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Selective Inhibitor of Nuclear Export (SINE)

Selinexor for Pediatric Solid Tumors or Brain Tumors

Phase 1
Waitlist Available
Led By Julia Glade-Bender
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with recurrent or refractory high grade glioma (WHO grade III/IV) are eligible if they meet specific criteria
Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years 11 months
Awards & highlights

Study Summary

This trial studies selinexor to learn if it can help to shrink tumors in young patients with solid tumors or CNS tumors.

Who is the study for?
This trial is for young patients with solid tumors or high-grade gliomas that have returned or are not responding to treatment. They must be able to swallow tablets, have a body surface area (BSA) >= 0.84 m^2, and meet specific blood count and organ function criteria. Not eligible if they've had selinexor before, are pregnant/breastfeeding, on investigational drugs, have uncontrolled infections or certain medical conditions.Check my eligibility
What is being tested?
The trial is testing the safety and optimal dosage of a chemotherapy drug called Selinexor in younger patients. This medication aims to stop tumor growth by killing cells or preventing them from dividing and spreading.See study design
What are the potential side effects?
Selinexor may cause side effects such as nausea, vomiting, fatigue, loss of appetite, weight loss, diarrhea, changes in blood counts leading to increased risk of infection or bleeding problems; neurological symptoms like dizziness; mood changes; liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition is a high-grade, aggressive brain tumor that has returned or didn't respond to treatment.
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I am mostly able to care for myself and carry out daily activities.
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My body surface area is at least 0.84 square meters.
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I have never been treated with selinexor.
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My current condition cannot be cured with existing treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years 11 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years 11 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Drug Concentration Curve of Selinexor
Number of Adverse Events of Selinexor
Number of Dose Limiting Toxicities of Selinexor
Secondary outcome measures
Antitumor Effect of Selinexor
Pharmacodynamics of Selinexor
Pharmacodynamics of Selinexor in High-grade Glioma (HGG) Patients
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (selinexor)Experimental Treatment2 Interventions
Patients receive selinexor PO on either a twice weekly (days 1, 3, 8, 10, 15, 17) or once weekly (days 1, 8, 15, and 22) schedule. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
2020
Completed Phase 2
~1360

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
456 Previous Clinical Trials
239,727 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,708 Previous Clinical Trials
40,932,670 Total Patients Enrolled
Julia Glade-BenderPrincipal InvestigatorCOG Phase I Consortium
2 Previous Clinical Trials
61 Total Patients Enrolled

Media Library

Selinexor (Selective Inhibitor of Nuclear Export (SINE)) Clinical Trial Eligibility Overview. Trial Name: NCT02323880 — Phase 1
Brain Tumor Research Study Groups: Treatment (selinexor)
Brain Tumor Clinical Trial 2023: Selinexor Highlights & Side Effects. Trial Name: NCT02323880 — Phase 1
Selinexor (Selective Inhibitor of Nuclear Export (SINE)) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02323880 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How secure are the outcomes of this pharmaceutical research for those who participate?

"Due to the limited information available on this pharmacological study, it received a score of 1 in terms of safety efficacy. This is indicative that we are currently at Phase 1 trial stage."

Answered by AI

Are there any openings available for patient participation in this trial?

"This trial is not currently looking for participants; the posting was published on October 5th, 2015 and its most recent update occurred on October 7th, 2022. If you are searching for other trials, there are presently 5594 active glioma studies and 48 Pharmacological Studies with enrollment available to patients."

Answered by AI

Is there an age limit for participants in this clinical research project?

"In order to fit the criteria of this medical trial, patients must be between 12 months and 21 years old."

Answered by AI

Has this clinical trial been attempted before?

"Since 2014, research on Pharmacological Study has been ongoing. Karyopharm Therapeutics Inc initially sponsored the initial investigation which was conducted in that year and involved 16 participants. After Phase 1 drug approval had been established, 48 trials began to take place internationally spanning 28 different countries with a collective 259 sites of study."

Answered by AI

Could you provide me with information on how to become a participant of this trial?

"This medical trial is open to 68 individuals with glioma aged between 12 Months and 21. Eligible patients must comply with the following parameters: Part B: Patients displaying recurrent or refractory high-grade glioma (WHO grade III/IV) not mandating surgical resection, that have had histological authentication of their malignancy at initial diagnosis or relapse; neurological conditions in people suffering from CNS tumors should be stable for a minimum duration of 7 days before enrolment; paralysis preventing walking, but permitting wheelchair use will still qualify as ambulatory regarding performance score assessment criteria.Part A: Recurrent/refractory"

Answered by AI

Are there any other Pharmacological Study that have been conducted prior to this?

"The Pharmacological Study was first conducted in 2014 at Children's Healthcare of Atlanta and has since completed 201 trials. Currently, 48 studies are ongoing with the majority located in Memphis, Tennessee."

Answered by AI

How many individuals are being administered treatment in this clinical research study?

"This clinical trial is no longer in the recruitment phase, with its last update on October 7th 2022. However, if you are looking for alternative studies, there are currently 5594 research projects recruiting patients diagnosed with glioma and 48 Pharmacological Studies that are accepting participants."

Answered by AI

What are the key goals of this medical experiment?

"Over a two-day period, this trial seeks to measure the maximum serum concentration of selinexor as its primary outcome. As secondary objectives, researchers aim to ascertain antitumor effects, pharmacodynamics in HGG patients, and radiographic response by study part schema and dose level."

Answered by AI

How many centers are responsible for managing this experiment?

"This clinical trial is recruiting patients from Saint Jude's Children Research Hospital in Memphis, the Children's Hospital of Los Angeles and Lurie Childrens' Hospital-Chicago. Moreover, there are 20 other sites offering enrollment into this study."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
65+
What site did they apply to?
UCSF Medical Center-Mission Bay
What portion of applicants met pre-screening criteria?
Met criteria
~6 spots leftby May 2025