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Bruton's Tyrosine Kinase (BTK) Inhibitor
Ibrutinib + Radiation + Temozolomide for Glioblastoma
Phase 1
Waitlist Available
Led By David Peereboom, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Arm 1: Supratentorial unmethylated MGMT glioblastoma
Arm 1: Patient with any surgery more than stereotactic biopsy
Must not have
Use of specific anticoagulants
Serious concurrent infection or illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the safety of combining ibrutinib with radiation at different dose levels in people with glioblastoma that has not been methylated.
Who is the study for?
This trial is for adults with newly diagnosed glioblastoma, specifically those with unmethylated MGMT tumors or methylated MGMT tumors. Participants must be in good physical condition (Karnofsky performance ≥ 70%), not pregnant, and willing to use birth control. They should have no serious concurrent illnesses, bleeding disorders, or recent surgeries and cannot be on certain medications that affect the immune system.
What is being tested?
The trial tests the safety of combining a drug called Ibrutinib with radiation therapy at different doses for patients with unmethylated MGMT glioblastoma. It also examines how well Ibrutinib works alongside Temozolomide (TMZ) and radiation in patients with methylated MGMT glioblastoma.
What are the potential side effects?
Possible side effects include increased risk of infection due to immune suppression, bleeding issues related to blood clotting problems, liver function changes, heart rhythm abnormalities, fatigue from anemia or other blood cell count changes, and potential allergic reactions to medication components.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a specific type of brain tumor that is above the cerebellum and lacks a certain DNA marker.
Select...
I have had surgery beyond a simple biopsy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am taking certain blood thinners.
Select...
I do not have any serious infections or illnesses.
Select...
I do not have an ongoing, untreated infection.
Select...
I've had brain surgery, radiation, and TMZ treatment for my tumor.
Select...
I have a serious liver condition.
Select...
I am currently taking medication to suppress my immune system.
Select...
I have not had major surgery in the last 4 weeks.
Select...
I finished treatment for an infection less than 14 days ago.
Select...
I have used ibrutinib or similar drugs before, or I am allergic to parts of the study drug.
Select...
I am currently receiving treatment for my tumor.
Select...
I have heart problems and abnormal heart test results.
Select...
I am taking medication that affects liver enzyme levels.
Select...
I have a known bleeding disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
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 ibrutinib
Secondary study objectives
Length of time of overall survival
Number of patients who experience adverse events
Number of patients with Progression Free Survival (PFS)
Side effects data
From 2022 Phase 3 trial • 201 Patients • NCT0305344037%
Diarrhoea
32%
Upper respiratory tract infection
29%
Muscle spasms
28%
Contusion
24%
Arthralgia
24%
Hypertension
22%
Oedema peripheral
22%
Anaemia
21%
Epistaxis
20%
Cough
19%
Rash
19%
Fatigue
18%
Back pain
18%
Atrial fibrillation
17%
Urinary tract infection
16%
Neutropenia
16%
Thrombocytopenia
15%
Nausea
15%
Headache
15%
Vomiting
14%
Pneumonia
14%
Dizziness
13%
Haematuria
12%
Peripheral swelling
12%
Pyrexia
12%
Constipation
11%
Localised infection
10%
Pain in extremity
10%
Onychoclasis
10%
Fall
10%
Oropharyngeal pain
10%
Lower respiratory tract infection
10%
Sinusitis
10%
Palpitations
9%
Insomnia
9%
Nasopharyngitis
9%
Hyperuricaemia
9%
Dyspnoea
9%
Haematoma
8%
Skin laceration
8%
Paraesthesia
7%
Dyspepsia
7%
Dry skin
7%
Cellulitis
7%
Conjunctivitis
7%
Skin infection
7%
Iron deficiency
7%
Anxiety
7%
Rhinitis
6%
Cataract
6%
Conjunctival haemorrhage
6%
Pruritus
6%
Hypokalaemia
6%
Syncope
6%
Vision blurred
6%
Abdominal pain
6%
Abdominal pain upper
6%
Nail infection
6%
Neck pain
6%
Purpura
6%
Asthenia
5%
Abdominal discomfort
5%
Gingival bleeding
5%
Chest pain
5%
Mouth ulceration
5%
Stomatitis
5%
Onychomycosis
5%
Rhinorrhoea
5%
Actinic keratosis
5%
Dermatitis
5%
Petechiae
5%
Influenza like illness
5%
COVID-19
5%
Gastroenteritis
5%
Tooth infection
5%
Limb injury
5%
Squamous cell carcinoma of skin
5%
Peripheral sensory neuropathy
5%
Rosacea
5%
Increased tendency to bruise
5%
Gout
5%
Basal cell carcinoma
5%
Folliculitis
5%
Oral herpes
5%
Gastrooesophageal reflux disease
4%
Retinal haemorrhage
4%
Angina pectoris
4%
Dry mouth
4%
Vertigo
4%
Haemorrhoids
4%
Ecchymosis
4%
Sepsis
4%
Chills
4%
Bronchitis
4%
Furuncle
4%
Joint injury
4%
Blood alkaline phosphatase increased
4%
Neutrophil count decreased
4%
Decreased appetite
4%
Joint swelling
4%
Depression
4%
Productive cough
4%
Skin ulcer
4%
Atrial flutter
4%
Hyperglycaemia
4%
Herpes zoster
3%
Abdominal distension
3%
Sinus bradycardia
3%
Inguinal hernia
3%
Tinnitus
3%
Dysphagia
3%
Dry eye
3%
Dysuria
3%
Bladder transitional cell carcinoma
3%
Rotator cuff syndrome
3%
Pollakiuria
3%
Hypoalbuminaemia
3%
Osteoporosis
3%
Erythema
3%
Acute myocardial infarction
3%
Malaise
3%
Cystitis
3%
Alanine aminotransferase increased
3%
Gamma-glutamyltransferase increased
3%
Musculoskeletal chest pain
3%
Seborrhoeic keratosis
3%
Neuralgia
3%
Benign prostatic hyperplasia
3%
Dyspnoea exertional
3%
Nasal congestion
3%
Pneumonitis
3%
Psoriasis
3%
Skin fissures
3%
Skin lesion
3%
Laryngitis
3%
Respiratory tract infection
3%
Bradycardia
3%
Acute kidney injury
3%
Wound infection
3%
Myalgia
3%
Skin toxicity
3%
Ear infection
3%
Paronychia
3%
Osteoarthritis
3%
Pericarditis
3%
Sciatica
3%
Ocular hyperaemia
3%
Nail disorder
2%
Pleural effusion
2%
Rectal haemorrhage
2%
Cholecystitis
2%
COVID-19 pneumonia
2%
Drug withdrawal syndrome
2%
Seasonal allergy
2%
Vitamin D deficiency
2%
Rash maculo-papular
2%
Hypotension
2%
Death
2%
Loss of consciousness
1%
Post procedural haemorrhage
1%
Laryngeal oedema
1%
Lumbar vertebral fracture
1%
Stress fracture
1%
Haemolytic anaemia
1%
Haemorrhagic disorder
1%
Viral infection
1%
Wound infection staphylococcal
1%
Cardiac failure acute
1%
Wheezing
1%
Colitis
1%
Oral blood blister
1%
Upper gastrointestinal haemorrhage
1%
Drug-induced liver injury
1%
Bacterial sepsis
1%
Brain abscess
1%
Device related infection
1%
Gastrointestinal infection
1%
Neurocryptococcosis
1%
Septic shock
1%
Streptococcal bacteraemia
1%
Femoral neck fracture
1%
Femur fracture
1%
Subdural haematoma
1%
Lethargy
1%
Subarachnoid haemorrhage
1%
Chronic kidney disease
1%
Urinary bladder haemorrhage
1%
Prostatitis
1%
Acute pulmonary oedema
1%
Hyponatraemia
1%
Muscular weakness
1%
Rash erythematous
1%
Hyperviscosity syndrome
1%
Melaena
1%
Clostridium difficile infection
1%
Post procedural sepsis
1%
Pyelonephritis
1%
Cerebrovascular accident
1%
Respiratory disorder
1%
Lymphadenopathy
1%
Streptococcal sepsis
1%
Amyloidosis
1%
Influenza
1%
Pneumonia viral
1%
Coronary artery disease
1%
Pericardial haemorrhage
1%
Urosepsis
1%
Spinal stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Ibrutinib
Arm B: Zanubrutinib
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Unmethylated MGMT GlioblastomaExperimental Treatment2 Interventions
Every patient gets ibrutinib + radiation over 6 weeks. Patients will undergo a 4-week break and then Ibrutinib treatment will continue until disease progression, intolerable toxicity, or death.
Group II: Methylated MGMT GlioblastomaExperimental Treatment3 Interventions
Every patient gets ibrutinib + radiation + daily Temozolomide (TMZ) (75mg/m2) for 6 weeks. Patients will undergo a 4-week break and patients will then receive daily ibrutinib and adjuvant Temozolomide for Days 1-5 of a 28-day cycle of temozolomide for 6 cycles. The temozolomide will continue until disease progression, intolerable toxicity, or death or maximum of 6 cycles. Ibrutinib treatment will continue until disease progression, intolerable toxicity, or death.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide (TMZ)
2005
Completed Phase 3
~760
Radiation
2003
Completed Phase 2
~780
Ibrutinib
2014
Completed Phase 4
~2060
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
468 Previous Clinical Trials
33,400 Total Patients Enrolled
David Peereboom, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
9 Previous Clinical Trials
368 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking certain blood thinners.I do not have any serious infections or illnesses.I have no other cancers, except for allowed exceptions.I do not have an ongoing, untreated infection.I've had brain surgery, radiation, and TMZ treatment for my tumor.I have a serious liver condition.I am currently taking medication to suppress my immune system.I have a specific type of brain tumor that is above the cerebellum and lacks a certain DNA marker.I have not had major surgery in the last 4 weeks.I have not received any live vaccines in the last 4 weeks.I finished treatment for an infection less than 14 days ago.I have had surgery beyond a simple biopsy.I meet all criteria for Arm 1 except my glioblastoma is MGMT methylated.I can care for myself but may not be able to do active work.My blood counts and organ functions are within normal ranges.I am a woman and my pregnancy test is negative.I have no other cancers except for allowed exceptions.I've had a Gadolinium MRI or contrast CT scan within the last 28 days.I have used ibrutinib or similar drugs before, or I am allergic to parts of the study drug.I am currently receiving treatment for my tumor.I have heart problems and abnormal heart test results.I am taking medication that affects liver enzyme levels.I have a known bleeding disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Unmethylated MGMT Glioblastoma
- Group 2: Methylated MGMT Glioblastoma
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.