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.]

NCT03213665 : Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A Pediatric MATCH Treatment Trial)
PhasePhase 2
AgesMin: 12 Months Max: 21 Years
Eligibility
Inclusion Criteria:

- Patient must have enrolled onto APEC1621SC and must have been given a treatment
assignment to Molecular Analysis for Therapy Choice (MATCH) to APEC1621C 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
MIBG+ 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
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, 131I-MIBG): >= 42 days
after systemically administered radiopharmaceutical therapy

- Patients must not have had prior exposure to tazemetostat or other inhibitor(s)
of EZH2

- For patients with solid tumors without known bone marrow involvement:

- 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)

- 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 or a serum creatinine based on age/gender as follows:

- Age 1 to < 2 years: male: 0.6 mg/dL; female: 0.6 mg/dL

- Age 2 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

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

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

- Serum albumin >= 2 g/dL

- Corrected QT (QTc) interval =< 480 milliseconds

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

- Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE]
version [V] 4.0) resulting from prior therapy must be =< grade 2

- International normalized ratio (INR) =< 1.5

- For subjects with CNS involvement (primary tumor or metastatic disease): Subjects must
not have any active bleeding, or new intratumoral hemorrhage of more than punctate
size on screening MRI or known bleeding diathesis or treatment with anti-platelet or
anti-thrombotic agents

- 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; 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 an effective
contraceptive method for the duration of study treatment

- 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 strong inducers or strong
inhibitors of CYP3A4 are not eligible; Note: Dexamethasone for CNS tumors or
metastases, on a stable dose, is allowed

- Patients who have an uncontrolled infection are not eligible

- Patients who have received 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
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT03213665      |      Link to official Clinicaltrials.gov listing
Locations
Mesa, Arizona
Facility: Cardon Children's Medical Center
Investigator: Erlyn C. Smith
Contact: Erlyn C. Smith
Click HERE to send email to this center

Phoenix, Arizona
Facility: Phoenix Childrens Hospital
Investigator: Jessica Boklan
Contact: Jessica Boklan Phone: 602-546-0920
Email not avaialable

Little Rock, Arkansas
Facility: Arkansas Children's Hospital
Investigator: David L. Becton
Contact: David L. Becton
Click HERE to send email to this center

Downey, California
Facility: Southern California Permanente Medical Group
Investigator: Robert M. Cooper
Contact: Robert M. Cooper Phone: 626-564-3455
Email not avaialable

Long Beach, California
Facility: Miller Children's and Women's Hospital Long Beach
Investigator: Pamela H. Kempert
Contact: Pamela H. Kempert
Click HERE to send email to this center

Madera, California
Facility: Children's Hospital Central California
Investigator: Vonda L. Crouse
Contact: Vonda L. Crouse
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Oakland, California
Facility: Children's Hospital and Research Center at Oakland
Investigator: Carla B. Golden
Contact: Carla B. Golden
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Oakland, California
Facility: Kaiser Permanente-Oakland
Investigator: Steven K. Bergstrom
Contact: Steven K. Bergstrom Phone: 877-642-4691
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Gainesville, Florida
Facility: University of Florida Health Science Center - Gainesville
Investigator: William B. Slayton
Contact: William B. Slayton
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Hollywood, Florida
Facility: Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Investigator: Iftikhar Hanif
Contact: Iftikhar Hanif
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Miami, Florida
Facility: Nicklaus Children's Hospital
Investigator: Enrique A. Escalon
Contact: Enrique A. Escalon
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Orlando, Florida
Facility: Arnold Palmer Hospital for Children
Investigator: Vincent F. Giusti
Contact: Vincent F. Giusti Phone: 321-843-2584
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Tampa, Florida
Facility: Saint Joseph's Hospital/Children's Hospital-Tampa
Investigator: Mark J. Mogul
Contact: Mark J. Mogul
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Boise, Idaho
Facility: Saint Luke's Mountain States Tumor Institute
Investigator: Eugenia Chang
Contact: Eugenia Chang
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Indianapolis, Indiana
Facility: Riley Hospital for Children
Investigator: Kamnesh R. Pradhan
Contact: Kamnesh R. Pradhan Phone: 800-248-1199
Email not avaialable

New Orleans, Louisiana
Facility: Ochsner Medical Center Jefferson
Investigator: Craig Lotterman
Contact: Craig Lotterman Phone: 504-703-8712
Click HERE to send email to this center

Baltimore, Maryland
Facility: Johns Hopkins University/Sidney Kimmel Cancer Center
Investigator: Kenneth J. Cohen
Contact: Kenneth J. Cohen Phone: 410-955-8804
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Ann Arbor, Michigan
Facility: C S Mott Children's Hospital
Investigator: Rajen Mody
Contact: Rajen Mody
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Minneapolis, Minnesota
Facility: University of Minnesota/Masonic Cancer Center
Investigator: Emily G. Greengard
Contact: Emily G. Greengard
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Jackson, Mississippi
Facility: University of Mississippi Medical Center
Investigator: Anderson (Andy) B. Collier
Contact: Anderson (Andy) B. Collier Phone: 601-815-6700
Email not avaialable

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

Saint Louis, Missouri
Facility: Mercy Hospital Saint Louis
Investigator: Bethany G. Sleckman
Contact: Bethany G. Sleckman Phone: 314-251-6770
Email not avaialable

Morristown, New Jersey
Facility: Morristown Medical Center
Investigator: Steven L. Halpern
Contact: Steven L. Halpern Phone: 973-971-5900
Email not avaialable

Buffalo, New York
Facility: Roswell Park Cancer Institute
Investigator: Clare J. Twist
Contact: Clare J. Twist Phone: 877-275-7724
Email not avaialable

New Hyde Park, New York
Facility: The Steven and Alexandra Cohen Children's Medical Center of New York
Investigator: Julie I. Krystal
Contact: Julie I. Krystal
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New York, New York
Facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone
Investigator: Sharon L. Gardner
Contact: Sharon L. Gardner Phone: 212-263-4434
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Syracuse, New York
Facility: State University of New York Upstate Medical University
Investigator: Philip M. Monteleone
Contact: Philip M. Monteleone Phone: 315-464-5476
Email not avaialable

Durham, North Carolina
Facility: Duke University Medical Center
Investigator: Susan G. Kreissman
Contact: Susan G. Kreissman Phone: 888-275-3853
Email not avaialable

Cincinnati, Ohio
Facility: Cincinnati Children's Hospital Medical Center
Investigator: James I. Geller
Contact: James I. Geller
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Dayton, Ohio
Facility: Dayton Children's Hospital
Investigator: Ayman A. El-Sheikh
Contact: Ayman A. El-Sheikh
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Toledo, Ohio
Facility: The Toledo Hospital/Toledo Children's Hospital
Investigator: Jamie L. Dargart
Contact: Jamie L. Dargart Phone: 419-824-1842
Email not avaialable

Oklahoma City, Oklahoma
Facility: University of Oklahoma Health Sciences Center
Investigator: Rene Y. McNall-Knapp
Contact: Rene Y. McNall-Knapp Phone: 405-271-8777
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Portland, Oregon
Facility: Oregon Health and Science University
Investigator: Suman Malempati
Contact: Suman Malempati Phone: 503-494-1080
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Philadelphia, Pennsylvania
Facility: Children's Hospital of Philadelphia
Investigator: Elizabeth Fox
Contact: Elizabeth Fox
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Philadelphia, Pennsylvania
Facility: Childrens Oncology Group
Investigator: Susan N. Chi
Contact: Susan N. Chi Phone: 617-632-4386
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Pittsburgh, Pennsylvania
Facility: Children's Hospital of Pittsburgh of UPMC
Investigator: Jean M. Tersak
Contact: Jean M. Tersak
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Knoxville, Tennessee
Facility: East Tennessee Childrens Hospital
Investigator: Ray C. Pais
Contact: Ray C. Pais Phone: 865-541-8266
Email not avaialable

Memphis, Tennessee
Facility: St. Jude Children's Research Hospital
Investigator: Alberto S. Pappo
Contact: Alberto S. Pappo
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Dallas, Texas
Facility: UT Southwestern/Simmons Cancer Center-Dallas
Investigator: Theodore W. Laetsch
Contact: Theodore W. Laetsch Phone: 214-648-7097
Email not avaialable

Fort Worth, Texas
Facility: Cook Children's Medical Center
Investigator: Kelly L. Vallance
Contact: Kelly L. Vallance
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Norfolk, Virginia
Facility: Childrens Hospital-King's Daughters
Investigator: Eric J. Lowe
Contact: Eric J. Lowe
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Seattle, Washington
Facility: Seattle Children's Hospital
Investigator: Douglas S. Hawkins
Contact: Douglas S. Hawkins
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Madison, Wisconsin
Facility: University of Wisconsin Hospital and Clinics
Investigator: Kenneth B. De Santes
Contact: Kenneth B. De Santes Phone: 800-622-8922
Email not avaialable

Milwaukee, Wisconsin
Facility: Children's Hospital of Wisconsin
Investigator: Paul D. Harker-Murray
Contact: Paul D. Harker-Murray Phone: 414-955-4727
Click HERE to send email to this center




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