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.]

NCT03220035 : Pediatric MATCH: Vemurafenib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With BRAF V600 Mutations
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 APEC1621G based on the
presence of a BRAF V600 mutation

- Patients must have a body surface area >= 0.37 m^2 at enrollment while the 120 mg
strength tablet supply is available; patients < 0.73 m^2 must follow the dosing
nomogram; patients >= 0.73 m^2 at enrollment must follow the dosing nomogram

- Patients enrolled after the drug supply of the 120 mg strength has been exhausted must
have a body surface area >= 0.73 m^2 at enrollment and follow the dosing nomogram

- Patients must have radiographically measurable disease at the time of study
enrollment; patients with neuroblastoma who do not have measurable disease but have
metaiodobenzylguanidine (MIBG) positive (+) 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, iobenguane I-131
[131I-MIBG]): >= 42 days after systemically administered radiopharmaceutical
therapy

- Patients must not have received prior exposure to a BRAF inhibitor (e.g.
vemurafenib, dabrafenib or encorafenib)

- 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 in above criteria (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; 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

- 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; Note: 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 must be able to swallow intact tablets

- 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 and for 6 months after the
last dose of vemurafenib

- 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 moderate to strong inducers or
inhibitors of CYP3A4 are not eligible; moderate to strong inducers or inhibitors of
CYP3A4 should be avoided from 14 days prior to enrollment to the end of the study;
Note: CYP3A4 inducing anti-epileptic drugs and dexamethasone for CNS tumors or
metastases, on a stable dose, are allowed

- Patients who are currently receiving drugs that are inhibitors or inducers of
p-glycoprotein (P-gp) or adenosine triphosphate (ATP)-binding cassette, subfamily G,
member 2 (ABCG2 [BCRP]) are not eligible

- Patients with known active cutaneous squamous cell carcinoma (includes keratoacanthoma
or mixed keratoacanthoma subtype) are not eligible; patients who have fully excised
lesions with dermatologic confirmation of absence of disease are eligible

- Patients with low grade glioma patients (World Health Organization [WHO] grades I and
II) are not eligible

- Patients who have an uncontrolled infection are not eligible

- Patients who have received a 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=NCT03220035      |      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

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

Rochester, New York
Facility: University of Rochester
Investigator: Jeffrey R. Andolina
Contact: Jeffrey R. Andolina Phone: 585-275-5830
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
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: AeRang Kim
Contact: AeRang Kim Phone: 202-476-4744
Click HERE to send email to this center

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

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




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