RECRUITING

Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-04-19
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05380349

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histological diagnosis of GBM (WHO grade 4)
  2. * Subjects ≥18 years of age
  3. * Patients must have a life expectancy of \>6 months
  4. * 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)
  5. * Patients must have a KPS rating of ≥70
  6. * Patients should not have received any prior systemic anti-cancer therapy
  7. * Patients must be negative for HIV, Hepatitis B and C
  8. * Baseline hematologic studies and chemistry and coagulation profiles must meet the following criteria:
  9. * Hemoglobin (Hgb)\> 8 g/dL
  10. * Absolute Neutrophil Count (ANC) \> 1,000/mm3
  11. * Platelet count \> 100,000/mm3
  12. * Creatinine \< 2 mg/dL
  13. * Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \< 3x upper limit of normal (ULN)
  1. * Metastatic disease
  2. * Diseases or conditions that obscure toxicity or dangerously alter drug metabolism
  3. * Serious intercurrent medical illness
  4. * Inadequately controlled hypertension
  5. * History of myocardial infarction or unstable angina within 6 months
  6. * History of stroke or transient ischemic attack within 6 months

Contacts and Locations

Study Contact

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

Principal Investigator

Charles S Cobbs
PRINCIPAL_INVESTIGATOR
Ivy Center for Advanced Brain Tumor Treatment

Study Locations (Sites)

Swedish Medical Center
Seattle, Washington, 98122
United States

Collaborators and Investigators

Sponsor: Swedish Medical Center

  • Charles S Cobbs, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2024-04-19
Study Completion Date2027-12

Study Record Updates

Study Start Date2024-04-19
Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

  • Newly Diagnosed Glioblastoma