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Selinexor + Chemotherapy + Radiation for Brain Cancer

Phase 1
Waitlist Available
Led By Kevin A Camphausen, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histological diagnosis: Pathologically confirmed glioblastoma or gliosarcoma (including astrocytoma, grade IV)
Patients must be eligible for definitive external beam radiotherapy and temozolomide
Must not have
HIV patients are not eligible because of their immunocompromised status and overlap of side effects between HAART therapy and radiation therapy
Patients must not have significantly diseased or obstructed gastrointestinal tract malabsorption, uncontrolled vomiting or diarrhea, or inability to swallow oral medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from initiation of treatment on protocol to date of death due to any cause, approximately months.
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if the drug selinexor, when combined with chemotherapy and radiation, might help treat brain cancer.

Who is the study for?
Adults over 18 with newly diagnosed glioblastoma or gliosarcoma who haven't had chemo or radiation, can undergo radiotherapy and temozolomide treatment, have a certain level of physical function (KPS >70), and agree to use contraception. Excluded are those with uncontrolled infections, severe liver issues, pregnant/nursing women, HIV patients, prior brain RT or chemotherapy for glioma.
What is being tested?
The trial is testing the highest dose of Selinexor that's tolerable when combined with Temozolomide and generic Radiation Therapy in treating new cases of brain cancer. Participants will receive daily radiation for up to 6 weeks while taking oral Selinexor weekly and Temozolomide daily during this period.
What are the potential side effects?
Selinexor may cause nausea, vomiting, fatigue, loss of appetite; blood count changes; potential harm to unborn babies hence contraception requirement. Temozolomide might lead to similar side effects including hair loss and headache.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My diagnosis is glioblastoma or gliosarcoma (grade IV astrocytoma).
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I am eligible for specific radiation therapy and temozolomide treatment.
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I am mostly able to take care of myself.
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have HIV due to potential treatment complications.
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I can take oral medication without issues like vomiting or severe diarrhea.
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I am allergic to medications similar to selinexor or temozolomide.
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I am not pregnant or breastfeeding.
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I do not have any active, uncontrolled infections.
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I do not have an active hepatitis A, B, or C infection.
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I do not have a condition that makes me overly sensitive to radiation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initiation of treatment on protocol to progression as per rano criteria or death due to disease progression, approximately months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from initiation of treatment on protocol to progression as per rano criteria or death due to disease progression, approximately months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose (MTD) of Selinexor
Secondary study objectives
Dose-limiting Toxicities (DLT) Effects on Neurocognition
Dose-limiting Toxicities Effects on Quality of Life (QOL)
Dose-limiting Toxicities of Selinexor to Concurrent Radiation Therapy and Temozolomide Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) and Radiation Therapy Oncology Group (RTOG)
Other study objectives
Number of Participants With Serious and/or Non-Serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Overall Survival (OS)
Progression Free Survival (PFS)

Side effects data

From 2022 Phase 3 trial • 402 Patients • NCT03110562
43%
Weight decreased
29%
Cough
29%
Thrombocytopenia
29%
Decreased appetite
29%
Nausea
21%
Fatigue
21%
Anaemia
21%
Constipation
21%
Diarrhoea
14%
Neuropathy peripheral
14%
Oedema peripheral
14%
Pneumonia
14%
Paraesthesia
14%
Cataract
14%
Vomiting
14%
Headache
7%
Urinary tract infection
7%
Asthma
7%
Disturbance in attention
7%
Respiratory syncytial virus infection
7%
Neutropenia
7%
Peripheral swelling
7%
Mental status changes
7%
Lower respiratory tract infection
7%
Hyperthyroidism
7%
Back pain
7%
Pain in extremity
7%
Basal cell carcinoma
7%
Hyponatraemia
7%
Skin lesion
7%
Oropharyngeal pain
7%
Pyrexia
7%
Cardiac failure
7%
Hepatitis
7%
Pharyngitis
7%
Hypophagia
7%
Pollakiuria
7%
Bronchiectasis
7%
Non-cardiac chest pain
7%
C-reactive protein increased
7%
Taste disorder
7%
Haemorrhagic transformation stroke
7%
Abdominal pain
7%
Insomnia
7%
Dyspepsia
7%
Haemoglobin decreased
7%
Infection
7%
Hyperglycaemia
7%
Toothache
7%
Ecchymosis
7%
Upper respiratory tract infection
7%
Nasopharyngitis
7%
Fungal skin infection
7%
Viral infection
7%
Hypertension
7%
Muscular weakness
100%
80%
60%
40%
20%
0%
Study treatment Arm
SdX Arm: Selinexor + Dexamethasone
SVdX Arm: Selinexor + Bortezomib + Dexamethasone
SVd Arm: Selinexor + Bortezomib + Dexamethasone
Vd Arm: Bortezomib + Dexamethasone

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1/Experimental Therapy - Selinexor with Temozolomide and RadiationExperimental Treatment7 Interventions
Selinexor with temozolomide and radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
2020
Completed Phase 3
~1730
Temozolomide
2010
Completed Phase 3
~1880

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,907 Previous Clinical Trials
41,012,133 Total Patients Enrolled
330 Trials studying Glioblastoma
23,370 Patients Enrolled for Glioblastoma
Kevin A Camphausen, M.D.Principal InvestigatorNational Cancer Institute (NCI)
14 Previous Clinical Trials
3,257 Total Patients Enrolled
2 Trials studying Glioblastoma
217 Patients Enrolled for Glioblastoma

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04216329 — Phase 1
Glioblastoma Research Study Groups: 1/Experimental Therapy - Selinexor with Temozolomide and Radiation
Glioblastoma Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT04216329 — Phase 1
Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04216329 — Phase 1
~2 spots leftby Nov 2025
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