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.]

NCT02359565 : Pembrolizumab in Treating Younger Patients With Recurrent, Progressive, or Refractory High-Grade Gliomas, Diffuse Intrinsic Pontine Gliomas, or Hypermutated Brain Tumors
PhasePhase 1
AgesMin: 1 Year Max: 29 Years
Eligibility
Inclusion Criteria:

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): Tumor:

- A diffuse intrinsic pontine glioma (DIPG) that is recurrent, progressive or
refractory; histologic diagnosis is not required for patients with typical
imaging findings of DIPG (defined as patients with a diffuse expansile mass
centered in and involving at least 2/3 of the pons); patients with brainstem
tumors who have undergone biopsy with a diagnosis of high-grade glioma or diffuse
infiltrating glioma are also eligible

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): Patients with
DIPG who have tissue available are requested to submit similar tissue as patients with
NB-HGG; however, this is not required for eligibility

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): All subjects
must have measurable disease in 2-dimensions on MRI scan of the brain; disease should
be consistently measured with the two largest perpendicular dimensions

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): Patients must
have received prior radiation therapy and/or chemotherapy and recovered from the acute
treatment related toxicities (defined as =< grade 1 if not defined in eligibility
criteria) of all prior chemotherapy, immunotherapy or radiotherapy prior to entering
this study; there is no upper limit to the number of prior therapies that is allowed

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): Patients must
have received their last dose of known myelosuppressive anticancer therapy at least
three (3) weeks prior to study enrollment or at least six (6) weeks if prior
nitrosourea

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): Biologic or
investigational agent (anti-neoplastic): patient must have received their last dose of
the investigational or biologic agent >= 7 days prior to study enrollment

- For agents 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 must be discussed with and approved by
the study chair

- Monoclonal antibody treatment and/or agents with prolonged half-lives: at least
three half-lives must have elapsed prior to enrollment

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): Patient must
have completed immunotherapy (e.g. tumor vaccines, oncolytic viruses, etc.) at least
42 days prior to enrollment

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): Patients must
have had their last fraction of:

- Craniospinal irradiation >= 3 months prior to enrollment

- Other substantial bone marrow irradiation >= 6 weeks prior to enrollment

- Local palliative radiation therapy (XRT) (small port) >= 2 weeks

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): Patient must be
>= 12 weeks since autologous bone marrow/stem cell transplant prior to enrollment

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): Patients must
be fully recovered from all acute effects of prior surgical intervention

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): All races and
ethnic groups are eligible for this study

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): Patients with
neurological deficits should have deficits that are completely stable for a minimum of
1 week (7 days) prior to enrollment

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): Karnofsky
performance scale (KPS for > 16 years of age) or Lansky performance score (LPS for =<
16 years of age) assessed within two weeks of enrollment must be >= 70; patients who
are unable to walk because of neurologic deficits, but who are up in a wheelchair,
will be considered ambulatory for the purpose of assessing the performance score

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): Absolute
neutrophil count >= 1.0 x 10^9 cells/L

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): Platelets >=
100,000/mm^3 (unsupported, defined as no platelet transfusion within 7 days)

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): Hemoglobin >= 8
g/dl (may receive transfusions)

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): Total bilirubin
=< 1.5 times institutional upper limit of normal (ULN)

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): Alanine
aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x
institutional upper limit of normal

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): Albumin >= 2
g/dl

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): Serum
creatinine based on age/gender as noted below; patients that do not meet the criteria
below but have a 24 hour creatinine clearance or glomerular filtration rate (GFR)
(radioisotope or iothalamate) >= 70 ml/min/1.73 m^2 are eligible

- 1 to < 2 years: 0.6 mg/dl

- 2 to < 6 years: 0.8 mg/dl

- 6 to < 10 years: 1 mg/dl

- 10 to < 13 years: 1.2 mg/dl

- 13 to < 16 years: 1.5 mg/dl (male), 1.4 mg/dl (female)

- >= 16 years: 1.7 mg/dl (male), 1.4 mg/dl (female)

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): Pulse oximetry
> 93% on room air and no evidence of dyspnea at rest

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): Patients must
be off all colony-forming growth factor(s) for at least 1 week prior to registration
(i.e. filgrastim, sargramostim, erythropoietin); 2 weeks must have elapsed for
long-acting formulations

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): Patients must
be willing to use brief courses (at least 72 hours) of steroids as directed for
potential inflammatory side effects of the therapy if recommended by their treating
physician

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): Female subjects
of childbearing potential must not be pregnant or breast-feeding; female patients of
childbearing potential must have a negative serum or urine pregnancy test within 72
hours prior to receiving the first dose of study medication; if the urine test is
positive or cannot be confirmed as negative, a serum pregnancy test will be required;
pregnant women are excluded from this study; breastfeeding should be discontinued if
the mother is to be treated with MK-3475 (pembrolizumab)

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): Patients of
childbearing or child fathering potential must be willing to use 2 methods of birth
control or be surgically sterile or abstain from heterosexual activity while being
treated on this study and for 4 months after the last dose of study medication

- INCLUSION CRITERIA FOR DIPG (STRATUM A - CURRENTLY CLOSED TO ACCRUAL): The patient or
parent/guardian is able to understand the consent and is willing to sign a written
informed consent document, inclusive of assent where appropriate, according to
institutional guidelines

- INCLUSION CRITERIA FOR NB-NGG (STRATUM B): Tumor:

- Patients must have a histologically confirmed diagnosis of a non-brainstem
high-grade glioma that is recurrent, progressive or refractory; spinal primary
disease is eligible

- NCLUSION CRITERIA FOR NB-NGG (STRATUM B): Patients with non-brainstem high grade
glioma must have adequate pre-trial FFPE tumor material available for use in the
biology studies and genome wide sequencing; while tissue is required for PD-1, PD-L1
and immunophenotyping, patients will be deemed eligible for the study with a minimum
of 10 unstained slides for the PD-1/PD-L1 immunohistochemical analysis

- NCLUSION CRITERIA FOR NB-NGG (STRATUM B): All subjects must have measurable disease in
2-dimensions on MRI scan of the brain; disease should be consistently measured with
the two largest perpendicular dimensions

- INCLUSION CRITERIA FOR NB-NGG (STRATUM B): Patients must have received prior radiation
therapy and/or chemotherapy and recovered from the acute treatment related toxicities
(defined as =< grade 1 if not defined in eligibility criteria) of all prior
chemotherapy, immunotherapy or radiotherapy prior to entering this study; there is no
upper limit to the number of prior therapies that is allowed

- INCLUSION CRITERIA FOR NB-NGG (STRATUM B): Patients must have received their last dose
of known myelosuppressive anticancer therapy at least three (3) weeks prior to study
enrollment or at least six (6) weeks if prior nitrosourea

- INCLUSION CRITERIA FOR NB-NGG (STRATUM B): Biologic or investigational agent
(anti-neoplastic): patient must have received their last dose of the investigational
or biologic agent >= 7 days prior to study enrollment

- For agents 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 must be discussed with and approved by
the study chair

- Monoclonal antibody treatment and/or agents with prolonged half-lives: at least
three half-lives must have elapsed prior to enrollment

- INCLUSION CRITERIA FOR NB-NGG (STRATUM B): Patient must have completed immunotherapy
(e.g. tumor vaccines, oncolytic viruses, etc.) at least 42 days prior to enrollment

- INCLUSION CRITERIA FOR NB-NGG (STRATUM B): Patients must have had their last fraction
of:

- Craniospinal irradiation >= 3 months prior to enrollment

- Other substantial bone marrow irradiation >= 6 weeks prior to enrollment

- Local palliative XRT (small port) >= 2 weeks

- INCLUSION CRITERIA FOR NB-NGG (STRATUM B): Patient must be >= 12 weeks since
autologous bone marrow/stem cell transplant prior to enrollment

- INCLUSION CRITERIA FOR NB-NGG (STRATUM B): Patients must be fully recovered from all
acute effects of prior surgical intervention

- INCLUSION CRITERIA FOR NB-NGG (STRATUM B): All races and ethnic groups are eligible
for this study

- INCLUSION CRITERIA FOR NB-NGG (STRATUM B): Patients with neurological deficits should
have deficits that are completely stable for a minimum of 1 week (7 days) prior to
enrollment

- INCLUSION CRITERIA FOR NB-NGG (STRATUM B): Karnofsky performance scale (KPS for > 16
years of age) or Lansky performance score (LPS for =< 16 years of age) assessed within
two weeks of enrollment must be >= 70; patients who are unable to walk because of
neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for
the purpose of assessing the performance score

- INCLUSION CRITERIA FOR NB-NGG (STRATUM B): Absolute neutrophil count >= 1.0 x 10^9
cells/L

- INCLUSION CRITERIA FOR NB-NGG (STRATUM B): Platelets >= 100,000/mm^3 (unsupported,
defined as no platelet transfusion within 7 days)

- INCLUSION CRITERIA FOR NB-NGG (STRATUM B): Hemoglobin >= 8 g/dl (may receive
transfusions)

- INCLUSION CRITERIA FOR NB-NGG (STRATUM B): Total bilirubin =< 1.5 times institutional
upper limit of normal (ULN)

- INCLUSION CRITERIA FOR NB-NGG (STRATUM B): ALT (SGPT) =< 3 x institutional upper limit
of normal

- INCLUSION CRITERIA FOR NB-NGG (STRATUM B): Albumin >= 2 g/dl

- INCLUSION CRITERIA FOR NB-NGG (STRATUM B): Serum creatinine based on age/gender as
noted below; patients that do not meet the criteria below but have a 24 hour
creatinine clearance or GFR (radioisotope or iothalamate) >= 70 ml/min/1.73 m^2 are
eligible

- 1 to < 2 years: 0.6 mg/dl

- 2 to < 6 years: 0.8 mg/dl

- 6 to < 10 years: 1 mg/dl

- 10 to < 13 years: 1.2 mg/dl

- 13 to < 16 years: 1.5 mg/dl (male), 1.4 mg/dl (female)

- >= 16 years: 1.7 mg/dl (male), 1.4 mg/dl (female)

- INCLUSION CRITERIA FOR NB-NGG (STRATUM B): Pulse oximetry > 93% on room air and no
evidence of dyspnea at rest

- INCLUSION CRITERIA FOR NB-NGG (STRATUM B): Patients must be off all colony-forming
growth factor(s) for at least 1 week prior to registration (i.e. filgrastim;
sargramostim; erythropoietin); 2 weeks must have elapsed for long-acting formulations

- INCLUSION CRITERIA FOR NB-NGG (STRATUM B): Patients must be willing to use brief
courses (at least 72 hours) of steroids as directed for potential inflammatory side
effects of the therapy if recommended by their treating physician

- INCLUSION CRITERIA FOR NB-NGG (STRATUM B): Female subjects of childbearing potential
must not be pregnant or breast-feeding; female patients of childbearing potential must
have a negative serum or urine pregnancy test within 72 hours prior to receiving the
first dose of study medication; if the urine test is positive or cannot be confirmed
as negative, a serum pregnancy test will be required; pregnant women are excluded from
this study; breastfeeding should be discontinued if the mother is to be treated with
MK-3475 (pembrolizumab)

- INCLUSION CRITERIA FOR NB-NGG (STRATUM B): Patients of childbearing or child fathering
potential must be willing to use 2 methods of birth control or be surgically sterile
or abstain from heterosexual activity while being treated on this study and for 4
months after the last dose of study medication

- INCLUSION CRITERIA FOR NB-NGG (STRATUM B): The patient or parent/guardian is able to
understand the consent and is willing to sign a written informed consent document,
inclusive of assent where appropriate, according to institutional guidelines

- INCLUSION CRITERIA FOR HYPERMUTATED BRAIN TUMORS (STRATUM C): Patients with brain
tumors and increased tumor mutation burden as determined by

- Confirmed diagnosis of CMMRD syndrome by CLIA-certified germline gene sequencing
OR

- Confirmation of high mutation burden by whole genome/exome sequencing performed
in a CLIA-certified laboratory and/or the use of Foundation One next generation
sequence panel or another CLIA approved targeted sequencing lab with publicly
available correlations between number of mutations found in the panel and
mutations per megabase and/or genome; for protocol purposes a high mutation
burden will be defined as at least 100 non-synonymous coding-region mutations by
whole exome/genome sequencing (well above two standard deviations of the number
of median similar mutations described in pediatric central nervous system [CNS]
cancers) AND/OR a high tumor mutation burden (TMB) or intermediate TMB based on
the reporting parameters of the panel; TMB parameters provided for the Foundation
One reports are high tumor mutation burden is >= 20 mutations per megabase or
intermediate TMB is between 6 to 19 mutations per megabase

- Confirmed diagnosis of Lynch syndrome by CLIA-certified germline gene sequencing;
patients with Lynch syndrome will not be accounted for in primary objective
unless their tumors are determined to have the minimum number of mutations
described above but they will still
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02359565      |      Link to official Clinicaltrials.gov listing
Locations
Los Angeles, California
Facility: Children's Hospital Los Angeles
Investigator: Girish Dhall
Contact: Girish Dhall Phone: 888-823-5923
Click HERE to send email to this center

Palo Alto, California
Facility: Lucile Packard Children's Hospital Stanford University
Investigator: Paul G. Fisher
Contact: Paul G. Fisher Phone: 650-498-7061
Click HERE to send email to this center

Washington, District of Columbia
Facility: Children's National Medical Center
Investigator: Lindsay B. Kilburn
Contact: Lindsay B. Kilburn Phone: 713-798-1354
Click HERE to send email to this center

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

New York, New York
Facility: Memorial Sloan-Kettering Cancer Center
Investigator: Ira J. Dunkel
Contact: Ira J. Dunkel Phone: 541-143-0843
Email not avaialable

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

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

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

Houston, Texas
Facility: Texas Children's Hospital
Investigator: Patricia A. Baxter
Contact: Patricia A. Baxter Phone: 713-798-1354
Click HERE to send email to this center




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