Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma

May 13, 2025 updated by: Swedish Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: combinations of up to 3 FDA approved drugs from a panel of compounds
personalized drug combinations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
determine safety of CSC/HTS-based combination drug therapy
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.
incidence of treatment-related AEs, laboratory abnormalities, and SAEs as assessed by CTCAE version 5.0
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of CSC/HTS-based combination drug therapy
Time Frame: From inclusion in the study up to approximately 36 months
Response assessment per Response Assessment in Neuro-Oncology (RANO) criteria
From inclusion in the study up to approximately 36 months
Efficacy of CSC/HTS-based combination drug therapy
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 months
Progression-free survival (PFS)
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 months
Efficacy of CSC/HTS-based combination drug therapy
Time Frame: From inclusion in the study until date of death from any cause, assessed up to approximately 36 months
Median overall survival (OS)
From inclusion in the study until date of death from any cause, assessed up to approximately 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swedish Medical Center

Investigators

  • Principal Investigator: Charles S Cobbs, Ivy Center for Advanced Brain Tumor Treatment

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 21, 2022

First Submitted That Met QC Criteria

May 17, 2022

First Posted (Actual)

May 18, 2022

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 161581

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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