Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioblastoma

Disease Attributes

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

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

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

Personalized drug combination

Einar O. Vik-Mo, MD, PhD

Erlend Skaga, MD, PhD

Einar O Vik-Mo, MD, PhD

Solveig Bringsli

Petter Brandal, MD, PhD

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).

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.

Individualized Systems Medicine Functional Profiling for Recurrent Glioblastoma

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

Anonymized data will regarding tumor characteristics and results of functional profiling will be made available after publishing.

The fraction of patient that can receive an individualized treatment based on drug screening. These drugs must be available for treatment and with a combined acceptable toxicity.

Tumor response by the chosen drug combination evaluated according to the updated response assessment in neuro-oncology (RANO) criteria.

Adverse events induced by selected treatments according to NCI Common Terminology Criteria for Adverse Events.

Overall survival in treated patients from time of second surgery to all-cause mortality.

Evaluated by Eastern Cooperative Oncology Group Quality of Life Questionaire (QLQ-C30), a questionnaire developed to assess the quality of life of cancer patients. Scale 30 to 120 points, where higher is worse.

Evaluated by Eastern Cooperative Oncology Group Quality of Life Questionaire, Brain module (QLQ-BN20). The brain cancer module is meant for use among brain cancer patients varying in disease stage and treatment modality. Scale 20 to 80 points, where higher is worse.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Individualized Systems Medicine Functional Profiling for Recurrent Glioblastoma	NCT05043701	Recurrent Gliob...	Personalized dr...	18 Years - 70 Years	Oslo University Hospital
Individualized Systems Medicine Functional Profiling for Recurrent Glioblastoma	NCT05043701	Recurrent Gliob...	Personalized dr...	18 Years - 70 Years	Oslo University Hospital

Spots Global Cancer Trial Database for functional screening