Selpercatinib for the Treatment of Advanced Solid Tumors, Lymphomas, or Histiocytic Disorders With Activating RET Gene Alterations, a Pediatric MATCH Treatment Trial

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT04320888
Collaborator
Children's Oncology Group (Other)
49
172
1
84.5
0.3
0

Study Details

Study Description

Brief Summary

This phase II pediatric MATCH trial studies how well selpercatinib works in treating patients with solid tumors that have spread to other places in the body (advanced), lymphomas, or histiocytic disorders that have activating RET gene alterations. Selpercatinib may block the growth of cancer cells that have specific genetic changes in an important signaling pathway (called the RET pathway) and may reduce tumor size.

Detailed Description

PRIMARY OBJECTIVE:
  1. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with selpercatinib (LOXO-292) with advanced solid tumors (including central nervous system [CNS] tumors), lymphomas or histiocytic disorders that harbor activating genetic alterations in the RET pathway.
SECONDARY OBJECTIVES:
  1. To estimate the progression free survival in pediatric patients treated with selpercatinib (LOXO-292) with advanced solid tumors (including CNS tumors), lymphomas or histiocytic disorders that harbor activating genetic alterations in the RET pathway.

  2. To obtain information about the tolerability of selpercatinib (LOXO-292) in children and adolescents with relapsed or refractory cancer.

EXPLORATORY OBJECTIVE:
  1. To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA).
OUTLINE:

Patients receive selpercatinib orally (PO) twice daily (BID) on days 1-28. 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 for 30 days, then periodically thereafter.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
49 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of LOXO-292 in Patients With Tumors Harboring RET Gene Alterations
Actual Study Start Date :
Sep 14, 2020
Anticipated Primary Completion Date :
Sep 30, 2027
Anticipated Study Completion Date :
Sep 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (selpercatinib)

Patients receive selpercatinib PO BID on days 1-28. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.

Drug: Selpercatinib
Given PO
Other Names:
  • LOXO-292
  • RET Kinase Inhibitor LOXO-292
  • Retevmo
  • WHO 10967
  • Outcome Measures

    Primary Outcome Measures

    1. Objective response rate (complete response + partial response) in pediatric patients treated with selpercatinib (LOXO-292) [Up to 2 years]

      Will be determined by Response Evaluation Criteria in Solid Tumors. 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.

    Secondary Outcome Measures

    1. Progression-free survival (PFS) [From the initiation of subprotocol (APEC1621N) treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 2 years]

      PFS along with the confidence intervals will be estimated using the Kaplan-Meier method.

    2. Percentage of patients experiencing grade 3 or 4 adverse events [Up to 2 years]

      Evaluated by Common Terminology Criteria for Adverse Events version 5. Any eligible patient who receives at least one dose of protocol therapy will be considered in the evaluation of toxicity.

    Other Outcome Measures

    1. Profiling changes in tumor genomics [Up to time of disease progression or end of protocol therapy]

      Will explore approaches to the profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid. A descriptive analysis will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Months to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to MATCH to APEC1621N based on the presence of an actionable mutation

    • 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 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 [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 radiopharmaceutical therapy

    • Patients must not have received prior exposure to LOXO-292 or other specific RET inhibitors

    • 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. (within 7 days prior to enrollment) (For the purpose of this study, the ULN for SGPT is 45 U/L.)

    • Serum albumin >= 2 g/dL (within 7 days prior to enrollment)

    • Corrected QT (QTc) interval =< 480 milliseconds (within 7 days prior to enrollment)

    • 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 (2) highly effective contraceptive method for the duration of study treatment and for at least 2 weeks after the last dose of selpercatinib (LOXO-292). Male study participants are to refrain from sperm donation during treatment and for 2 weeks after the last dose of selpercatinib (LOXO-292)

    • 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 moderate or strong inducers or inhibitors of CYP3A4 are not eligible. Strong inducers or inhibitors of CYP3A4 should be avoided from 14 days prior to enrollment to the end of the study. Note: CYP3A4 inducing anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed

    • Proton pump inhibitors (PPIs), H2 receptor antagonists and antacids: Concomitant use of PPIs during selpercatinib (LOXO-292) therapy should be avoided if feasible. If co-administration of selpercatinib and PPI is necessary, administer selpercatinib with a meal. If H2 receptor antagonist is necessary, administer selpercatinib 2 hours before or 10 hours after H2 receptor antagonist administration. If antacid use is necessary, administer selpercatinib 2 or more hours before or 2 or more hours after antacid administration

    • Patients who have major surgery within 14 days prior to cycle 1 day 1 (C1D1) are not eligible. (Central line placement or subcutaneous port placement is not considered major surgery)

    • Patients with known clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of selpercatinib (LOXO-292) are excluded

    • Patients with known hypersensitivity to any of the components of the investigational agent, LOXO 292 are excluded

    • Patients with uncontrolled hypertension are excluded

    • Patients with uncontrolled symptomatic hyperthyroidism and hypothyroidism (i.e. the patient required a modification to current thyroid medication in 7 days prior to enrollment) are excluded

    • Patients with uncontrolled symptomatic hypercalcemia and hypocalcemia are excluded

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Alabama Birmingham Alabama United States 35233
    2 Providence Alaska Medical Center Anchorage Alaska United States 99508
    3 Banner Children's at Desert Mesa Arizona United States 85202
    4 Phoenix Childrens Hospital Phoenix Arizona United States 85016
    5 Banner University Medical Center - Tucson Tucson Arizona United States 85719
    6 Arkansas Children's Hospital Little Rock Arkansas United States 72202-3591
    7 Kaiser Permanente Downey Medical Center Downey California United States 90242
    8 City of Hope Comprehensive Cancer Center Duarte California United States 91010
    9 Loma Linda University Medical Center Loma Linda California United States 92354
    10 Miller Children's and Women's Hospital Long Beach Long Beach California United States 90806
    11 Children's Hospital Los Angeles Los Angeles California United States 90027
    12 Cedars Sinai Medical Center Los Angeles California United States 90048
    13 Mattel Children's Hospital UCLA Los Angeles California United States 90095
    14 Valley Children's Hospital Madera California United States 93636
    15 UCSF Benioff Children's Hospital Oakland Oakland California United States 94609
    16 Kaiser Permanente-Oakland Oakland California United States 94611
    17 Children's Hospital of Orange County Orange California United States 92868
    18 Lucile Packard Children's Hospital Stanford University Palo Alto California United States 94304
    19 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    20 Rady Children's Hospital - San Diego San Diego California United States 92123
    21 Naval Medical Center -San Diego San Diego California United States 92134
    22 UCSF Medical Center-Mission Bay San Francisco California United States 94158
    23 Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California United States 90502
    24 Children's Hospital Colorado Aurora Colorado United States 80045
    25 Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado United States 80218
    26 Connecticut Children's Medical Center Hartford Connecticut United States 06106
    27 Yale University New Haven Connecticut United States 06520
    28 Alfred I duPont Hospital for Children Wilmington Delaware United States 19803
    29 MedStar Georgetown University Hospital Washington District of Columbia United States 20007
    30 Children's National Medical Center Washington District of Columbia United States 20010
    31 Broward Health Medical Center Fort Lauderdale Florida United States 33316
    32 Golisano Children's Hospital of Southwest Florida Fort Myers Florida United States 33908
    33 University of Florida Health Science Center - Gainesville Gainesville Florida United States 32610
    34 Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida United States 33021
    35 Nemours Children's Clinic-Jacksonville Jacksonville Florida United States 32207
    36 University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida United States 33136
    37 Nicklaus Children's Hospital Miami Florida United States 33155
    38 Miami Cancer Institute Miami Florida United States 33176
    39 AdventHealth Orlando Orlando Florida United States 32803
    40 Arnold Palmer Hospital for Children Orlando Florida United States 32806
    41 Nemours Children's Hospital Orlando Florida United States 32827
    42 Sacred Heart Hospital Pensacola Florida United States 32504
    43 Johns Hopkins All Children's Hospital Saint Petersburg Florida United States 33701
    44 Tampa General Hospital Tampa Florida United States 33606
    45 Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida United States 33607
    46 Saint Mary's Hospital West Palm Beach Florida United States 33407
    47 Children's Healthcare of Atlanta - Egleston Atlanta Georgia United States 30322
    48 Memorial Health University Medical Center Savannah Georgia United States 31404
    49 Kapiolani Medical Center for Women and Children Honolulu Hawaii United States 96826
    50 Saint Luke's Cancer Institute - Boise Boise Idaho United States 83712
    51 Lurie Children's Hospital-Chicago Chicago Illinois United States 60611
    52 University of Illinois Chicago Illinois United States 60612
    53 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
    54 Loyola University Medical Center Maywood Illinois United States 60153
    55 Saint Jude Midwest Affiliate Peoria Illinois United States 61637
    56 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    57 Riley Hospital for Children Indianapolis Indiana United States 46202
    58 Saint Vincent Hospital and Health Care Center Indianapolis Indiana United States 46260
    59 Blank Children's Hospital Des Moines Iowa United States 50309
    60 University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa United States 52242
    61 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
    62 Norton Children's Hospital Louisville Kentucky United States 40202
    63 Children's Hospital New Orleans New Orleans Louisiana United States 70118
    64 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
    65 Eastern Maine Medical Center Bangor Maine United States 04401
    66 Maine Children's Cancer Program Scarborough Maine United States 04074
    67 University of Maryland/Greenebaum Cancer Center Baltimore Maryland United States 21201
    68 Sinai Hospital of Baltimore Baltimore Maryland United States 21215
    69 Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland United States 21287
    70 National Institutes of Health Clinical Center Bethesda Maryland United States 20892
    71 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    72 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    73 UMass Memorial Medical Center - University Campus Worcester Massachusetts United States 01655
    74 C S Mott Children's Hospital Ann Arbor Michigan United States 48109
    75 Wayne State University/Karmanos Cancer Institute Detroit Michigan United States 48201
    76 Michigan State University Clinical Center East Lansing Michigan United States 48824-7016
    77 Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan United States 49503
    78 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    79 Beaumont Children's Hospital-Royal Oak Royal Oak Michigan United States 48073
    80 Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota United States 55404
    81 University of Minnesota/Masonic Cancer Center Minneapolis Minnesota United States 55455
    82 Mayo Clinic in Rochester Rochester Minnesota United States 55905
    83 University of Mississippi Medical Center Jackson Mississippi United States 39216
    84 Children's Mercy Hospitals and Clinics Kansas City Missouri United States 64108
    85 Cardinal Glennon Children's Medical Center Saint Louis Missouri United States 63104
    86 Washington University School of Medicine Saint Louis Missouri United States 63110
    87 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    88 Children's Hospital and Medical Center of Omaha Omaha Nebraska United States 68114
    89 University of Nebraska Medical Center Omaha Nebraska United States 68198
    90 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
    91 Sunrise Hospital and Medical Center Las Vegas Nevada United States 89109
    92 Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada United States 89135
    93 Summerlin Hospital Medical Center Las Vegas Nevada United States 89144
    94 Renown Regional Medical Center Reno Nevada United States 89502
    95 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    96 Hackensack University Medical Center Hackensack New Jersey United States 07601
    97 Morristown Medical Center Morristown New Jersey United States 07960
    98 Saint Peter's University Hospital New Brunswick New Jersey United States 08901
    99 Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick New Jersey United States 08903
    100 Albany Medical Center Albany New York United States 12208
    101 Montefiore Medical Center - Moses Campus Bronx New York United States 10467
    102 Roswell Park Cancer Institute Buffalo New York United States 14263
    103 NYU Winthrop Hospital Mineola New York United States 11501
    104 The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park New York United States 11040
    105 Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York United States 10016
    106 NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    107 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    108 NYP/Weill Cornell Medical Center New York New York United States 10065
    109 University of Rochester Rochester New York United States 14642
    110 Stony Brook University Medical Center Stony Brook New York United States 11794
    111 State University of New York Upstate Medical University Syracuse New York United States 13210
    112 New York Medical College Valhalla New York United States 10595
    113 Mission Hospital Asheville North Carolina United States 28801
    114 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
    115 Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina United States 28203
    116 Novant Health Presbyterian Medical Center Charlotte North Carolina United States 28204
    117 Duke University Medical Center Durham North Carolina United States 27710
    118 East Carolina University Greenville North Carolina United States 27834
    119 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    120 Sanford Broadway Medical Center Fargo North Dakota United States 58122
    121 Children's Hospital Medical Center of Akron Akron Ohio United States 44308
    122 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
    123 Rainbow Babies and Childrens Hospital Cleveland Ohio United States 44106
    124 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    125 Nationwide Children's Hospital Columbus Ohio United States 43205
    126 Dayton Children's Hospital Dayton Ohio United States 45404
    127 ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio United States 43606
    128 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    129 Legacy Emanuel Children's Hospital Portland Oregon United States 97227
    130 Oregon Health and Science University Portland Oregon United States 97239
    131 Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania United States 18103
    132 Geisinger Medical Center Danville Pennsylvania United States 17822
    133 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    134 Saint Christopher's Hospital for Children Philadelphia Pennsylvania United States 19134
    135 Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania United States 15224
    136 Rhode Island Hospital Providence Rhode Island United States 02903
    137 Prisma Health Richland Hospital Columbia South Carolina United States 29203
    138 BI-LO Charities Children's Cancer Center Greenville South Carolina United States 29605
    139 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    140 T C Thompson Children's Hospital Chattanooga Tennessee United States 37403
    141 East Tennessee Childrens Hospital Knoxville Tennessee United States 37916
    142 Saint Jude Children's Research Hospital Memphis Tennessee United States 38105
    143 The Children's Hospital at TriStar Centennial Nashville Tennessee United States 37203
    144 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
    145 Dell Children's Medical Center of Central Texas Austin Texas United States 78723
    146 Driscoll Children's Hospital Corpus Christi Texas United States 78411
    147 Medical City Dallas Hospital Dallas Texas United States 75230
    148 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
    149 El Paso Children's Hospital El Paso Texas United States 79905
    150 Cook Children's Medical Center Fort Worth Texas United States 76104
    151 Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas United States 77030
    152 M D Anderson Cancer Center Houston Texas United States 77030
    153 Covenant Children's Hospital Lubbock Texas United States 79410
    154 UMC Cancer Center / UMC Health System Lubbock Texas United States 79415
    155 Children's Hospital of San Antonio San Antonio Texas United States 78207
    156 Methodist Children's Hospital of South Texas San Antonio Texas United States 78229
    157 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
    158 Scott and White Memorial Hospital Temple Texas United States 76508
    159 Primary Children's Hospital Salt Lake City Utah United States 84113
    160 University of Vermont and State Agricultural College Burlington Vermont United States 05405
    161 Children's Hospital of The King's Daughters Norfolk Virginia United States 23507
    162 Naval Medical Center - Portsmouth Portsmouth Virginia United States 23708-2197
    163 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298
    164 Seattle Children's Hospital Seattle Washington United States 98105
    165 Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington United States 99204
    166 Mary Bridge Children's Hospital and Health Center Tacoma Washington United States 98405
    167 Madigan Army Medical Center Tacoma Washington United States 98431
    168 West Virginia University Healthcare Morgantown West Virginia United States 26506
    169 University of Wisconsin Carbone Cancer Center Madison Wisconsin United States 53792
    170 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    171 Children's Hospital of Wisconsin Milwaukee Wisconsin United States 53226
    172 University Pediatric Hospital San Juan Puerto Rico 00926

    Sponsors and Collaborators

    • National Cancer Institute (NCI)
    • Children's Oncology Group

    Investigators

    • Principal Investigator: Andrea T Franson, Children's Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT04320888
    Other Study ID Numbers:
    • NCI-2020-01756
    • NCI-2020-01756
    • APEC1621N
    • APEC1621N
    • U10CA180886
    First Posted:
    Mar 25, 2020
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Apr 1, 2022

    Study Results

    No Results Posted as of Aug 25, 2022