Individualized Systems Medicine Functional Profiling for Recurrent Glioblastoma

NCT ID: NCT05043701

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2026-02-28

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.

Conditions

Recurrent Glioblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Patients will be treated with drugs based on functional profiling of autologous tumor cells in vitro

Group Type: EXPERIMENTAL

Personalized drug combination

Intervention Type: DRUG

A personalized drug combination will be prescribed to each patient based on the functional drug screen

Interventions

Personalized drug combination

A personalized drug combination will be prescribed to each patient based on the functional drug screen

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute for Molecular Medicine

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Einar Vik-Mo

Head of Surgical Neuro-Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Einar O. Vik-Mo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Oslo University Hospital

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Einar O. Vik-Mo, MD, PhD

Role: CONTACT

uxvieb@ous-hf.no

23074343 ext. +47

Erlend Skaga, MD, PhD

Role: CONTACT

erlend.skaga@medisin.uio.no

23074915 ext. +47

Facility Contacts

Einar O Vik-Mo, MD, PhD

Role: primary

uxvieb@ous-hf.no

+47 23074340

Solveig Bringsli

Role: backup

solbri@ous-hf.no

References

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.

Reference Type: BACKGROUND

PMID: 31889236 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31238897 (View on PubMed)

Other Identifiers

ISM-GBM

Identifier Type: -

Identifier Source: org_study_id