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.]

NCT03155620 : Pediatric MATCH: Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders
PhasePhase 2
AgesMin: 12 Months Max: 21 Years
Eligibility
Inclusion Criteria:

- ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients with recurrent or
refractory solid tumors (including non-Hodgkin lymphomas, histiocytoses [e.g.
Langerhans cell histiocytosis (LCH), juvenile xanthogranuloma (JXG), histiocytic
sarcoma], and central nervous system [CNS] tumors) are eligible; patients must have
had histologic verification of malignancy at original diagnosis or relapse except in
patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with
pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers
including alpha-fetoprotein or beta-HCG

- ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients must have a formalin
fixed paraffin embedded (FFPE) tumor sample available for MATCH study testing from a
biopsy or surgery that was performed at any point after initial tumor
recurrence/progression, or be planned to have a procedure to obtain such a sample that
is considered to be of potential benefit by the treating clinicians; a tumor sample
from a clinically performed diagnostic (pre-treatment) biopsy will be acceptable for
enrollment onto pediatric MATCH for children with diffuse intrinsic pontine gliomas
(DIPG, brainstem gliomas)

- ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: 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

- GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: NOTE: patient does not need to meet all
subprotocol criteria at time of enrollment onto the APEC1621 screening protocol, but
will need to meet all criteria prior to enrollment on any assigned treatment
subprotocol; patients must be enrolled onto a subprotocol within 8 weeks (56 days) of
treatment assignment

- GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: 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

- GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: At the time of treatment with subprotocol
specified therapy, the patients must have radiographically measurable disease;
patients with neuroblastoma who do not have measurable disease but have iobenguane
(MIBG) positive (+) evaluable 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 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

- GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: At the time of enrollment onto a
subprotocol, the following general criteria for initiation of therapy will be
required:

- Patients must have fully recovered from the acute toxic effects of all prior
anticancer therapy and must meet the following minimum duration from prior
anticancer directed therapy prior to enrollment to the subprotocol; 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 anticancer agents known to be
myelosuppressive: for agents not listed, the duration of this interval must
be discussed with the study chair and the study-assigned research
coordinator prior to enrollment

- >= 21 days after the last dose of cytotoxic or myelosuppressive
chemotherapy (42 days if prior nitrosourea)

- Anticancer agents not known to be myelosuppressive (e.g. not associated with
reduced platelet or absolute neutrophil counts [ANC]): >= 7 days after the
last dose of agent; for agents not listed, the duration of this interval
must be discussed with the study chair and the study-assigned research
coordinator prior to enrollment

- 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. Neulasta) or 7 days for short-acting growth
factor; 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 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 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 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, NK cells, dendritic cells, etc.)

- X-ray 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

- GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: 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

- GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: 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

- GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Creatinine clearance or radioisotope
glomerular filtration rate (GFR) >= 70ml/min/1.73 m^2 or a serum creatinine based on
age/gender as follows:

- Age: 1 to < 2 years; maximum serum creatinine (mg/dL): male 0.6; female 0.6

- Age: 2 to < 6 years; maximum serum creatinine (mg/dL): male 0.8; female 0.8

- Age: 6 to < 10 years; maximum serum creatinine (mg/dL): male 1; female 1

- Age: 10 to < 13 years; maximum serum creatinine (mg/dL): male 1.2; female 1.2

- Age: 13 to < 16 years; maximum serum creatinine (mg/dL): male 1.5; female 1.4

- Age: >= 16 years; maximum serum creatinine (mg/dL): male 1.7; female 1.4

- GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Bilirubin (sum of conjugated +
unconjugated) =< 1.5 x upper limit of normal (ULN) for age

- GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: serum glutamate pyruvate transaminase
(SGPT) (alanine transferase [ALT]) =< 135 U/L (for the purpose of this study, the ULN
for SGPT is 45 U/L)

- GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Patients must be able to swallow intact
capsules/tablets, unless otherwise specified in the subprotocol to which they are
assigned

- GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Agent specific limitations on prior
therapy will be included with specific treatment subprotocols

Exclusion Criteria:

- GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Pregnant or breast-feeding women will not
be entered on this study; pregnancy tests must be obtained in females who are
post-menarchal; males or females of reproductive potential may not participate unless
they have agreed to use an effective contraceptive method

- GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Concomitant medications

- Corticosteroids: at the time of consent and enrollment to regimen specific
subprotocols, patients receiving corticosteroids who have not been on a stable or
decreasing dose of corticosteroid for at least 7 days prior to enrollment to the
subprotocol will not be eligible; if used to modify immune adverse events related
to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid

- Investigational drugs: patients must meet criteria for prior therapy at the time
of consent and enrollment to a subprotocol; other investigational agents may not
be administered to patients while they are receiving study drug as part of a
subprotocol

- Anticancer agents: patients must meet criteria for prior therapy at the time of
consent and enrollment to a subprotocol; other investigational agents may not be
administered to patients while they are receiving study drug as part of a
subprotocol

- Anti-GVHD agents post-transplant: patients who are receiving cyclosporine,
tacrolimus or other agents to prevent graft-versus-host disease post bone marrow
transplant are not eligible

- GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Patients who have an uncontrolled
infection are not eligible

- GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Patients who have had a prior solid organ
transplant are not eligible

- GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Additional agent specific criteria will
be included with specific treatment subprotocols
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT03155620      |      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

Little Rock, Arkansas
Facility: Arkansas Children's Hospital
Investigator: David L. Becton
Contact: David L. Becton Phone: 501-686-8274
Email not avaialable

Oakland, California
Facility: Children's Hospital and Research Center at Oakland
Investigator: Carla B. Golden
Contact: Carla B. Golden
Click HERE to send email to this center

Des Moines, Iowa
Facility: Blank Children's Hospital
Investigator: Wendy L. Woods-Swafford
Contact: Wendy L. Woods-Swafford Phone: 515-241-3305
Click HERE to send email to this center

New Orleans, Louisiana
Facility: Ochsner Medical Center Jefferson
Investigator: Craig Lotterman
Contact: Craig Lotterman Phone: 504-842-3708
Email not avaialable

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

Las Vegas, Nevada
Facility: University Medical Center of Southern Nevada
Investigator: Alan K. Ikeda
Contact: Alan K. Ikeda Phone: 702-384-0013
Email not avaialable

Las Vegas, Nevada
Facility: Children's Specialty Center of Nevada II
Investigator: Alan K. Ikeda
Contact: Alan K. Ikeda Phone: 702-384-0013
Email not avaialable

Las Vegas, Nevada
Facility: Summerlin Hospital Medical Center
Investigator: Alan K. Ikeda
Contact: Alan K. Ikeda Phone: 702-384-0013
Email not avaialable

Morristown, New Jersey
Facility: Morristown Medical Center
Investigator: Steven L. Halpern
Contact: Steven L. Halpern Phone: 201-996-2879
Email not avaialable

Akron, Ohio
Facility: Children's Hospital Medical Center of Akron
Investigator: Steven J. Kuerbitz
Contact: Steven J. Kuerbitz
Click HERE to send email to this center

Oklahoma City, Oklahoma
Facility: University of Oklahoma Health Sciences Center
Investigator: Rene Y. McNall-Knapp
Contact: Rene Y. McNall-Knapp Phone: 405-271-8777
Click HERE to send email to this center

Portland, Oregon
Facility: Legacy Emanuel Children's Hospital
Investigator: Janice F. Olson
Contact: Janice F. Olson Phone: 503-413-8199
Email not avaialable

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

Philadelphia, Pennsylvania
Facility: Childrens Oncology Group
Investigator: Donald W. Parsons
Contact: Donald W. Parsons Phone: 713-798-1354
Email not avaialable

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

Greenville, South Carolina
Facility: BI-LO Charities Children's Cancer Center
Investigator: Nichole L. Bryant
Contact: Nichole L. Bryant
Click HERE to send email to this center

Memphis, Tennessee
Facility: St. Jude Children's Research Hospital
Investigator: Alberto S. Pappo
Contact: Alberto S. Pappo
Click HERE to send email to this center

Dallas, Texas
Facility: Medical City Dallas Hospital
Investigator: Stanton C. Goldman
Contact: Stanton C. Goldman Phone: 972-566-5588
Email not avaialable

Dallas, Texas
Facility: UT Southwestern/Simmons Cancer Center-Dallas
Investigator: Theodore W. Laetsch
Contact: Theodore W. Laetsch Phone: 214-648-7097
Email not avaialable

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

Norfolk, Virginia
Facility: Childrens Hospital-King's Daughters
Investigator: Eric J. Lowe
Contact: Eric J. Lowe
Click HERE to send email to this center

Spokane, Washington
Facility: Providence Sacred Heart Medical Center and Children's Hospital
Investigator: Judy L. Felgenhauer
Contact: Judy L. Felgenhauer
Click HERE to send email to this center

Morgantown, West Virginia
Facility: West Virginia University Healthcare
Investigator: Stephan R. Paul
Contact: Stephan R. Paul Phone: 304-293-7374
Click HERE to send email to this center




Home | Brain Tumor Guide | FAQs | Find A Treatment
Noteworthy Treatments | News | Virtual Trial | Videos | Novocure Optune® | Newsletter
Donations | Brain Tumor Centers | Survivor Stories | Temodar®
Fundraising For Research | Unsubscribe | Contact Us

Copyright (c) 1993 - 2017 by:
The Musella Foundation For Brain Tumor Research & Information, Inc
1100 Peninsula Blvd
Hewlett, NY 11557
888-295-4740


Website Design By
World Wide Websites