Clinical trial · Interventional
Individualized Systems Medicine Functional Profiling for Recurrent Glioblastoma
Individualized Systems Medicine Strategy for Targeting Cancer Stem Cells in Patients With Recurrent Glioblastoma (ISM-GBM)
NCT05043701CI-TRIAL-00075647ISM-GBMunknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Personalized drug combination | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Patients will be treated with drugs based on functional profiling of autologous tumor cells in vitro
- interventionNames
- Drug: Personalized drug combination
Primary outcomes (1)
- measure
- Drug screen completion and treatment initiation
- timeFrame
- 8 weeks after surgery
- description
- 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 outcomes (5)
- measure
- Tumor response
- timeFrame
- 15 months from inclusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDSkaga 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. PMID 31889236
- BACKGROUNDSkaga 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. PMID 31238897