Newly Diagnosed Glioblastoma
Conditions
Brief summary
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.
Detailed description
A panel of FDA approved drugs will be tested by high throughput screening, which is CLIA certified allowing for clinical decisions based on the results, to identify a combination of up to 3 drug candidates for treating individual patients. Lead candidates will be evaluated by pharmacists and a team of physicians, to confirm that prescribed drugs do not utilize pharmacological/ metabolic pathways that are known to increase the likelihood of toxicity, prior to initiating treatment. Investigational drug therapy, targeting CSCs, will be initiated alongside standard of care chemoradiation with TMZ.
Interventions
DRUGcombinations of up to 3 FDA approved drugs from a panel of compounds
personalized drug combinations
Sponsors
Swedish Medical Center
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single-center Phase 1 open-label study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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) * Patients must have a KPS rating of ≥70 * Patients should not have received any prior systemic anti-cancer therapy * Patients must be negative for HIV, Hepatitis B and C * Baseline hematologic studies and chemistry and coagulation profiles must meet the following criteria: * Hemoglobin (Hgb)\> 8 g/dL * Absolute Neutrophil Count (ANC) \> 1,000/mm3 * Platelet count \> 100,000/mm3 * Creatinine \< 2 mg/dL * Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \< 3x upper limit of normal (ULN)
Exclusion criteria
* Metastatic disease * Diseases or conditions that obscure toxicity or dangerously alter drug metabolism * Serious intercurrent medical illness * Inadequately controlled hypertension * History of myocardial infarction or unstable angina within 6 months * History of stroke or transient ischemic attack within 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| determine safety of CSC/HTS-based combination drug therapy | 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. | incidence of treatment-related AEs, laboratory abnormalities, and SAEs as assessed by CTCAE version 5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of CSC/HTS-based combination drug therapy | From inclusion in the study up to approximately 36 months | Response assessment per Response Assessment in Neuro-Oncology (RANO) criteria |
Countries
United States
Contacts
Primary ContactCharles S Cobbs, M.D.
Backup ContactParvinder Hothi, Ph.D.
Outcome results
None listed