Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma
ConditionNewly Diagnosed Glioblastoma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSwedish Medical Center
About this trial
Proposed treatment of subjects with newly diagnosed glioblastoma with novel personalized drug regimens identified to be effective in vitro using cancer stem cells derived from their individual tumors, alongside standard of care radiation and TMZ.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histological diagnosis of GBM (WHO grade 4)
Subjects ≥18 years of age
Patients must have a life expectancy of >6 months
Patients must have a surgically accessible tumor with the intent for a gross or near total resection of the tumor mass (GBM, WHO grade 4)
Disqualifiers
Metastatic disease
Diseases or conditions that obscure toxicity or dangerously alter drug metabolism
Serious intercurrent medical illness
Inadequately controlled hypertension
Trial design
Design model
Sequential
Treatments tested in this trial
combinations of up to 3 FDA approved drugs from a panel of compounds
Drugpersonalized drug combinations
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Personalized Combination Drug Therapy for Cancer Stem CellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
determine safety of CSC/HTS-based combination drug therapy
incidence of treatment-related AEs, laboratory abnormalities, and SAEs as assessed by CTCAE version 5.0
Time frame
From date of first dose of investigational drug regimen until date of first documented progression or death from any cause, whichever came first, assessed up to 24 months.Secondary outcomes
1
Efficacy of CSC/HTS-based combination drug therapy
Response assessment per Response Assessment in Neuro-Oncology (RANO) criteria
Time frame
From inclusion in the study up to approximately 36 months2
Efficacy of CSC/HTS-based combination drug therapy
Progression-free survival (PFS)
Time frame
From inclusion in the study until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 36 months3
Efficacy of CSC/HTS-based combination drug therapy
Median overall survival (OS)
Time frame
From inclusion in the study until date of death from any cause, assessed up to approximately 36 monthsSponsors and contacts
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Source ClinicalTrials.gov