Your session is about to expire
← Back to Search
Alkylating Agent
Chemo-immunotherapy for Pediatric Brain Cancer
Phase 1
Recruiting
Led By Theodore S. Johnson, MD, PhD
Research Sponsored by Theodore S. Johnson
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No concurrent anti-neoplastic therapy other than that described by this clinical study protocol (GCC2020) may be administered with the intent to treat the patient's malignancy while they remain enrolled on this study
Adequate renal function: Creatinine clearance (CLcr) > 25 mL/min (by calculated methods) AND Creatinine ≤ 1.5-times upper limit of age-adjusted normal for age of patient
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a combination of two drugs to see if they are more effective than one of the drugs alone in treating cancer.
Who is the study for?
This trial is for young people aged 12-25 with relapsed or refractory primary brain cancer, such as glioblastoma or medulloblastoma. They must be able to swallow pills, have no curative treatment options left, and not be pregnant. Participants need proper kidney and liver function, controlled seizures if present, and a certain level of physical ability.Check my eligibility
What is being tested?
The study tests the combination of Ibrutinib (BTK-inhibitor) with Indoximod (IDO-inhibitor) alongside chemotherapy drugs Cyclophosphamide and Etoposide in pediatric brain cancer patients. It aims to find the safest dose that enhances immune response against tumors without severe overlapping toxicity.See study design
What are the potential side effects?
Potential side effects include those common to chemotherapy like nausea, fatigue, hair loss; plus specific risks from Ibrutinib such as bleeding problems or heart rhythm issues; and Indoximod may cause immune-related adverse effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not receiving any cancer treatments other than what this study offers.
Select...
My kidney function is within the required range for the trial.
Select...
My brain cancer has worsened or not responded to treatment, and there are no standard cures left for me.
Select...
I can do most activities but need help with some.
Select...
My blood tests show I have enough neutrophils, platelets, and hemoglobin.
Select...
I have been treated with the chemotherapy drugs listed in this study before.
Select...
My current disease was confirmed active by an MRI with contrast.
Select...
My liver tests are within the normal range, or any high bilirubin is due to Gilbert's syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of regimen-limiting toxicity (RLT)
Objective Response Rate (ORR)
Secondary outcome measures
Adverse events (AEs)
Complete Response Rate (CRR)
Frequency of cycle delays for toxicity
+5 moreSide 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%
Nasopharyngitis
9%
Hyperuricaemia
9%
Insomnia
9%
Dyspnoea
9%
Haematoma
8%
Skin laceration
8%
Paraesthesia
7%
Dry skin
7%
Dyspepsia
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%
Actinic keratosis
5%
Dermatitis
5%
Stomatitis
5%
Gingival bleeding
5%
Rhinorrhoea
5%
Petechiae
5%
Mouth ulceration
5%
Onychomycosis
5%
Abdominal discomfort
5%
Chest pain
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%
Haemorrhoids
4%
Vertigo
4%
Ecchymosis
4%
Sepsis
4%
Angina pectoris
4%
Retinal haemorrhage
4%
Dry mouth
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%
Tinnitus
3%
Abdominal distension
3%
Dysuria
3%
Pollakiuria
3%
Dry eye
3%
Osteoporosis
3%
Erythema
3%
Bladder transitional cell carcinoma
3%
Hypoalbuminaemia
3%
Rotator cuff syndrome
3%
Inguinal hernia
3%
Acute myocardial infarction
3%
Sinus bradycardia
3%
Dysphagia
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%
Rectal haemorrhage
2%
Cholecystitis
2%
COVID-19 pneumonia
2%
Pleural effusion
2%
Drug withdrawal syndrome
2%
Seasonal allergy
2%
Vitamin D deficiency
2%
Rash maculo-papular
2%
Hypotension
2%
Death
2%
Loss of consciousness
1%
Haemolytic anaemia
1%
Wheezing
1%
Wound infection staphylococcal
1%
Viral infection
1%
Cardiac failure acute
1%
Haemorrhagic disorder
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%
Lumbar vertebral fracture
1%
Post procedural haemorrhage
1%
Stress fracture
1%
Subdural haematoma
1%
Lethargy
1%
Subarachnoid haemorrhage
1%
Chronic kidney disease
1%
Urinary bladder haemorrhage
1%
Prostatitis
1%
Acute pulmonary oedema
1%
Laryngeal 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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment RegimenExperimental Treatment4 Interventions
Patients will be treated with the 4-drug chemo-immunotherapy regimen. Cycles are a minimum of 28 days, and maximum treatment duration is 12 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Etoposide
2010
Completed Phase 3
~2440
Ibrutinib
2014
Completed Phase 3
~1880
Indoximod
2014
Completed Phase 2
~750
Find a Location
Who is running the clinical trial?
Theodore S. JohnsonLead Sponsor
1 Previous Clinical Trials
140 Total Patients Enrolled
Augusta UniversityOTHER
211 Previous Clinical Trials
85,031 Total Patients Enrolled
Theodore S. Johnson, MD, PhDPrincipal InvestigatorAugusta University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with lymphoma in my brain or spinal cord.I need blood thinners like warfarin.I do not have HIV, active Hepatitis B or C, or any uncontrolled infections.I am on long-term medication that strongly affects liver enzyme activity.I am not receiving any cancer treatments other than what this study offers.My kidney function is within the required range for the trial.I cannot swallow pills.My brain cancer has worsened or not responded to treatment, and there are no standard cures left for me.I have not had major surgery or unhealed wounds in the last 4 weeks.I can do most activities but need help with some.My seizures are under control with medication.I have not received any live vaccines in the last 4 weeks.I do not have serious heart problems like uncontrolled heart rhythm issues or recent heart attacks.My cancer has spread to other parts of my body.I have been treated with the chemotherapy drugs listed in this study before.My blood tests show I have enough neutrophils, platelets, and hemoglobin.My heart's electrical system has a specific irregularity.I do not have any severe illnesses that could affect my safety or interfere with the study treatment.I am receiving treatment for an active autoimmune disease.My current disease was confirmed active by an MRI with contrast.I, or my parent if I'm under 18, agree to participate in the study and understand what it involves.My liver tests are within the normal range, or any high bilirubin is due to Gilbert's syndrome.I haven't had a stroke or serious bleeding in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Regimen
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.
Is the eligibility criteria for this research still open?
"Affirmative. The particulars hosted on clinicaltrials.gov attest to the fact that this experiment, which was inaugurated on February 8th 2022, is presently searching for participants. Approximately 37 patients need to be enlisted from 1 medical centre."
Answered by AI
Am I eligible to partake in this clinical investigation?
"This investigation necessitates the enrollment of 37 young adults between 12 and 25 with a glioblastoma diagnosis. In order to qualify, applicants must pass all of the following criteria: ALT levels not exceeding 3x upper limit of normal, total bilirubin below 1.5x ULN unless caused by Gilbert's Syndrome/non-hepatic origin; MRI confirmation that tumor has grown or regrown since initial diagnosis (with & without gadolinium); ability to swallow pills; Lansky/Karnofsky performance rate ≥ 50%; creatinine clearance >25 mL/min + ≤1.5x age"
Answered by AI
To what ailments does Ibrutinib typically provide relief?
"In addition to its use in treating leukemia, ibrutinib has been demonstrated as a potential remedy for prostate cancer, lung cancers, and small cell lung cancer (SCLC)."
Answered by AI
Does this investigation accept participants over the age of thirty?
"This medical trial is only open to patients between the ages of 12 and 25. Alternatively, 568 trials are available for individuals under 18 years old, with 1658 clinical studies aimed at those over 65."
Answered by AI
Are there other investigations conducted on Ibrutinib's effectiveness?
"At present, 1130 clinical trials are underway to assess the efficacy of Ibrutinib. Of those, 221 are in phase 3. While many studies originate from Philadelphia (PA), there is a presence for this treatment across 41888 locations worldwide."
Answered by AI
What objectives are being sought through this clinical research?
"This medical trial's primary goal, evaluated over the initial three months of intervention, will be to measure Objective Response Rate (ORR). Secondary objectives include determining Complete Response Rate (CRR) by iRANO criteria; assessing whether immunotherapy causes delays in starting subsequent cycles of chemotherapy and finally recording adverse events associated with the treatment regimen."
Answered by AI
Has the FDA sanctioned Ibrutinib for therapeutic use?
"Given the lack of safety data and efficacy evidence, our team at Power awarded Ibrutinib a score of 1 on a scale from 1 to 3."
Answered by AI
How many participants are currently participating in the study?
"Affirmative. The data on clinicaltrials.gov demonstrates that this research effort, which commenced on February 8th 2022, is still recruiting participants. A total of 37 subjects need to be sourced from one medical centre."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Augusta University, Georgia Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger