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Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05380349
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Swedish Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Charles S Cobbs
Principal Investigator Affiliation Ivy Center for Advanced Brain Tumor Treatment
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Newly Diagnosed Glioblastoma
Additional Details

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.

Arms & Interventions

Arms

Experimental: Personalized Combination Drug Therapy for Cancer Stem Cells

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

Interventions

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

personalized drug combinations

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Swedish Medical Center, Seattle, Washington

Status

Recruiting

Address

Swedish Medical Center

Seattle, Washington, 98122

Site Contact

Nathan Hansen

[email protected]

206-320-3542

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