Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma

Swedish Medical Center

Status and phase: Enrolling; Early Phase 1

Conditions: Newly Diagnosed Glioblastoma

Treatments: Drug: combinations of up to 3 FDA approved drugs from a panel of compounds

Study type: Interventional

Funder types: Other

Identifiers

NCT05380349

161581

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Personalized Combination Drug Therapy for Cancer Stem Cells

Experimental group

Description:

Administer combinations of up to 3 FDA approved drugs from a panel of compounds selected based on high throughput screening

Treatment:

Drug: combinations of up to 3 FDA approved drugs from a panel of compounds