Individualized Systems Medicine Functional Profiling for Recurrent Glioblastoma

  • STATUS
    Recruiting
  • End date
    Feb 20, 2025
  • participants needed
    15
  • sponsor
    Oslo University Hospital
Updated on 20 September 2021

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).

Description

This protocol describes a prospective single-center phase 1 study to evaluate the feasibility and safety of a high-throughput drug sensitivity and resistance testing (HTS) platform of individualized cancer stem cells (CSC) to predict targeted therapies in patients with recurrence of GBM after standards-of-care. Secondary outcome include efficacy of drug treatment. The underlying hypotheses is that treatment of patients based on functional profiling og autologous CSCs using HTS a) is feasible within an acceptable time window for clinical translation, b) safely delay disease progression and c) increase survival. There are increasingly published literature that strongly support the importance of a targeting CSC to improve therapy and prevent tumor recurrence in GBM, as an additional strategy to improve the overall prognosis of patients.

Details
Condition Recurrent Glioblastoma
Treatment Personalized drug combination
Clinical Study IdentifierNCT05043701
SponsorOslo University Hospital
Last Modified on20 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 15 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 Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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