cells \[pRBC\] 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 1 to \< 2 years: maximum serum creatinine 0.6 mg/dL for male and 0.6 mg/dL for female
- Age 2 to \< 6 years: maximum serum creatinine 0.8 mg/dL for male and 0.8 mg/dL for female
- Age 6 to \< 10 years: maximum serum creatinine 1 mg/dL for male and 1 mg/dL for female
- Age 10 to \< 13 years: maximum serum creatinine 1.2 mg/dL for male and 1.2 mg/dL for female
- Age 13 to \< 16 years: maximum serum creatinine 1.5 mg/dL for male and 1.4 mg/dL for female
- Age \>= 16 years: maximum serum creatinine 1.7 mg/dL for male and 1.4 mg/dL for female
- Patients with solid tumors: bilirubin (sum of conjugated + unconjugated) =\< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
- Patients with solid tumors: serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L (within 7 days prior to enrollment); (for the purpose of this study, the ULN for SGPT is 45 U/L)
- Patients with solid tumors: serum albumin \>= 2 g/dL (within 7 days prior to enrollment)
- Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN (within 7 days prior to enrollment)
- International normalized ratio (INR) =\< 1.5 (within 7 days prior to enrollment)
- Patients must be able to swallow intact tablets
- 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
Age in the registry: 12 months to 21 years · Sex: All · Does not accept healthy volunteers
Sites (113)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| San Jorge Children's Hospital Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| University Pediatric Hospital Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Albany Medical Center Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Providence Alaska Medical Center Coordinator of this site? Confirm its status | Anchorage | United States | Unknown status |
| C S Mott Children's Hospital Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Mission Hospital Coordinator of this site? Confirm its status | Asheville | United States | Unknown status |
| Children's Healthcare of Atlanta-Egleston Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Dell Children's Medical Center of Central Texas Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Johns Hopkins University/Sidney Kimmel Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Sinai Hospital of Baltimore Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Eastern Maine Medical Center Coordinator of this site? Confirm its status | Bangor | United States | Unknown status |
| Children's Hospital of Alabama Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Saint Luke's Cancer Institute - Boise Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| University of Vermont and State Agricultural College Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
| Carolinas Medical Center/Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Novant Health Presbyterian Medical Center Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| University of Chicago Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Illinois Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Prisma Health Richland Hospital Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| UT Southwestern/Simmons Cancer Center-Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Medical City Dallas Hospital Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Geisinger Medical Center Coordinator of this site? Confirm its status | Danville | United States | Unknown status |
| Dayton Children's Hospital Coordinator of this site? Confirm its status | Dayton | United States | Unknown status |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Blank Children's Hospital Coordinator of this site? Confirm its status | Des Moines | United States | Unknown status |
| Kaiser Permanente Downey Medical Center Coordinator of this site? Confirm its status | Downey | United States | Unknown status |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Sanford Broadway Medical Center Coordinator of this site? Confirm its status | Fargo | United States | Unknown status |
| Cook Children's Medical Center Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| University of Florida Health Science Center - Gainesville Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| BI-LO Charities Children's Cancer Center Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Riley Hospital for Children Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of Iowa/Holden Comprehensive Cancer Center Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| University of Mississippi Medical Center Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| Nemours Children's Clinic-Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Bronson Methodist Hospital Coordinator of this site? Confirm its status | Kalamazoo | United States | Unknown status |
| Children's Mercy Hospitals and Clinics Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| East Tennessee Childrens Hospital Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Summerlin Hospital Medical Center Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| University Medical Center of Southern Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Arkansas Children's Hospital Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Loma Linda University Medical Center Coordinator of this site? Confirm its status | Loma Linda | United States | Unknown status |
| Miller Children's and Women's Hospital Long Beach Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Children's Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Norton Children's Hospital Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Valley Children's Hospital Coordinator of this site? Confirm its status | Madera | United States | Unknown status |
| University of Wisconsin Carbone Cancer Center - University Hospital Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Saint Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Banner Children's at Desert Coordinator of this site? Confirm its status | Mesa | United States | Unknown status |
| Nicklaus Children's Hospital Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Children's Hospital of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| NYU Langone Hospital - Long Island Coordinator of this site? Confirm its status | Mineola | United States | Unknown status |
| University of Minnesota/Masonic Cancer Center Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| West Virginia University Healthcare Coordinator of this site? Confirm its status | Morgantown | United States | Unknown status |
| Morristown Medical Center Coordinator of this site? Confirm its status | Morristown | United States | Unknown status |
| Vanderbilt University/Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| The Steven and Alexandra Cohen Children's Medical Center of New York Coordinator of this site? Confirm its status | New Hyde Park | United States | Unknown status |
| Ochsner Medical Center Jefferson Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Children's Hospital New Orleans Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| NYP/Weill Cornell Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Children's Hospital of The King's Daughters Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Kaiser Permanente-Oakland Coordinator of this site? Confirm its status | Oakland | United States | Unknown status |
| UCSF Benioff Children's Hospital Oakland Coordinator of this site? Confirm its status | Oakland | United States | Unknown status |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Children's Hospital and Medical Center of Omaha Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Arnold Palmer Hospital for Children Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| AdventHealth Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Nemours Children's Hospital Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Nemours Children's Clinic - Pensacola Coordinator of this site? Confirm its status | Pensacola | United States | Unknown status |
| Saint Jude Midwest Affiliate Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Children's Hospital of Pittsburgh of UPMC Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Legacy Emanuel Children's Hospital Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Virginia Commonwealth University/Massey Cancer Center Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Primary Children's Hospital Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Children's Hospital of San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Methodist Children's Hospital of South Texas Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| UCSF Medical Center-Mission Bay Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Sanford USD Medical Center - Sioux Falls Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Providence Sacred Heart Medical Center and Children's Hospital Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Southern Illinois University School of Medicine Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Cardinal Glennon Children's Medical Center Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Mercy Hospital Saint Louis Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| State University of New York Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Unknown status |
| Madigan Army Medical Center Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| Saint Joseph's Hospital/Children's Hospital-Tampa Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Scott and White Memorial Hospital Coordinator of this site? Confirm its status | Temple | United States | Unknown status |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
| Banner University Medical Center - Tucson Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| New York Medical College Coordinator of this site? Confirm its status | Valhalla | United States | Unknown status |
| Children's National Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Alfred I duPont Hospital for Children Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.