Recurrent GlioblastomaEarly Phase 1ISM-GBMNCT05043701
Individualized Systems Medicine Functional Profiling for Recurrent Glioblastoma
A Early Phase 1 study testing Personalized drug combination in people with Recurrent Glioblastoma, run by Oslo University Hospital at 1 site in Norway.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Recurrent Glioblastoma
- What is being tested?
- Personalized drug combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2023to Feb 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo
Einar O Vik-Mo, MD, PhD, +47 23074340, uxvieb@ous-hf.no
Solveig Bringsli, solbri@ous-hf.no
About this study
Official title: Individualized Systems Medicine Strategy for Targeting Cancer Stem Cells in Patients With Recurrent Glioblastoma (ISM-GBM)
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).
Read the 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.
- Conditions
- Recurrent Glioblastoma
- Being tested
- Personalized drug combination
- Keywords
- functional screening, personalized treatment
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized drug combinationDrug
A personalized drug combination will be prescribed to each patient based on the functional drug screen
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients will be treated with drugs based on functional profiling of autologous tumor cells in vitro Receives: Drug: Personalized drug combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks after surgery
Secondary outcomes (5)
Tumor response
Tumor response by the chosen drug combination evaluated according to the updated response assessment in neuro-oncology (RANO) criteria.
Measured: 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.
Measured: 15 months from inclusion
Overall survival
Overall survival in treated patients from time of second surgery to all-cause mortality.
Measured: 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.
Measured: 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.
Measured: 15 months from inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start1 Mar 2023
- Primary completionDec 2024 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Recurrent GlioblastomaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open labelled intervention study
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Molecular Medicine
- Responsible party
- Principal investigator, Einar Vik-Mo, Oslo University Hospital
- Investigators
- Einar O. Vik-Mo, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043701
- Sponsor's protocol ID
- ISM-GBM
- Acronym
- ISM-GBM
- Status last verified
- Apr 2024
- First submitted
- 7 Jun 2021
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized data will regarding tumor characteristics and results of functional profiling will be made available after publishing.
Publications
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.
PubMed 31889236Skaga 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.
PubMed 31238897
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Systems Medicine Strategy for Targeting Cancer Stem Cells in Patients With Recurrent Glioblastoma (ISM-GBM)
- ClinicalTrials.gov ID
- NCT05043701
- Acronym / sponsor ID
- ISM-GBM / ISM-GBM
- Conditions
- Recurrent Glioblastoma
- Keywords
- functional screening, personalized treatment
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Institute for Molecular Medicine
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open labelled intervention study
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Personalized drug combinationPatients will be treated with drugs based on functional profiling of autologous tumor cells in vitro |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized drug combinationA personalized drug combination will be prescribed to each patient based on the functional drug screen | Drug | Treatment |
Primary outcome
Drug screen completion and treatment initiation
Time frame: 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.
5 secondary outcomes
Tumor response
Time frame: 15 months from inclusion
Number of grade 3-5 adverse events
Time frame: 15 months from inclusion
Overall survival
Time frame: 15 months from inclusion
Patient reported quality of life, overall (QLQ-C30)
Time frame: 15 months from inclusion
Patient reported quality of life, brain specific(QLQ-BN20)
Time frame: 15 months from inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Background: PubMed 31889236Skaga 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.
- Background: PubMed 31238897Skaga 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.
- Individual participant dataSharing planned: No. Anonymized data will regarding tumor characteristics and results of functional profiling will be made available after publishing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Einar O. Vik-Mo, MD, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Personalized drug combination in people with Recurrent Glioblastoma, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Einar O. Vik-Mo, MD, PhD (23074343 ext. +47, uxvieb@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug screen completion and treatment initiation (time frame: 8 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05043701, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.