Clinical trial · Interventional
Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma
A Phase 1 Study of Combination Drug Therapy Based on Personalized Cancer Stem Cell (CSC) High-Throughput Drug Screening (HTS) With Standard of Care for Newly Diagnosed Glioblastoma
NCT05380349CI-TRIAL-00089855recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Newly Diagnosed Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| combinations of up to 3 FDA approved drugs from a panel of compounds | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Personalized Combination Drug Therapy for Cancer Stem Cells
- description
- Administer combinations of up to 3 FDA approved drugs from a panel of compounds selected based on high throughput screening
- interventionNames
- Drug: combinations of up to 3 FDA approved drugs from a panel of compounds
Primary outcomes (1)
- measure
- determine safety of CSC/HTS-based combination drug therapy
- timeFrame
- 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.
- description
- incidence of treatment-related AEs, laboratory abnormalities, and SAEs as assessed by CTCAE version 5.0
Secondary outcomes (3)
- measure
- Efficacy of CSC/HTS-based combination drug therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.