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EGFR inhibitor
Personalized Treatment for Recurrent Glioblastoma
Phase < 1
Recruiting
Led By Paula de Robles
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult participants, male and female, aged ≥18 with pathologically confirmed IDH-wild type glioblastoma, first or second progression of the tumor, amenable to resection, and after initial treatment with radiation therapy and temozolomide.
Performance status: ECOG ≤2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of study drug administration until date of radiographic confirmed progression (approximately 2 years)
Awards & highlights
Study Summary
This trial will study a personalized treatment for recurrent glioblastoma, and will aim to see if it is feasible to conduct a larger trial.
Who is the study for?
Adults over 18 with recurrent glioblastoma, not breastfeeding or pregnant, and willing to use contraception. Participants must have a performance status allowing daily activity (ECOG ≤2), be able to undergo brain MRIs, and have tumors suitable for resection. Excluded are those with certain heart, liver, kidney issues; gastrointestinal disorders; active infections; recent investigational drug use; other cancer treatments; or known psychiatric/substance abuse issues.Check my eligibility
What is being tested?
The trial is testing a personalized treatment regimen based on the genetic profile of each patient's tumor using drugs like Everolimus, Olaparib, Dasatinib, Afatinib, Palbociclib. It's an early-stage study to see if it's feasible to conduct larger trials and gather initial data on these interventions in patients with recurrent glioblastoma.See study design
What are the potential side effects?
Potential side effects may include fatigue, nausea, diarrhea (specifically from Afatanib), blood cell count changes leading to increased infection risk or bleeding problems. There could also be liver function changes and potential heart rhythm abnormalities due to abnormal ECG readings.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult with a specific type of brain tumor that has come back after initial treatments.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I am a woman over 45 and have not had a period for 12 months due to menopause.
Select...
I am not currently breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of study drug administration until date of radiographic confirmed progression (approximately 2 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of study drug administration until date of radiographic confirmed progression (approximately 2 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Success rate of personalized GBM treatment based on molecular characterization of recurrent tumor
Secondary outcome measures
Overall survival (OS)
Progression free survival (PFS)
Quality of Life (QoL) EORTC QLQ BN-20
+1 moreOther outcome measures
Correlation of genomic and expression profiling of tissue and organoid with the organoid's best drug response
Genomic and expression profiling
Organoid drug response
Side effects data
From 2022 Phase 2 trial • 54 Patients • NCT0302304626%
Febrile neutropenia
17%
Sepsis
9%
Mucositis oral
4%
Upper gastrointestinal hemorrhage
4%
Intracranial hemorrhage
4%
Hypotension
4%
Hypertension
4%
Enterocolitis
2%
Atrial fibrillation
2%
Lower gastrointestinal hemorrhage
2%
Delirium
2%
Oropharyngeal pain
2%
Gastric hemorrhage
2%
Abdominal pain
2%
Diarrhea
2%
Fungemia
2%
Typhlitis
2%
Myocardial infarction
2%
Fibrinogen decreased
2%
Endophthalmitis
2%
Multi-organ failure
2%
Kidney infection
2%
Peripheral motor neuropathy
2%
Hypoxia
2%
Sinus bradycardia
2%
Edema limbs
2%
Small intestinal obstruction
2%
Aspiration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy)
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment5 Interventions
Patients will receive one of the 5 study drugs based on their recurrent tumor mutation profile and their recurrent organoid response to these drugs:
Afatinib
Dasatinib
Palbociclib
Everolimus
Olaparib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Everolimus
FDA approved
Olaparib
FDA approved
Dasatinib
FDA approved
Afatinib
FDA approved
Palbociclib
FDA approved
Find a Location
Who is running the clinical trial?
Tom Baker Cancer CentreOTHER
29 Previous Clinical Trials
8,845 Total Patients Enrolled
1 Trials studying Glioblastoma
59 Patients Enrolled for Glioblastoma
AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,202 Total Patients Enrolled
7 Trials studying Glioblastoma
399 Patients Enrolled for Glioblastoma
Paula de RoblesPrincipal InvestigatorTom Baker Cancer Centre
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to give consent by myself.I am an adult with a specific type of brain tumor that has come back after initial treatments.I have a rare genetic issue with processing certain sugars.I have COVID-19 and haven't recovered before starting the study drug.I am currently taking medication that strongly affects how drugs are processed in my body.I agree not to donate sperm for 6 months during the study.I agree to use two effective birth control methods if I can have children.I recently had a bacterial infection and haven't finished my antibiotics.I have severe or recent stomach issues with diarrhea.I do not have active hepatitis B or C, nor HIV.I can take care of myself but might not be able to do heavy physical work.I choose not to have sex as my form of birth control.I am a woman over 45 and have not had a period for 12 months due to menopause.I am not currently breastfeeding.I have a history of lung scarring or fibrosis.I have severe liver problems.I am not pregnant and will follow the contraception guidelines.I have fluid buildup in the lining of my lungs.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
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 it still possible to apply for participation in this scientific trial?
"As indicated on the clinicaltrials.gov website, this medical experiment is not presently in need of participants; however, it was initially posted on September 1st 2022 and last edited June 24th 2022. Though no longer recruiting for volunteers, there are currently 1395 other studies that require candidates."
Answered by AI
What is the intention of this investigation?
"The primary objective of this clinical trial, assessed over a two-year period from initial consent to the end of follow up, is determining the efficacy of personalized GBM treatment based on molecular characterization. Secondary outcomes encompass Quality of Life (QoL) EORTC QLQ BN-20 - a 4 scale module with multiple items and single items rated on a 4 point Likert Scale; Progression free survival (PFS), calculated as time between administration and confirmation by radiographic assessment; and Quality of Life (QoL) EORTC QLQ C30 – an overall quality questionnaire scored on a 7 point"
Answered by AI
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