Newly Diagnosed GlioblastomaEarly Phase 1NCT05380349
Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma
A Early Phase 1 study testing combinations of up to 3 FDA approved drugs from a panel of compounds in people with Newly Diagnosed Glioblastoma, run by Swedish Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Newly Diagnosed Glioblastoma
- What is being tested?
- combinations of up to 3 FDA approved drugs from a panel of compounds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2024to Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Swedish Medical Center
Seattle, Washington, 98122
Nathan Hansen, 206-320-3542, nathan.hansen@swedish.org
About this study
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
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.
Read the 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.
- Conditions
- Newly Diagnosed Glioblastoma
- Being tested
- combinations of up to 3 FDA approved drugs from a panel of compounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combinations of up to 3 FDA approved drugs from a panel of compoundsDrug
personalized drug combinations
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: combinations of up to 3 FDA approved drugs from a panel of compounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Response assessment per Response Assessment in Neuro-Oncology (RANO) criteria
Measured: From inclusion in the study up to approximately 36 months
Efficacy of CSC/HTS-based combination drug therapy
Progression-free survival (PFS)
Measured: 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
Median overall survival (OS)
Measured: From inclusion in the study until date of death from any cause, assessed up to approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start19 Apr 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- single-center Phase 1 open-label study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swedish Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles S Cobbs, Principal investigator, Ivy Center for Advanced Brain Tumor Treatment
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380349
- Sponsor's protocol ID
- 161581
- Status last verified
- May 2025
- First submitted
- 21 Apr 2022
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05380349
- Acronym / sponsor ID
- 161581
- Conditions
- Newly Diagnosed Glioblastoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Swedish Medical CenterUniversity, hospital or other
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-center Phase 1 open-label study
| Arm | Type | Receives |
|---|---|---|
| Personalized Combination Drug Therapy for Cancer Stem Cells | Experimental | Drug: combinations of up to 3 FDA approved drugs from a panel of compoundsAdminister combinations of up to 3 FDA approved drugs from a panel of compounds selected based on high throughput screening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combinations of up to 3 FDA approved drugs from a panel of compoundspersonalized drug combinations | Drug | Personalized Combination Drug Therapy for Cancer Stem Cells |
Primary outcome
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
3 secondary outcomes
Efficacy of CSC/HTS-based combination drug therapy
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles S Cobbs principal investigator
Ivy Center for Advanced Brain Tumor Treatment
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing combinations of up to 3 FDA approved drugs from a panel of compounds in people with Newly Diagnosed Glioblastoma, run by Swedish Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles S Cobbs, M.D. (206-320-2300, charles.cobbs@swedish.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.