Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma

NCT05380349 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 161581
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Newly Diagnosed Glioblastoma

Outcome Measures

Primary Outcomes (1)

• determine safety of CSC/HTS-based combination drug therapy

  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 Outcomes (3)

• Efficacy of CSC/HTS-based combination drug therapy

  From inclusion in the study up to approximately 36 months

• Efficacy of CSC/HTS-based combination drug therapy

  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

  From inclusion in the study until date of death from any cause, assessed up to approximately 36 months

Study Arms (1)

Personalized Combination Drug Therapy for Cancer Stem Cells

EXPERIMENTAL

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

Interventions

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

personalized drug combinations

Personalized Combination Drug Therapy for Cancer Stem Cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Swedish Medical Center: lead

Study Sites (1)

Swedish Medical Center

Seattle, Washington, 98122, United States

RECRUITING

Study Officials

• Charles S Cobbs

  Ivy Center for Advanced Brain Tumor Treatment

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles S Cobbs, M.D.

CONTACT

206-320-2300; charles.cobbs@swedish.org

Parvinder Hothi, Ph.D.

CONTACT

206-320-3145; parvinder.hothi@swedish.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-center Phase 1 open-label study

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 18, 2022
• Study Start: April 19, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)