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Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gliomas

Primary Purpose

Malignant Glioma, Recurrent Brain Neoplasm, Recurrent Childhood Central Nervous System Neoplasm

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pharmacological Study
Selinexor
Sponsored by
Children's Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Glioma

Eligibility Criteria

12 Months - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must have a body surface area (BSA) >= 0.84 m^2
  • Diagnosis:

    • Part A: Patients with recurrent or refractory solid tumors, including lymphoma and 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-human chorionic gonadotropin (HCG)
    • Part B: Patients with recurrent or refractory high grade glioma (World Health Organization [WHO] grade III/IV) including disseminated tumors (excluding diffuse intrinsic pontine glioma [DIPG]), not requiring surgical resection; patients must have had histologic verification of malignancy at original diagnosis or relapse
    • Part C: Patients with recurrent or refractory high grade glioma (WHO grade III/IV) and requiring surgical resection (excluding DIPG and disseminated tumors), who in the opinion of treating physicians, are medically stable to receive 2 doses of selinexor (8-10 days of treatment) before undergoing surgery without compromising the success of the procedure; note that if, in the opinion of treating physicians, current symptoms necessitate surgery before 2 doses will be able to be received, surgery should not be delayed to administer selinexor, and the patient would be ineligible for protocol therapy
  • Disease status:

    • Part A: Patients must have either measurable or evaluable disease
    • Parts B and C: Patients must have measurable disease on imaging
  • 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 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

    • Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)
    • Hematopoietic growth factors: 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
    • Biologic (anti-neoplastic agent): 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
    • Immunotherapy: At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines
    • 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
    • External beam radiation therapy (XRT): At least 14 days after local palliative XRT (small port); at least 150 days must have elapsed if prior total body irradiation (TBI), craniospinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation
    • Stem cell infusion without TBI: No evidence of active graft vs. host disease and at least 56 days must have elapsed after transplant or stem cell infusion
    • Patients must not have received prior exposure to selinexor
  • 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)
  • * Hemoglobin >= 8.0 g/dL at baseline (may receive red blood cell [RBC] transfusions)
  • Patients with known bone marrow metastatic disease will be eligible for study if 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 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study; if dose-limiting hematologic toxicity is observed, all subsequent patients enrolled on Part A 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:

    • =< 0.6 mg/dL (patients age 1 to < 2 years)
    • =< 0.8 mg/dL (patients age 2 to < 6 years)
    • =< 1 mg/dL (patients age 6 to < 10 years)
    • =< 1.2 mg/dL (patients age 10 to < 13 years)
    • =< 1.4 mg/dL (female patients age >= 13 years)
    • =< 1.5 mg/dL (male patients age 13 to < 16 years)
    • =< 1.7 mg/dL (male patients age >= 16 years)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x ULN = 135 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L
  • Serum albumin >= 2 g/dL
  • Serum amylase =< 1.5 x ULN
  • Serum lipase =< 1.5 x ULN
  • Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
  • Patients must be able to swallow tablets whole
  • Part C: Archived paraffin-embedded tissue (20 unstained slides or a tumor block) from a prior resection must be available as a control for correlative studies; if tissue blocks or slides are unavailable, the study chair must be notified prior to enrollment
  • 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, since there is yet no available information regarding human fetal or teratogenic toxicities; based on its mechanism of action and findings in animals, selinexor may cause fetal harm when administered to a pregnant woman; pregnancy tests must be obtained in girls who are post-menarchal; males with female partners of reproductive potential or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control- including a medically accepted barrier method of contraceptive method (e.g., male or female condom) for the entire period in which they are receiving protocol therapy and for at least 1 week following their last dose of study drug; abstinence is an acceptable method of birth control
  • Concomitant medications

    • Corticosteroids: 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
    • Investigational drugs: Patients who are currently receiving another investigational drug are not eligible
    • Anti-cancer agents: Patients who are currently receiving other anti-cancer agents 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
  • Patients with body mass index (BMI) < 3rd percentile for age, as defined by WHO criteria for patients 1-2 years of age and Centers for Disease Control and Prevention (CDC) criteria for patients > 2 years of age, are not eligible
  • Patients with grade 3 ataxia or grade >1 extrapyramidal movement disorder are not eligible
  • Patients with known macular degeneration, uncontrolled glaucoma, or cataracts are not eligible

Sites / Locations

  • Children's Hospital of Alabama
  • Children's Hospital Los Angeles
  • Children's Hospital of Orange County
  • UCSF Medical Center-Mission Bay
  • Children's Hospital Colorado
  • Children's National Medical Center
  • Children's Healthcare of Atlanta - Egleston
  • Lurie Children's Hospital-Chicago
  • Riley Hospital for Children
  • Dana-Farber Cancer Institute
  • C S Mott Children's Hospital
  • University of Minnesota/Masonic Cancer Center
  • Washington University School of Medicine
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • Cincinnati Children's Hospital Medical Center
  • Oregon Health and Science University
  • Children's Hospital of Philadelphia
  • Children's Hospital of Pittsburgh of UPMC
  • Saint Jude Children's Research Hospital
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
  • Seattle Children's Hospital
  • Children's Hospital of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (selinexor)

Arm Description

Patients receive selinexor PO once weekly (days 1, 8, 15, and 22). Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Frequency of dose limiting toxicities of selinexor
The frequency (%) of patients experiencing a dose limiting toxicity at least possibly attributable to selinexor by study part, schema, and dose level.
Frequency of adverse events of selinexor
The frequency (%) of patients experiencing adverse events at least possibly attributable to selinexor by study part, schema, and dose level.
Area under the drug concentration curve of selinexor
The median (minimum [min], maximum [max]) of the area under the drug concentration curve for selinexor by study part, schema, and dose level.
Half-life of selinexor
The median (min,max) of the half-life of selinexor by study part, schema, and dose level.
Maximum serum concentration of selinexor
Median (min,max) of the maximum serum concentration of selinexor by study part, schema, and dose level.
Minimum serum concentration of selinexor
Median (min,max) of the minimum serum concentration of selinexor by study part, schema, and dose level.
Clearance of selinexor
Median (min,max) of the clearance of selinexor by study part, schema, and dose level.

Secondary Outcome Measures

Antitumor effect of selinexor
Frequency (%) of patients with at least partial response to selinexor by study part, schema, and dose level.
Pharmacodynamics of selinexor
Median (min,max) concentration by protein, study part, schema, and dose level.
Pharmacodynamics of selinexor in high-grade glioma (HGG) patients
Median (min,max) concentration in HGG patients by protein, study part, schema, and dose level.
Radiographic response of selinexor in HGG patients
Frequency (%) of HGG patients with radiographic response by study part, schema, and dose level.
Progression-free survival of selinexor in HGG patients
Frequency (%) of HGG patients with 6-month progression-free survival by study part, schema, and dose level.

Full Information

First Posted
December 16, 2014
Last Updated
September 28, 2023
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02323880
Brief Title
Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gliomas
Official Title
A Phase 1 Study of Selinexor (KPT-330), A Selective XPO1 Inhibitor, in Recurrent and Refractory Pediatric Solid Tumors, Including CNS Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 30, 2015 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase I trial studies the side effects and best dose of selinexor in treating younger patients with solid tumors or central nervous system (CNS) tumors that have come back (recurrent) or do not respond to treatment (refractory). Drugs used in chemotherapy, such as selinexor, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Detailed Description
PRIMARY OBJECTIVES: I. To determine the recommended phase 2 dose (RP2D) or the maximum tolerated dose (MTD) of the tablet formulation of selinexor in children with recurrent/refractory solid and CNS tumors. II. To describe the toxicities of selinexor in children with recurrent/refractory solid and CNS tumors. III. To characterize the pharmacokinetics of the tablet formulation of selinexor in children with recurrent/refractory solid and CNS tumors. SECONDARY OBJECTIVES: I. To determine the antitumor effect of selinexor in a preliminary manner in children with recurrent/refractory solid and CNS tumors. II. To determine the pharmacodynamic properties of selinexor in children and adolescents with refractory solid tumors in plasma proteins and whole blood ribonucleic acid (RNA). III. To explore the penetration, pharmacodynamic effects, and biologic effects of selinexor in tumor tissue of patients with recurrent/refractory high-grade gliomas (HGG) requiring resection. IV. To further assess the toxicity and antitumor effects of selinexor in children with recurrent/refractory HGG in expanded cohorts following dose-escalation by measuring rate of objective radiographic response (medical patients) and rate of progression-free survival (PFS) six months from the start of treatment (surgical patients). OUTLINE: This is a dose escalation study. Patients receive selinexor orally (PO) once weekly (days 1, 8, 15, and 22). Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Glioma, Recurrent Brain Neoplasm, Recurrent Childhood Central Nervous System Neoplasm, Recurrent Childhood Glioblastoma, Recurrent Lymphoma, Recurrent Malignant Solid Neoplasm, Refractory Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Primary Central Nervous System Neoplasm, WHO Grade 3 Glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (selinexor)
Arm Type
Experimental
Arm Description
Patients receive selinexor PO once weekly (days 1, 8, 15, and 22). Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Intervention Type
Other
Intervention Name(s)
Pharmacological Study
Intervention Description
Correlative studies
Intervention Type
Drug
Intervention Name(s)
Selinexor
Other Intervention Name(s)
ATG-010, CRM1 Nuclear Export Inhibitor KPT-330, KPT-330, Nexpovio, Selective Inhibitor of Nuclear Export KPT-330, SINE KPT-330, Xpovio
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Frequency of dose limiting toxicities of selinexor
Description
The frequency (%) of patients experiencing a dose limiting toxicity at least possibly attributable to selinexor by study part, schema, and dose level.
Time Frame
Up to 28 days
Title
Frequency of adverse events of selinexor
Description
The frequency (%) of patients experiencing adverse events at least possibly attributable to selinexor by study part, schema, and dose level.
Time Frame
Up to 2 years
Title
Area under the drug concentration curve of selinexor
Description
The median (minimum [min], maximum [max]) of the area under the drug concentration curve for selinexor by study part, schema, and dose level.
Time Frame
Up to 2 days
Title
Half-life of selinexor
Description
The median (min,max) of the half-life of selinexor by study part, schema, and dose level.
Time Frame
Up to 2 days
Title
Maximum serum concentration of selinexor
Description
Median (min,max) of the maximum serum concentration of selinexor by study part, schema, and dose level.
Time Frame
Up to 2 days
Title
Minimum serum concentration of selinexor
Description
Median (min,max) of the minimum serum concentration of selinexor by study part, schema, and dose level.
Time Frame
Up to 2 days
Title
Clearance of selinexor
Description
Median (min,max) of the clearance of selinexor by study part, schema, and dose level.
Time Frame
Up to 2 days
Secondary Outcome Measure Information:
Title
Antitumor effect of selinexor
Description
Frequency (%) of patients with at least partial response to selinexor by study part, schema, and dose level.
Time Frame
Up to 2 years
Title
Pharmacodynamics of selinexor
Description
Median (min,max) concentration by protein, study part, schema, and dose level.
Time Frame
Up to 28 days
Title
Pharmacodynamics of selinexor in high-grade glioma (HGG) patients
Description
Median (min,max) concentration in HGG patients by protein, study part, schema, and dose level.
Time Frame
Up to 28 days
Title
Radiographic response of selinexor in HGG patients
Description
Frequency (%) of HGG patients with radiographic response by study part, schema, and dose level.
Time Frame
Up to 2 years
Title
Progression-free survival of selinexor in HGG patients
Description
Frequency (%) of HGG patients with 6-month progression-free survival by study part, schema, and dose level.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have a body surface area (BSA) >= 0.84 m^2 Diagnosis: Part A: Patients with recurrent or refractory solid tumors, including lymphoma and 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-human chorionic gonadotropin (HCG) Part B: Patients with recurrent or refractory high grade glioma (World Health Organization [WHO] grade III/IV) including disseminated tumors (excluding diffuse intrinsic pontine glioma [DIPG]), not requiring surgical resection; patients must have had histologic verification of malignancy at original diagnosis or relapse Part C: Patients with recurrent or refractory high grade glioma (WHO grade III/IV) and requiring surgical resection (excluding DIPG and disseminated tumors), who in the opinion of treating physicians, are medically stable to receive 2 doses of selinexor (8-10 days of treatment) before undergoing surgery without compromising the success of the procedure; note that if, in the opinion of treating physicians, current symptoms necessitate surgery before 2 doses will be able to be received, surgery should not be delayed to administer selinexor, and the patient would be ineligible for protocol therapy Disease status: Part A: Patients must have either measurable or evaluable disease Parts B and C: Patients must have measurable disease on imaging 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 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 Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea) Hematopoietic growth factors: 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 Biologic (anti-neoplastic agent): 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 Immunotherapy: At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines 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 External beam radiation therapy (XRT): At least 14 days after local palliative XRT (small port); at least 150 days must have elapsed if prior total body irradiation (TBI), craniospinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation Stem cell infusion without TBI: No evidence of active graft vs. host disease and at least 56 days must have elapsed after transplant or stem cell infusion Patients must not have received prior exposure to selinexor 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) * Hemoglobin >= 8.0 g/dL at baseline (may receive red blood cell [RBC] transfusions) Patients with known bone marrow metastatic disease will be eligible for study if 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 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study; if dose-limiting hematologic toxicity is observed, all subsequent patients enrolled on Part A 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: =< 0.6 mg/dL (patients age 1 to < 2 years) =< 0.8 mg/dL (patients age 2 to < 6 years) =< 1 mg/dL (patients age 6 to < 10 years) =< 1.2 mg/dL (patients age 10 to < 13 years) =< 1.4 mg/dL (female patients age >= 13 years) =< 1.5 mg/dL (male patients age 13 to < 16 years) =< 1.7 mg/dL (male patients age >= 16 years) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x ULN = 135 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L Serum albumin >= 2 g/dL Serum amylase =< 1.5 x ULN Serum lipase =< 1.5 x ULN Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled Patients must be able to swallow tablets whole Part C: Archived paraffin-embedded tissue (20 unstained slides or a tumor block) from a prior resection must be available as a control for correlative studies; if tissue blocks or slides are unavailable, the study chair must be notified prior to enrollment 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, since there is yet no available information regarding human fetal or teratogenic toxicities; based on its mechanism of action and findings in animals, selinexor may cause fetal harm when administered to a pregnant woman; pregnancy tests must be obtained in girls who are post-menarchal; males with female partners of reproductive potential or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control- including a medically accepted barrier method of contraceptive method (e.g., male or female condom) for the entire period in which they are receiving protocol therapy and for at least 1 week following their last dose of study drug; abstinence is an acceptable method of birth control Concomitant medications Corticosteroids: 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 Investigational drugs: Patients who are currently receiving another investigational drug are not eligible Anti-cancer agents: Patients who are currently receiving other anti-cancer agents 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 Patients with body mass index (BMI) < 3rd percentile for age, as defined by WHO criteria for patients 1-2 years of age and Centers for Disease Control and Prevention (CDC) criteria for patients > 2 years of age, are not eligible Patients with grade 3 ataxia or grade >1 extrapyramidal movement disorder are not eligible Patients with known macular degeneration, uncontrolled glaucoma, or cataracts are not eligible
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Glade-Bender
Organizational Affiliation
COG Phase I Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UCSF Medical Center-Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Children's Healthcare of Atlanta - Egleston
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Lurie Children's Hospital-Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
C S Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Minnesota/Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Saint Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gliomas

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