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.]

NCT02095132 : WEE1 Inhibitor MK-1775 and Irinotecan Hydrochloride in Treating Younger Patients With Relapsed or Refractory Solid Tumors
PhasePhase 1/Phase 2
AgesMin: 1 Year Max: 21 Years
Eligibility
Inclusion Criteria:

- 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-human chorionic gonadotropin (HCG)

- Part A: Patients with relapsed or refractory solid tumors, including patients with
primary or metastatic CNS tumors

- Part B: Patients with relapsed or refractory neuroblastoma

- Part C: Patients with relapsed or refractory medulloblastoma or CNS PNET

- Patients must have a body surface area >= 0.35 m^2 at the time of study enrollment if
enrolling on dose levels 1-5; patients must have a body surface area >= 0.46 m^2 at
the time of study enrollment if enrolling on dose level 0

- Patients must have either measurable or evaluable disease

- Patient's current disease state must be one for which there is no known curative
therapy or therapy proven to prolong survival with an acceptable quality of life

- 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
relatively 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 chemotherapy

- At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if
prior nitrosourea)

- At least 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

- At least 7 days after the last dose of a biologic agent; 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

- At least 42 days after the completion of any type of immunotherapy, e.g. tumor
vaccines

- At least 3 half-lives of the antibody after the last dose of a monoclonal antibody

- At least 14 days after local palliative radiation therapy (XRT) (small port); at least
150 days must have elapsed if prior traumatic brain injury (TBI), craniospinal XRT or
if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial
bone marrow radiation, including therapeutic doses of Iobenguane (MIBG)

- Stem cell Infusion without TBI: no evidence of active graft vs host disease and at
least 84 days must have elapsed after transplant or stem cell infusion

- Patients previously treated with irinotecan are eligible for this study

- For patients with solid tumors without known bone marrow involvement: peripheral
absolute neutrophil count (ANC) >= 1000/mm^3

- For patients with solid tumors without known bone marrow involvement: platelet count
>= 100,000/mm^3 (transfusion independent, defined as not receiving platelet
transfusions for at least 7 days prior to enrollment)

- For patients with solid tumors without known bone marrow involvement: hemoglobin >=
8.0 g/dL (may receive red blood cell [RBC] transfusions)

- 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; at least 2 of every cohort of 3 patients must be evaluable
for hematologic toxicity for Part A, the dose escalation part of the study; if
dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must
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: 0.6 mg/dL

- Age 2 to < 6 years: 0.8 mg/dL

- Age 6 to < 10 years: 1 mg/dL

- Age 10 to < 13 years: 1.2 mg/dL

- Age 13 to < 16 years: 1.5 mg/dL (males), 1.4 mg/dL (females)

- Age >= 16 years: 1.7 mg/dL (males), 1.4 mg/dL (females)

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

- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 110
U/L; for the purpose of this study, the ULN for SGPT is 45 U/L

- Serum albumin >= 2 g/dL

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

- Nervous system disorders (Common Terminology Criteria for Adverse Events version 4
[CTCAE v4]) resulting from prior therapy must be =< grade 2

- 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

- Tissue blocks or slides must be sent if available, with exclusions; if tissue blocks
or slides are unavailable, the study chair must be notified prior to study enrollment

- Patients must be able to swallow capsules

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

- Males or females of reproductive potential may not participate unless they have agreed
to use an effective double barrier contraceptive method for the entire duration of
protocol therapy and for 3 months (males) and 1 month (females) after study drug
discontinuation

- 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

- 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 currently receiving drugs that are strong or moderate inhibitors
and/or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or
sensitive CYP3A4 substrates and CYP3A4 substrates with a narrow therapeutic range are
not eligible; the use of aprepitant as an antiemetic is prohibited; caution should be
exercised with concomitant administration of MK-1775 and agents that are sensitive
substrates of cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8), 2C9 and
2C19, or substrates of this enzyme with narrow therapeutic ranges, as well as agents
that are inhibitors or substrates of permeability glycoprotein (P-gp)

- 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 must not have received enzyme inducing anticonvulsants for at least 14 days
prior to enrollment

- 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

- 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

- Patients with a history of allergic reaction to irinotecan, cephalosporins or a severe
penicillin allergy are not eligible

- Patients unable to swallow capsules whole are not eligible; nasogastric or gastric (G)
tube administration is not allowed
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02095132      |      Link to official Clinicaltrials.gov listing
Locations
Los Angeles, California
Facility: Children's Hospital Los Angeles
Investigator: Leo Mascarenhas
Contact: Leo Mascarenhas Phone: 888-823-5923
Click HERE to send email to this center

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

San Francisco, California
Facility: UCSF Medical Center-Mission Bay
Investigator: Kieuhoa T. Vo
Contact: Kieuhoa T. Vo Phone: 877-827-3222
Email not avaialable

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: Jeffrey S. Dome
Contact: Jeffrey S. Dome Phone: 888-823-5923
Click HERE to send email to this center

Atlanta, Georgia
Facility: Children's Healthcare of Atlanta - Egleston
Investigator: William T. Cash
Contact: William T. Cash 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: Rajen Mody
Contact: Rajen Mody 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

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: Michael W. Bishop
Contact: Michael W. Bishop 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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