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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
A personalized drug combination will be prescribed to each patient based on the functional drug screen
Oslo University Hospital
Oslo, Norway
RECRUITINGDrug screen completion and treatment initiation
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.
Time frame: 8 weeks after surgery
Tumor response
Tumor response by the chosen drug combination evaluated according to the updated response assessment in neuro-oncology (RANO) criteria.
Time frame: 15 months from inclusion
Number of grade 3-5 adverse events
Adverse events induced by selected treatments according to NCI Common Terminology Criteria for Adverse Events.
Time frame: 15 months from inclusion
Overall survival
Overall survival in treated patients from time of second surgery to all-cause mortality.
Time frame: 15 months from inclusion
Patient reported quality of life, overall (QLQ-C30)
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.
Time frame: 15 months from inclusion
Patient reported quality of life, brain specific(QLQ-BN20)
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.
Time frame: 15 months from inclusion
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