Individualized Systems Medicine Functional Profiling for Recurrent Glioblastoma

NCT05043701 | Recruiting Early Phase 1 DMC

• 1 other identifier: ISM-GBM
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Recurrent Glioblastoma

Keywords

functional screening; personalized treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Tumor response

  15 months from inclusion

• Number of grade 3-5 adverse events

  15 months from inclusion

• Overall survival

  15 months from inclusion

• Patient reported quality of life, overall (QLQ-C30)

  15 months from inclusion

• Patient reported quality of life, brain specific(QLQ-BN20)

  15 months from inclusion

Study Arms (1)

Treatment

EXPERIMENTAL

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

Drug: Personalized drug combination

Interventions

Personalized drug combination DRUG

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

Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any reason why, in the opinion of the investigator, the patient should not participate

Sponsors & Collaborators

• Oslo University Hospital: lead
• Institute for Molecular Medicine: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

RECRUITING

Related 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.

  PMID: 31889236 BACKGROUND

• 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.

  PMID: 31238897 BACKGROUND

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Einar O. Vik-Mo, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Einar O. Vik-Mo, MD, PhD

CONTACT

23074343; uxvieb@ous-hf.no

Erlend Skaga, MD, PhD

CONTACT

23074915; erlend.skaga@medisin.uio.no

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Surgical Neuro-Oncology

Model Details: Open labelled intervention study

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: September 14, 2021
• Study Start: March 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2026
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)