Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-19

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

SCH-900105 in Recurrent Glioblastoma

NCT01189513

Glioblastoma

WITHDRAWN PHASE1

Stem Cell Transplant for High Risk Central Nervous System (CNS) Tumors

NCT00179803

Glioblastoma Astrocytoma Pineoblastoma +2 more

COMPLETED PHASE2

Dose Finding Study of [177Lu]Lu-NeoB in Newly Diagnosed Glioblastoma and in Recurrent Glioblastoma

NCT05739942

Newly Diagnosed and Recurrent Glioblastoma

ACTIVE_NOT_RECRUITING PHASE1

TRC105 for Recurrent Glioblastoma

NCT01778530

Glioblastoma Multiforme

TERMINATED PHASE2

Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade

NCT03493932

Glioblastoma

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Newly Diagnosed Glioblastoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SEQUENTIAL

single-center Phase 1 open-label study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

personalized drug combinations

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

personalized drug combinations

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No