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Selinexor + Chemotherapy + Radiation for Brain Cancer
Phase 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My diagnosis is glioblastoma or gliosarcoma (grade IV astrocytoma).
Select...
I am eligible for specific radiation therapy and temozolomide treatment.
Select...
I am mostly able to take care of myself.
Select...
I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ dlt
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~dlt
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MTD
Secondary outcome measures
Dose-limiting toxicities
Side effects data
From 2017 Phase 2 trial • 116 Patients • NCT0202598578%
Decreased Appetite
65%
Fatigue
65%
Nausea
61%
Vomiting
57%
Weight Decreased
48%
Anaemia
43%
Thrombocytopenia
35%
Hypokalaemia
35%
Vision Blurred
30%
Asthenia
30%
Diarrhoea
26%
Constipation
22%
Dizziness
22%
Dysgeusia
22%
Hyponatraemia
22%
Hypomagnesaemia
17%
Dehydration
17%
Peripheral Sensory Neuropathy
13%
Malaise
13%
Dyspnoea
13%
Neutropenia
13%
Cystitis
13%
Back Pain
9%
Ear Discomfort
9%
Face Oedema
9%
Oedema Peripheral
9%
Pulmonary Embolism
9%
Syncope
9%
Cough
9%
Confusional State
9%
Auditory Disorder
9%
General Physical Health Deterioration
9%
Deep Vein Thrombosis
9%
Urinary Tract Infection
9%
Hyperglycaemia
9%
Pain In Extremity
9%
Hypotension
9%
Paraesthesia
4%
Infection
4%
Visual Impairment
4%
Insomnia
4%
Pneumonia
4%
Cataract
4%
Varicella Zoster Virus Infection
4%
Oropharyngeal Pain
4%
Vertigo
4%
Urosepsis
4%
Pyrexia
4%
Supraventricular Tachycardia
4%
Femoral Neck Fracture
4%
Depression
4%
Polyurea
4%
Hot Flush
4%
Headache
4%
Gait Disturbance
4%
Abdominal Pain
4%
Abdominal Distension
4%
Stomatitis
4%
Ascites
4%
Dry Mouth
4%
Abdominal Pain Lower
4%
Oral Candidiasis
4%
Arthralgia
4%
Vaginal Haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW
Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW
Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW
Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW
Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1/Experimental therapyExperimental Treatment3 Interventions
Selinexor with temozolomide and radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1930
Selinexor
2020
Completed Phase 2
~1360
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,924,310 Total Patients Enrolled
322 Trials studying Glioblastoma
23,091 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have HIV due to potential treatment complications.I can take oral medication without issues like vomiting or severe diarrhea.I haven't had significant bleeding or coagulation issues in the last month.My diagnosis is glioblastoma or gliosarcoma (grade IV astrocytoma).My liver function tests are within the allowed range for the study.I have had previous treatments for brain cancer, including radiation, chemotherapy, or other specific therapies.I am allergic to medications similar to selinexor or temozolomide.I am not pregnant or breastfeeding.I am eligible for specific radiation therapy and temozolomide treatment.I or my legal representative can understand and are willing to sign the consent form.I do not have any active, uncontrolled infections.I am mostly able to take care of myself.I am older than 18 years.I do not have an active hepatitis A, B, or C infection.I had surgery or a biopsy less than 8 weeks ago.My blood counts meet the required levels for neutrophils, platelets, and hemoglobin.I do not have a condition that makes me overly sensitive to radiation.
Research Study Groups:
This trial has the following groups:- Group 1: 1/Experimental therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being recruited for this experimental research?
"Affirmative, the information hosted on clinicaltrials.gov indicates that this medical trial is currently recruiting participants. It was established on July 7th 2020 and recently updated November 24th 2022 with a goal of enrolling 24 individuals at one site."
Answered by AI
Are the doors of this research project currently open to participants?
"Yes, the clinicaltrials.gov portal confirms that this investigation is currently enrolling participants. Initially posted on July 7th 2020 and last amended November 24th 2022, it requires the recruitment of 24 subjects from a single location."
Answered by AI
Has Selinexor been endorsed by the FDA?
"As this is an early stage investigation, data confirming the safety and efficacy of Selinexor has yet to be determined. Thus, our team at Power gave it a rating of 1 on a scale from 1 - 3."
Answered by AI
What primary benefit does Selinexor provide patients?
"Selinexor is a viable therapy for treating nitrosourea refractory diseases, as well as advanced mycosis fungoides and multiple myeloma that have not responded to other treatment methods."
Answered by AI
Are there any prior experiments involving Selinexor that have been conducted?
"Currently, 252 trials are being conducted to investigate the efficacy of Selinexor with 27 at Phase 3. Most tests for this medication occur in Seoul, Songpa; however, over 5654 locations around the world offer these clinical studies."
Answered by AI
Is this a pioneering medical research endeavor?
"Since 2002, Selinexor has been subject to numerous clinical trials. The initial study was commissioned by Schering-Plough and included 60 patients. Following a successful Phase 2 approval process, this drug is now being administered in 252 live studies across 1025 cities and 42 countries worldwide."
Answered by AI
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