Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma

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.

Conditions

Newly Diagnosed Glioblastoma

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Study Overview

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Study Details

Study overview

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.

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

Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma

Condition
Newly Diagnosed Glioblastoma
Intervention / Treatment

-

Contacts and Locations

Seattle

Swedish Medical Center, Seattle, Washington, United States, 98122

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Swedish Medical Center,

Charles S Cobbs, PRINCIPAL_INVESTIGATOR, Ivy Center for Advanced Brain Tumor Treatment

Study Record Dates

2027-12