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Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03919071
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This phase II trial studies how well the combination of dabrafenib and trametinib works after radiation therapy in children and young adults with high grade glioma who have a genetic change called BRAF V600 mutation. Radiation therapy uses high energy rays to kill tumor cells and reduce the size of tumors. Dabrafenib and trametinib may stop the growth of tumor cells by blocking BRAF and MEK, respectively, which are enzymes that tumor cells need for their growth. Giving dabrafenib with trametinib after radiation therapy may work better than treatments used in the past in patients with newly-diagnosed BRAF V600-mutant high-grade glioma.

Condition or disease Intervention/treatment Phase
Anaplastic Astrocytoma Anaplastic Ganglioglioma Anaplastic Pleomorphic Xanthoastrocytoma Glioblastoma Malignant Glioma WHO Grade III Glioma Drug: Dabrafenib Drug: Dabrafenib Mesylate Radiation: Radiation Therapy Drug: Trametinib Drug: Trametinib Dimethyl Sulfoxide Phase 2

Detailed Description:

PRIMARY OBJECTIVE:

I. To estimate the event-free survival (EFS) distribution for newly-diagnosed patients with BRAFV600-mutant high-grade glioma (HGG) without H3 K27M mutations excluding anaplastic pleomorphic xanthoastrocytoma (aPXA) and anaplastic ganglioglioma (aGG) treated with radiation therapy followed by a maintenance combination of dabrafenib mesylate (dabrafenib) and trametinib dimethyl sulfoxide (trametinib) and to compare this EFS to contemporary historical controls.

SECONDARY OBJECTIVES:

I. To describe the overall survival (OS) distribution for newly-diagnosed patients with BRAFV600-mutant HGG without H3 K27M mutations excluding aPXA and aGG treated with radiation therapy followed by a maintenance combination of dabrafenib and trametinib.

II. To describe the EFS and overall survival (OS) distribution for newly-diagnosed patients with BRAFV600E-mutant aPXA and aGG without H3 K27M mutations treated with radiation therapy followed by a maintenance combination of dabrafenib and trametinib.

III. To define and evaluate the toxicities of combination therapy with dabrafenib and trametinib after radiation therapy in newly-diagnosed patients with HGG.

EXPLORATORY OBJECTIVE:

I. To bank tumor specimens and body fluids (blood, urine and cerebrospinal fluid) for future studies.

OUTLINE:

Patients undergo standardized local radiation therapy (RT) 5 days a week (Monday-Friday) for 6-7 weeks. Four weeks after completion of RT, patients receive dabrafenib mesylate orally (PO) twice daily (BID) and trametinib dimethyl sulfoxide PO once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at disease relapse, every 3 months for year 1, every 4 months for year 2, every 6 months for year 3, then annually for years 4-5.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Dabrafenib (NSC# 763760) With Trametinib (NSC# 763093) After Local Irradiation in Newly-Diagnosed BRAF V600-Mutant High-Grade Glioma (HGG)
Actual Study Start Date : October 2, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022


Arm Intervention/treatment
Experimental: Treatment (radiation therapy, dabrafenib, trametinib)
Patients undergo standardized local RT 5 days a week (Monday-Friday) for 6-7 weeks. Four weeks after completion of RT, patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO QD on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Drug: Dabrafenib
Given PO
Other Names:
  • BRAF Inhibitor GSK2118436
  • GSK-2118436
  • GSK-2118436A
  • GSK2118436

Drug: Dabrafenib Mesylate
Given PO
Other Names:
  • Dabrafenib Methanesulfonate
  • GSK2118436 Methane Sulfonate Salt
  • GSK2118436B
  • Tafinlar

Radiation: Radiation Therapy
Undergo RT
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • irradiated
  • Irradiation
  • RADIATION
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • RADIOTHERAPY
  • RT
  • Therapy, Radiation

Drug: Trametinib
Given PO
Other Names:
  • GSK1120212
  • JTP-74057
  • MEK Inhibitor GSK1120212
  • Mekinist

Drug: Trametinib Dimethyl Sulfoxide
Given PO




Primary Outcome Measures :
  1. Event-free survival (EFS) for stratum 1 [ Time Frame: From the date of diagnosis until disease progression date, secondary malignant neoplasm occurrence date, death date of any cause, or last follow-up, assessed up to 5 years ]
    The EFS curve for the new treatment cohort (Stratum 1) will be estimated by Kaplan Meier estimates. A 2-sample, 1 sided log-rank test will be used to test whether the EFS distribution is better in new treatment compared with historical control. Calculation of the EFS will be based on the site determination as central review will be performed retrospectively.


Secondary Outcome Measures :
  1. Overall survival (OS) for stratum 1 and stratum 2 [ Time Frame: From the date of diagnosis until death date of any cause or last follow up date, assessed up to 5 years ]
    The OS curve for the new treatment cohort (Stratum 1) will be estimated by Kaplan Meier estimates. A 2-sample, 1 sided log-rank test will be used to test whether the OS distribution is better in new treatment compared with historical control. For Stratum 2, Kaplan Meier estimates will be provided for OS distribution.

  2. Event-free survival (EFS) for stratum 2 [ Time Frame: Follow up date, assessed up to 5 years ]
    For Stratum 2, Kaplan Meier estimates will be provided for EFS distribution .

  3. Incidence of adverse events [ Time Frame: Up to 5 years ]
    Graded per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Grade 3 and higher toxicities observed by cycle will be listed for each stratum separately. The grade 3 and higher toxicities observed by cycle and by system organ class for the eligible patients will also be listed for each stratum separately. Toxicity data will be reported separately for the radiation therapy phase versus the maintenance therapy phase for clarity of attribution. Toxicity monitoring will include toxicities such as grade 2 or higher pyrexia, uveitis, retinal vein occlusion, retinal pigment epithelial detachment, and decreased left ventricular ejection fraction.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PRE-ENROLLMENT ELIGIBILITY SCREENING (STEP 0): Patient is suspected of having localized newly-diagnosed HGG, excluding intrinsic brainstem or spinal cord tumors, excluding metastatic disease
  • PRE-ENROLLMENT ELIGIBILITY SCREENING (STEP 0): Patient and/or their parents or legal guardians have signed informed consent for eligibility screening on APEC14B1 Part A.
  • PRE-ENROLLMENT ELIGIBILITY SCREENING (STEP 0): Specimens obtained at the time of diagnostic biopsy must be submitted through APEC14B1 as soon as possible (ASAP), preferably within 13 calendar days of definitive surgery.
  • Patients must be >= 3 years and =< 21 years of age at the time of enrollment
  • Patients must have eligibility confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1

    • Newly diagnosed high-grade glioma with BRAFV600-mutation
    • Negative results for H3 K27M by immunohistochemistry (IHC)
    • Histologically confirmed high-grade glioma (World Health Organization [WHO] grade III or IV) including but not limited to: anaplastic astrocytoma (AA), anaplastic pleomorphic xanthoastrocytoma (aPXA), anaplastic gangliogliomas (aGG), glioblastoma (GB), and high-grade astrocytoma, not otherwise specified (NOS)
  • Patients must have had histologic verification of a high-grade glioma diagnosis. Cerebrospinal fluid (CSF) cytology by lumbar puncture must be done if clinically indicated and determined to be safe prior to study enrollment. If cytology proves positive, the patient would be considered to have metastatic disease and would, therefore, be ineligible.
  • A pre- and post-operative brain magnetic resonance imaging (MRI) with and without contrast and a baseline spine MRI with contrast must be obtained prior to enrollment. The requirement for a post-operative MRI is waived for patients who undergo biopsy only. If the spine MRI is positive, the patient would be considered to have metastatic disease and would be ineligible.
  • 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.
  • Peripheral absolute neutrophil count (ANC) >= 1000/uL (within 7 days prior to enrollment).
  • Platelet count >= 100,000/uL (transfusion independent) (within 7 days prior to enrollment).
  • Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) (within 7 days prior to enrollment).
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 (within 7 days prior to enrollment) or
  • Serum creatinine based on age/gender as follows (within 7 days prior to enrollment):

    • Age 3 to < 6 years (Male 0.8 mg/dL, Female 0.8 mg/dL)
    • Age 6 to < 10 years (Male 1 mg/dL, Female 1 mg/dL)
    • Age 10 to < 13 years (Male 1.2 mg/dL, Female 1.2 mg/dL)
    • Age 13 to 16 < years (Male 1.5 mg/dL, Female 1.4 mg/dL)
    • Age >= 16 years (Male 1.7 mg/dL, Female 1.4 mg/dL)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment), and
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x upper limit of normal (ULN) for age (within 7 days prior to enrollment). For the purpose of this study, the ULN for SGPT is 45 U/L.
  • Patients with a seizure disorder may be enrolled if their seizures are well controlled while on non-enzyme inducing anticonvulsants permitted on this study.
  • Patients must be enrolled and protocol therapy must be projected to begin no later than 31 days after definitive diagnostic surgery (day 0). For patients who have a biopsy followed by resection, the date of resection will be considered the date of definitive diagnostic surgery. If a biopsy only was performed, the biopsy date will be considered the date of definitive diagnostic surgery.
  • 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.

Exclusion Criteria:

  • Patients with intrinsic brainstem or primary spinal cord tumors will be excluded.
  • Patients with metastatic disease (defined as neuraxis dissemination either by imaging or by cytology) will be excluded.
  • Patients must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant for the treatment of HGG other than surgical intervention and/or corticosteroids.
  • Previous treatment with dabrafenib or another RAF inhibitor, trametinib or another MEK inhibitor, or an ERK inhibitor.
  • Patients with a history of a malignancy with confirmed activating RAS mutation.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to dabrafenib, trametinib, and their excipients.
  • Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, liver disease, or uncontrolled infection), psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol.
  • Presence of active gastrointestinal (GI) disease or other condition (e.g., small bowel or large bowel resection) that will interfere significantly with the absorption of drugs.
  • History of hepatitis B virus, or hepatitis C virus infection (patients with laboratory evidence of cleared hepatitis B virus and/or hepatitis C virus may be enrolled).
  • History or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the study such as uncontrolled or significant cardiac disease, including any of the following:

    • Recent myocardial infarction (within the last 6 months);
    • Uncontrolled congestive heart failure;
    • Unstable angina (within last 6 months);
    • Clinically significant (symptomatic) or known, uncontrolled cardiac arrhythmias (e.g., sustained ventricular tachycardia, and clinically significant second or third degree atrioventricular [AV] block without a pacemaker) except sinus arrhythmia within the past 24 weeks prior to the first dose of study treatment;
    • Coronary angioplasty or stenting (within last 6 months);
    • Intra-cardiac defibrillators;
    • Abnormal cardiac valve morphology (>= grade 2) documented by echocardiogram.
  • Patients with a history or current evidence of retinal vein occlusion (RVO) or central serous retinopathy (CSR), or predisposing factors to RVO or CSR (e.g., uncontrolled glaucoma or ocular hypertension).
  • Patients with presence of interstitial lung disease or pneumonitis.
  • Female patients who are pregnant are ineligible since there is yet no available information regarding human fetal or teratogenic toxicities.
  • Lactating females are not eligible unless they have agreed not to breastfeed their infants for the duration of the study and for 4 months following discontinuation of study therapy.
  • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained.
  • Sexually active patients of reproductive potential (male or female) are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation and for 4 months following discontinuation of study therapy. Male patients (including those who have had a vasectomy) taking dabrafenib and trametinib combination therapy must use a condom during intercourse while on study and for 16 weeks after stopping treatment, and should not father a child during these periods. Women of childbearing potential should use effective non-hormonal contraception during therapy and for 4 weeks following discontinuation of dabrafenib and at least 4 months following the last dose of trametinib in patients taking combination therapy. Women should be advised that dabrafenib may decrease the efficacy of hormonal contraceptives and an alternate method of contraception, such as barrier methods, should be used.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919071


Locations
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United States, Alabama
Children's Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Site Public Contact    205-638-9285    oncologyresearch@peds.uab.edu   
Principal Investigator: Matthew A. Kutny         
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202-3591
Contact: Site Public Contact    501-364-7373      
Principal Investigator: David L. Becton         
United States, California
Kaiser Permanente Downey Medical Center Recruiting
Downey, California, United States, 90242
Contact: Site Public Contact    626-564-3455      
Principal Investigator: Robert M. Cooper         
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Site Public Contact    323-361-4110      
Principal Investigator: Nathan J. Robison         
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Site Public Contact    310-423-8965      
Principal Investigator: Fataneh (Fae) Majlessipour         
Kaiser Permanente-Oakland Recruiting
Oakland, California, United States, 94611
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Laura A. Campbell         
University of California Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Site Public Contact    916-734-3089      
Principal Investigator: Marcio H. Malogolowkin         
UCSF Medical Center-Mission Bay Recruiting
San Francisco, California, United States, 94158
Contact: Site Public Contact    877-827-3222      
Principal Investigator: Alyssa T. Reddy         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Site Public Contact    303-764-5056    josh.b.gordon@nsmtp.kp.org   
Principal Investigator: Kathleen M. Dorris         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Site Public Contact    860-545-9981      
Principal Investigator: Michael S. Isakoff         
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Site Public Contact    203-785-5702    canceranswers@yale.edu   
Principal Investigator: Nina S. Kadan-Lottick         
United States, Florida
Golisano Children's Hospital of Southwest Florida Recruiting
Fort Myers, Florida, United States, 33908
Contact: Site Public Contact    239-343-5333    molly.arnstrom@leehealth.org   
Principal Investigator: Emad K. Salman         
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Site Public Contact    954-265-1847    OHR@mhs.net   
Principal Investigator: Iftikhar Hanif         
University of Miami Miller School of Medicine-Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Site Public Contact    305-243-2647      
Principal Investigator: Julio C. Barredo         
AdventHealth Orlando Recruiting
Orlando, Florida, United States, 32803
Contact: Site Public Contact    407-303-2090    FH.Cancer.Research@flhosp.org   
Principal Investigator: Fouad M. Hajjar         
Saint Joseph's Hospital/Children's Hospital-Tampa Recruiting
Tampa, Florida, United States, 33607
Contact: Site Public Contact    813-356-7168    Katelynn.Colgain@baycare.org   
Principal Investigator: Don E. Eslin         
Saint Mary's Hospital Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Site Public Contact    561-881-2815      
Principal Investigator: Narayana Gowda         
United States, Georgia
Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31404
Contact: Site Public Contact    912-350-7887    clayter1@memorialhealth.com   
Principal Investigator: Andrew L. Pendleton         
United States, Hawaii
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Site Public Contact    808-983-6090      
Principal Investigator: Wade T. Kyono         
United States, Illinois
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Site Public Contact    773-702-8222    cancerclinicaltrials@bsd.uchicago.edu   
Principal Investigator: Wendy S. Darlington         
Saint Jude Midwest Affiliate Recruiting
Peoria, Illinois, United States, 61637
Contact: Site Public Contact    888-226-4343      
Principal Investigator: Jaime M. Libes         
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Site Public Contact    800-248-1199      
Principal Investigator: Sandeep Batra         
Saint Vincent Hospital and Health Care Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Site Public Contact    317-338-2194    research@stvincent.org   
Principal Investigator: Jessica F. Goodman         
United States, Maine
Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Contact: Site Public Contact    207-973-4274      
Principal Investigator: Nadine P. SantaCruz         
United States, Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Site Public Contact    410-955-8804    jhcccro@jhmi.edu   
Principal Investigator: Kenneth J. Cohen         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Site Public Contact    877-442-3324      
Principal Investigator: Susan N. Chi         
United States, Michigan
C S Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Site Public Contact    800-865-1125      
Principal Investigator: Carl J. Koschmann         
Helen DeVos Children's Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Site Public Contact    612-813-5193      
Principal Investigator: Michael K. Richards         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Site Public Contact    855-776-0015      
Principal Investigator: Jonathan D. Schwartz         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Site Public Contact    601-815-6700      
Principal Investigator: Anderson (Andy) B. Collier         
United States, Missouri
Cardinal Glennon Children's Medical Center Recruiting
Saint Louis, Missouri, United States, 63104
Contact: Site Public Contact    314-268-4000      
Principal Investigator: William S. Ferguson         
United States, Nebraska
Children's Hospital and Medical Center of Omaha Recruiting
Omaha, Nebraska, United States, 68114
Contact: Site Public Contact    402-955-3949      
Principal Investigator: Minnie Abromowitch         
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Site Public Contact    402-559-6941    unmcrsa@unmc.edu   
Principal Investigator: Minnie Abromowitch         
United States, New Jersey
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Site Public Contact    973-971-5900      
Principal Investigator: John J. Gregory         
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Site Public Contact    518-262-5513      
Principal Investigator: Lauren R. Weintraub         
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center Recruiting
New York, New York, United States, 10032
Contact: Site Public Contact    212-305-6361    nr2616@cumc.columbia.edu   
Principal Investigator: Alice Lee         
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Site Public Contact    315-464-5476      
Principal Investigator: Philip M. Monteleone         
United States, Ohio
Children's Hospital Medical Center of Akron Recruiting
Akron, Ohio, United States, 44308
Contact: Site Public Contact    330-543-3193      
Principal Investigator: Steven J. Kuerbitz         
Rainbow Babies and Childrens Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Site Public Contact    216-844-5437      
Principal Investigator: Duncan S. Stearns         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Site Public Contact    866-223-8100    CancerAnswer@ccf.org   
Principal Investigator: Rabi Hanna         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Site Public Contact    405-271-8777    ou-clinical-trials@ouhsc.edu   
Principal Investigator: Rene Y. McNall-Knapp         
United States, Oregon
Legacy Emanuel Children's Hospital Recruiting
Portland, Oregon, United States, 97227
Contact: Site Public Contact    503-413-2560      
Principal Investigator: Janice F. Olson         
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Site Public Contact    503-494-1080    trials@ohsu.edu   
Principal Investigator: Kellie J. Nazemi         
United States, Pennsylvania
Lehigh Valley Hospital-Cedar Crest Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Felipe S. Bautista-Otanez         
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Site Public Contact    267-425-5544    CancerTrials@email.chop.edu   
Principal Investigator: Jane E. Minturn         
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Site Public Contact    412-692-8570    jean.tersak@chp.edu   
Principal Investigator: James T. Felker         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Site Public Contact    401-444-1488      
Principal Investigator: Jennifer J. Greene Welch         
United States, South Carolina
Prisma Health Richland Hospital Recruiting
Columbia, South Carolina, United States, 29203
Contact: Site Public Contact    803-434-3533      
Principal Investigator: Stuart L. Cramer         
BI-LO Charities Children's Cancer Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Site Public Contact    864-522-2066    kim.williams3@prismahealth.org   
Principal Investigator: Nichole L. Bryant         
United States, Tennessee
East Tennessee Childrens Hospital Recruiting
Knoxville, Tennessee, United States, 37916
Contact: Site Public Contact    865-541-8266      
Principal Investigator: Ray C. Pais         
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Site Public Contact    866-278-5833    info@stjude.org   
Principal Investigator: Santhosh A. Upadhyaya         
United States, Texas
UT Southwestern/Simmons Cancer Center-Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Site Public Contact    214-648-7097    canceranswerline@UTSouthwestern.edu   
Principal Investigator: Daniel C. Bowers         
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Site Public Contact    713-798-1354    burton@bcm.edu   
Principal Investigator: Patricia A. Baxter         
Children's Hospital of San Antonio Recruiting
San Antonio, Texas, United States, 78207
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Timothy C. Griffin         
Scott and White Memorial Hospital Recruiting
Temple, Texas, United States, 76508
Contact: Site Public Contact    254-724-5407      
Principal Investigator: Nicholas W. McGregor         
United States, Utah
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Site Public Contact    801-585-5270      
Principal Investigator: Phillip E. Barnette         
United States, Virginia
Children's Hospital of The King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Site Public Contact    757-668-7243    CCBDCresearch@chkd.org   
Principal Investigator: Eric J. Lowe         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Site Public Contact    866-987-2000      
Principal Investigator: Douglas S. Hawkins         
Providence Sacred Heart Medical Center and Children's Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Site Public Contact    800-228-6618    HopeBeginsHere@providence.org   
Principal Investigator: Judy L. Felgenhauer         
United States, Wisconsin
Marshfield Medical Center-Marshfield Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Michelle A. Manalang         
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Rishi R Lulla Children's Oncology Group

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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03919071    
Other Study ID Numbers: NCI-2019-02289
NCI-2019-02289 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ACNS1723 ( Other Identifier: Childrens Oncology Group )
ACNS1723 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
URL: https://grants.nih.gov/policy/sharing.htm

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioblastoma
Glioma
Astrocytoma
Ganglioglioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Trametinib
Dabrafenib
Dimethyl Sulfoxide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Free Radical Scavengers
Antioxidants