Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01922076 : WEE1 Inhibitor AZD1775 and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas
PhasePhase 1
AgesMin: 37 Months Max: 21 Years
Eligibility
Inclusion Criteria:

- Patients with newly diagnosed DIPGs, defined as tumors with a pontine epicenter and
diffuse involvement of the pons, are eligible without histologic confirmation

- Patients with brainstem tumors that do not meet these criteria or are not
considered to be typical intrinsic pontine gliomas will only be eligible if the
tumors are biopsied and proven to be an anaplastic astrocytoma, glioblastoma,
gliosarcoma, diffuse midline glioma with histone H3 K27M mutation, or anaplastic
mixed glioma; patients with pilocytic astrocytoma, fibrillary astrocytoma,
gangliogliomas, or other mixed gliomas without anaplasia are not eligible

- Patients with disseminated disease are not eligible, and magnetic resonance
imaging (MRI) of spine must be performed if disseminated disease is suspected by
the treating physician

- Enrollment must be no later than 28 days after the date of radiographic diagnosis
or surgery, whichever is the later date

- Patients must have a body surface area >= 0.35 m^2 at the time of study enrollment

- Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16
years of age; 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 not have received any prior chemotherapy, radiation therapy,
immunotherapy or bone marrow transplant for the treatment of DIPG; prior dexamethasone
and/or surgery are allowed

- Peripheral absolute neutrophil count (ANC) >= 1000/mm^3

- Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving
platelet transfusions for at least 7 days prior to enrollment)

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 or

- A serum creatinine based on age/gender as follows:

- 0.8 mg/dL (3 to < 6 years of age)

- 1.0 mg/dL (6 to < 10 years of age)

- 1.2 mg/dL (10 to < 13 years of age)

- 1.5 mg/dL (male) or 1.4 mg/dl (female) (13 to < 16 years of age)

- 1.7 mg/dL (male) or 1.4 mg/dl (female) (>= 16 years of age)

- Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for
age

- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x
ULN = 135 units per liter (U/L); for the purpose of this study, the ULN for SGPT is 45
U/L

- Serum glutamic oxaloacetic transaminase (SGOT) aspartate aminotransferase [AST] =< 3 x
ULN = 150 U/L; for the purpose of this study, the ULN for SGOT is 50 U/L

- Serum albumin >= 2 g/dL

- Patients with seizure disorder may be enrolled if on non-enzyme inducing
anticonvulsants and well controlled

- Corrected QT interval (QTc) =< 480 msec

- 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 may not be entered on this study; pregnancy tests
must be obtained in girls who are post-menarchal; negative serum or urine pregnancy
test within 3 days prior to enrollment

- Males or females of reproductive potential may not participate unless they have agreed
to use an effective contraceptive methods as follows: fertile females of childbearing
potential who agree to use adequate contraceptive measures from 2 weeks prior to the
study and until 1 month after study treatment discontinuation; male patients willing
to abstain or use barrier contraception (i.e. condoms) for the duration of the study
and for 3 months after treatment stops

- Patients receiving corticosteroids are eligible for this trial

- Patients who are currently receiving another investigational drug are not eligible

- Patients who are currently receiving other anti-cancer agents are not eligible

- Patients must not currently be receiving enzyme inducing anticonvulsants

- Patients should avoid concomitant medication known or suspected to prolong QTc
interval or cause Torsades De Pointes; if possible, alternative agents should be
considered; patients who are receiving drugs that prolong the QTc are eligible if the
drug is necessary and no alternatives are available

- Patients who are currently receiving drugs that are strong or moderate inhibitors
and/or inducers of CYP3A4, sensitive CYP3A4 substrates and CYP3A4 substrates with a
narrow therapeutic range are not eligible; the use of aprepitant or fosaprepitant as
an antiemetic is prohibited due to early drug interaction data demonstrating increased
exposure to AZD1775; the use of hydroxymethylglutary (HMG) coenzyme-A (Co-A)
inhibitors such as atorvastatin is prohibited

- Herbal preparations are not allowed throughout the study; these herbal medications
include but are not limited to: St. John's wort, kava, ephedra (ma hung), gingko
biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto and ginseng; patients
should stop using these herbal medications 7 days prior to study enrollment

- Any known hypersensitivity or contraindication to the components of the study drug
AZD1775

- Patients must not receive metformin for at least 5 days prior to enrollment and for
the duration of study treatment

- Patients must be able to swallow capsules; nasogastric or gastrostomy feeding (G) tube
administration is not allowed

- Patients who have an uncontrolled infection are not eligible

- Patients who have received a prior solid organ transplantation are not eligible

- Patients with cardiac diseases ongoing or in the past 6 months (e.g. congestive heart
failure, acute myocardial infarction, significant uncontrolled arrhythmias) are not
eligible for this trial

- Major surgical procedures =< 28 days of beginning study treatment, or minor surgical
procedures (including ventriculoperitoneal [VP] shunt placement or stereotactic biopsy
of the tumor) =< 7 days; no waiting period required following port-a-cath or other
central venous access placement

- 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
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT01922076      |      Link to official Clinicaltrials.gov listing
Locations
Birmingham, Alabama
Facility: Children's Hospital of Alabama
Investigator: Alyssa T. Reddy
Contact: Alyssa T. Reddy Phone: 888-823-5923
Click HERE to send email to this center

Los Angeles, California
Facility: Children's Hospital Los Angeles
Investigator: Nathan J. Robison
Contact: Nathan J. Robison Phone: 877-442-3324
Email not avaialable

Orange, California
Facility: Children's Hospital of Orange County
Investigator: Ivan I. Kirov
Contact: Ivan I. Kirov Phone: 888-823-5923
Click HERE to send email to this center

Aurora, Colorado
Facility: Children's Hospital Colorado
Investigator: Margaret E. Macy
Contact: Margaret E. Macy Phone: 888-823-5923
Click HERE to send email to this center

Washington, D.C., District of Columbia
Facility: Children's National Medical Center
Investigator: AeRang Kim
Contact: AeRang Kim Phone: 800-411-1222
Email not avaialable

Atlanta, Georgia
Facility: Children's Healthcare of Atlanta - Egleston
Investigator: Tobey J. MacDonald
Contact: Tobey J. MacDonald Phone: 888-823-5923
Click HERE to send email to this center

Chicago, Illinois
Facility: Lurie Children's Hospital-Chicago
Investigator: Stewart Goldman
Contact: Stewart Goldman Phone: 888-823-5923
Click HERE to send email to this center

Indianapolis, Indiana
Facility: Riley Hospital for Children
Investigator: James M. Croop
Contact: James M. Croop Phone: 800-248-1199
Email not avaialable

Boston, Massachusetts
Facility: Dana-Farber Cancer Institute
Investigator: Steven G. DuBois
Contact: Steven G. DuBois Phone: 877-827-3222
Email not avaialable

Ann Arbor, Michigan
Facility: C S Mott Children's Hospital
Investigator: Patricia L. Robertson
Contact: Patricia L. Robertson Phone: 888-823-5923
Click HERE to send email to this center

Minneapolis, Minnesota
Facility: University of Minnesota/Masonic Cancer Center
Investigator: Emily G. Greengard
Contact: Emily G. Greengard Phone: 888-823-5923
Click HERE to send email to this center

Saint Louis, Missouri
Facility: Washington University School of Medicine
Investigator: Robert J. Hayashi
Contact: Robert J. Hayashi Phone: 800-600-3606
Click HERE to send email to this center

New York, New York
Facility: Columbia University/Herbert Irving Cancer Center
Investigator: Julia Glade-Bender
Contact: Julia Glade-Bender Phone: 212-305-8615
Email not avaialable

Cincinnati, Ohio
Facility: Cincinnati Children's Hospital Medical Center
Investigator: James I. Geller
Contact: James I. Geller Phone: 888-823-5923
Click HERE to send email to this center

Portland, Oregon
Facility: Oregon Health and Science University
Investigator: Suman Malempati
Contact: Suman Malempati Phone: 503-494-1080
Click HERE to send email to this center

Philadelphia, Pennsylvania
Facility: Children's Hospital of Philadelphia
Investigator: Elizabeth Fox
Contact: Elizabeth Fox Phone: 800-411-1222
Email not avaialable

Pittsburgh, Pennsylvania
Facility: Children's Hospital of Pittsburgh of UPMC
Investigator: Jean M. Tersak
Contact: Jean M. Tersak Phone: 888-823-5923
Click HERE to send email to this center

Memphis, Tennessee
Facility: St. Jude Children's Research Hospital
Investigator: Wayne L. Furman
Contact: Wayne L. Furman Phone: 888-823-5923
Click HERE to send email to this center

Houston, Texas
Facility: Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Investigator: Jodi Muscal
Contact: Jodi Muscal Phone: 713-798-1354
Click HERE to send email to this center

Seattle, Washington
Facility: Seattle Children's Hospital
Investigator: Julie R. Park
Contact: Julie R. Park Phone: 888-823-5923
Click HERE to send email to this center

Milwaukee, Wisconsin
Facility: Children's Hospital of Wisconsin
Investigator: Michael E. Kelly
Contact: Michael E. Kelly Phone: 414-805-4380
Email not avaialable




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