RecruitingEarly Phase 1NCT05043701

Individualized Systems Medicine Functional Profiling for Recurrent Glioblastoma

Individualized Systems Medicine Strategy for Targeting Cancer Stem Cells in Patients With Recurrent Glioblastoma (ISM-GBM)


Sponsor

Oslo University Hospital

Enrollment

15 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

A study to determine the feasibility and safety of individualized cancer stem cell targeted therapy based on high-throughput functional profiling of FDA/EMA-approved drugs in patients with GBM that has recurred or progressed following standards-of-care (RT, TMZ).


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria7

  • Recurrence of histologically verified glioblastoma
  • Adequate biopsy to generate enough live cells to allow functional screening
  • Must be ambulatory with an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Must be 18 to 70 years of age
  • Adequate bone marrow, liver and heart function
  • Must be competent to give consent
  • Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to International Conference on Harmonization Good Clinical Practice guidelines (ICH GCP), and national/local regulations.

Exclusion Criteria2

  • Patients taking part in other clinical trials which could make inclusion or follow-up difficult
  • Any reason why, in the opinion of the investigator, the patient should not participate

Interventions

DRUGPersonalized drug combination

A personalized drug combination will be prescribed to each patient based on the functional drug screen


Locations(1)

Oslo University Hospital

Oslo, Norway

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NCT05043701


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