Pilot Trial for Treatment of Recurrent Glioblastoma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAHS Cancer Control Alberta
About this trial
This will be a single-arm open-label prospective pilot feasibility trial recruiting 10 adult patients with recurrent glioblastoma who are assigned to receive the personalized study treatment based on the genetic profile of their recurrent GBM tumor resected at the time of surgery. It will be aimed to gather preliminary information on the study intervention and the feasibility of conducting a full-scale trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Study participant has provided informed consent prior to initiation of any study specific activities/procedures.
Adult participants, male and female, aged ≥18 who have a pathologically confirmed IDH-wild type glioblastoma, with first or second progression of the tumor, after initial treatment with radiation therapy and temozolomide.
Recurrence is amenable to resection.
Performance status: ECOG ≤2.
Disqualifiers
Patients with history of abnormal left ventricular ejection fraction (LVEF≤ 45%).
Pregnant, breast-feeding, unwilling/unable to comply with contraception requirements.
Patients unable to consent.
Hemoglobin <10,
Trial design
Design model
Single group
Treatments tested in this trial
Afatinib
DrugAfatinib will be administered orally at a dose of 40 mg daily in patients with EGFR amplification.
Dasatinib
DrugDasatinib will be administered orally at a dose of 100 mg once daily in patients with PDGFR amplification.
Palbociclib
DrugPalbociclib will be administered orally at a dose of 125 mg once daily in patients with CDK4 and CDK6 amplification.
Everolimus
DrugEverolimus will be administered orally at a dose of 10 mg daily in patients with PI3K/PTEN/mTOR activated pathways.
Olaparib
DrugOlaparib will be administered orally at a dose of 300 mg twice daily in patients with TP53 mutation.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 5 interventions
Trial outcomes
Primary outcomes
1
Success rate of personalized GBM treatment based on molecular characterization of recurrent tumor
Percentage of patients, interested in participating, consented and detected with target mutations and completed the treatment with one of the 5 study drugs
Time frame
From date of initial consent to participate to the end of follow up period (24 months)Secondary outcomes
1
Overall survival (OS)
OS is calculated as the period from the day of starting administration of the study drug to the day of death from any cause.
Time frame
From date of study drug administration until date of death from any cause (approximately 24 months)2
Progression free survival (PFS)
PFS is calculated as the period from the day of starting administration of the study drug to the date that disease progression is confirmed by radiographic assessment and RANO criteria.
Time frame
From date of study drug administration until date of radiographic confirmed progression (approximately 2 years)3
Quality of Life (QoL) EORTC QLQ-C30
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.
Time frame
Baseline until the end of treatment4
Quality of Life (QoL) EORTC QLQ BN-20
Quality of Life measures are recorded according to EORTC QLQ BN-20 module, which is validated for brain tumor patients and measured as a unit of scale. This is a standard tool for assessing patient reported quality of Life along time during treatment. EORTC QLQ BN-20 (BN-20): 4 scales comprised of multiple items and 7 single items. All items are rated on a 4-point Likert-type scale, 1=not at all' to 4=very much, and linearly transformed to a 0-100 scale, higher scores indicating more severe symptoms. The scores across all time points were averaged to obtain the mean.
Time frame
Baseline until the end of treatmentOther outcomes
1
Genomic and expression profiling
Number of patients for whom we were able to have genomic and expression profiling on their tissue samples and organoids
Time frame
From date of initial consent to participate to end of follow up period (24 months)2
Organoid drug response
Number of patients for whom we can determine organoid drug response to study drugs
Time frame
From date of initial consent to participate to end of follow up period (24 months)3
Correlation of genomic and expression profiling of tissue and organoid with the organoid's best drug response
Number of patients for whom the genomic and expression profiling of their tissue and organoid directly correlates to the organoid's best drug response
Time frame
From date of initial consent to participate to end of follow up period (24 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
AHS Cancer Control Alberta
Lead sponsor
Tom Baker Cancer Centre
Collaborator
Source ClinicalTrials.gov