Individualized Systems Medicine Functional Profiling for Recurrent Glioblastoma

Recurrent Glioblastoma Clinical Trial

— ISM-GBM  

Official title:

Individualized Systems Medicine Strategy for Targeting Cancer Stem Cells in Patients With Recurrent Glioblastoma (ISM-GBM)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05043701
• Other study ID #: ISM-GBM
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 1, 2023
• Est. completion date: February 2026

Study information

• Verified date: April 2024
• Source: Oslo University Hospital
• Contact: Einar O. Vik-Mo, MD, PhD
• Phone: 23074343
• Email: uxvieb[@]ous-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: February 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Recurrence
• Recurrent Glioblastoma

Intervention

Drug:
• Personalized drug combination
A personalized drug combination will be prescribed to each patient based on the functional drug screen

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Institute for Molecular Medicine

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Number of grade 3-5 adverse events	Adverse events induced by selected treatments according to NCI Common Terminology Criteria for Adverse Events.	15 months from inclusion
Secondary	Overall survival	Overall survival in treated patients from time of second surgery to all-cause mortality.	15 months from inclusion
Secondary	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
Secondary	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