Individualized Systems Medicine Functional Profiling for Recurrent Glioblastoma

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

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 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 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05043701
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Oslo University Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Einar O. Vik-Mo, MD, PhD
Principal Investigator Affiliation	Oslo University Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Norway
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Recurrent Glioblastoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: Treatment

Patients will be treated with drugs based on functional profiling of autologous tumor cells in vitro

Interventions

Drug: - Personalized drug combination

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Oslo University Hospital, Oslo, Norway

Status

Recruiting

Address

Oslo University Hospital

Oslo, ,

Site Contact

Einar O Vik-Mo, MD, PhD

[email protected]

+47 23074340

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