Recurrent Glioblastoma
Conditions
Keywords
functional screening, personalized treatment
Brief 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).
Detailed 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.
Interventions
DRUGPersonalized drug combination
A personalized drug combination will be prescribed to each patient based on the functional drug screen
Sponsors
Institute for Molecular Medicine
Oslo University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open labelled intervention study
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drug screen completion and treatment initiation | 8 weeks after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor response | 15 months from inclusion | Tumor response by the chosen drug combination evaluated according to the updated response assessment in neuro-oncology (RANO) criteria. |
| Number of grade 3-5 adverse events | 15 months from inclusion | Adverse events induced by selected treatments according to NCI Common Terminology Criteria for Adverse Events. |
| Overall survival | 15 months from inclusion | Overall survival in treated patients from time of second surgery to all-cause mortality. |
| Patient reported quality of life, overall (QLQ-C30) | 15 months from inclusion | 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. |
| Patient reported quality of life, brain specific(QLQ-BN20) | 15 months from inclusion | 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. |
Countries
Norway
Contacts
Primary ContactEinar O. Vik-Mo, MD, PhD
Backup ContactErlend Skaga, MD, PhD
Outcome results
None listed