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| Name | Class |
|---|---|
| Institute for Molecular Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Patients will be treated with drugs based on functional profiling of autologous tumor cells in vitro |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized drug combination | Drug | A personalized drug combination will be prescribed to each patient based on the functional drug screen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Drug 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. | 8 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response | Tumor response by the chosen drug combination evaluated according to the updated response assessment in neuro-oncology (RANO) criteria. | 15 months from inclusion |
| Number of grade 3-5 adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Einar O. Vik-Mo, MD, PhD | Contact | 23074343 | +47 | uxvieb@ous-hf.no |
| Erlend Skaga, MD, PhD | Contact | 23074915 | +47 | erlend.skaga@medisin.uio.no |
| Name | Affiliation | Role |
|---|---|---|
| Einar O. Vik-Mo, MD, PhD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Recruiting | Oslo | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31889236 | Background | Skaga E, Kulesskiy E, Brynjulvsen M, Sandberg CJ, Potdar S, Langmoen IA, Laakso A, Gaal-Paavola E, Perola M, Wennerberg K, Vik-Mo EO. Feasibility study of using high-throughput drug sensitivity testing to target recurrent glioblastoma stem cells for individualized treatment. Clin Transl Med. 2019 Dec 30;8(1):33. doi: 10.1186/s40169-019-0253-6. | |
| 31238897 |
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Anonymized data will regarding tumor characteristics and results of functional profiling will be made available after publishing.
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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Open labelled intervention study
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Adverse events induced by selected treatments according to NCI Common Terminology Criteria for Adverse Events.
| 15 months from inclusion |
| Overall survival | Overall survival in treated patients from time of second surgery to all-cause mortality. | 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. | 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. | 15 months from inclusion |
| Skaga E, Kulesskiy E, Fayzullin A, Sandberg CJ, Potdar S, Kyttala A, Langmoen IA, Laakso A, Gaal-Paavola E, Perola M, Wennerberg K, Vik-Mo EO. Intertumoral heterogeneity in patient-specific drug sensitivities in treatment-naive glioblastoma. BMC Cancer. 2019 Jun 25;19(1):628. doi: 10.1186/s12885-019-5861-4. |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |