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Combination Drug Therapy for Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma

Primary Purpose

Newly Diagnosed Glioblastoma

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
combinations of up to 3 FDA approved drugs from a panel of compounds
Sponsored by
Swedish Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Newly Diagnosed Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Personalized Combination Drug Therapy for Cancer Stem Cells

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Efficacy of CSC/HTS-based combination drug therapy
    Response assessment per Response Assessment in Neuro-Oncology (RANO) criteria
    Efficacy of CSC/HTS-based combination drug therapy
    Progression-free survival (PFS)
    Efficacy of CSC/HTS-based combination drug therapy
    Median overall survival (OS)

    Full Information

    First Posted
    April 21, 2022
    Last Updated
    January 19, 2023
    Sponsor
    Swedish Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05380349
    Brief Title
    Combination Drug Therapy for Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    March 2025 (Anticipated)
    Study Completion Date
    March 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Swedish Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Newly Diagnosed Glioblastoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Sequential Assignment
    Model Description
    single-center Phase 1 open-label study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Personalized Combination Drug Therapy for Cancer Stem Cells
    Arm Type
    Experimental
    Arm Description
    Administer combinations of up to 3 FDA approved drugs from a panel of compounds selected based on high throughput screening
    Intervention Type
    Drug
    Intervention Name(s)
    combinations of up to 3 FDA approved drugs from a panel of compounds
    Intervention Description
    personalized drug combinations
    Primary Outcome Measure Information:
    Title
    determine safety of CSC/HTS-based combination drug therapy
    Description
    incidence of treatment-related AEs, laboratory abnormalities, and SAEs as assessed by CTCAE version 5.0
    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.
    Secondary Outcome Measure Information:
    Title
    Efficacy of CSC/HTS-based combination drug therapy
    Description
    Response assessment per Response Assessment in Neuro-Oncology (RANO) criteria
    Time Frame
    From inclusion in the study up to approximately 36 months
    Title
    Efficacy of CSC/HTS-based combination drug therapy
    Description
    Progression-free survival (PFS)
    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
    Title
    Efficacy of CSC/HTS-based combination drug therapy
    Description
    Median overall survival (OS)
    Time Frame
    From inclusion in the study until date of death from any cause, assessed up to approximately 36 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Charles S Cobbs, M.D.
    Phone
    206-320-2300
    Email
    charles.cobbs@swedish.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Parvinder Hothi, Ph.D.
    Phone
    206-320-2300
    Email
    parvinder.hothi@swedish.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charles S Cobbs
    Organizational Affiliation
    Ivy Center for Advanced Brain Tumor Treatment
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Combination Drug Therapy for Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma

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