Back to results

Individualized Systems Medicine Functional Profiling for Recurrent Glioblastoma (ISM-GBM)

Primary Purpose

Recurrent Glioblastoma

Status

Recruiting

Phase

Early Phase 1

Locations

Norway

Study Type

Interventional

Intervention

Personalized drug combination

About this trial

This is an interventional treatment trial for Recurrent Glioblastoma focused on measuring functional screening, personalized treatment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 15 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

Sites / Locations

Oslo University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Tumor response

Tumor response by the chosen drug combination evaluated according to the updated response assessment in neuro-oncology (RANO) criteria.

Number of grade 3-5 adverse events

Adverse events induced by selected treatments according to NCI Common Terminology Criteria for Adverse Events.

Overall survival

Overall survival in treated patients from time of second surgery to all-cause mortality.

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.

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.

Full Information

NCT ID

NCT05043701

First Posted

June 7, 2021

Last Updated

March 19, 2023

Sponsor

Oslo University Hospital

Collaborators

Institute for Molecular Medicine

1. Study Identification

Unique Protocol Identification Number

NCT05043701

Brief Title

Individualized Systems Medicine Functional Profiling for Recurrent Glioblastoma

Acronym

ISM-GBM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 2023 (Anticipated)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oslo University Hospital

Collaborators

Institute for Molecular Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Glioblastoma

Keywords

functional screening, personalized treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Open labelled intervention study

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Personalized drug combination

Intervention Description

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

Primary Outcome Measure Information:

Title

Drug screen completion and treatment initiation

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.

Time Frame

8 weeks after surgery

Secondary Outcome Measure Information:

Title

Tumor response

Description

Tumor response by the chosen drug combination evaluated according to the updated response assessment in neuro-oncology (RANO) criteria.

Time Frame

15 months from inclusion

Title

Number of grade 3-5 adverse events

Description

Adverse events induced by selected treatments according to NCI Common Terminology Criteria for Adverse Events.

Time Frame

15 months from inclusion

Title

Overall survival

Description

Overall survival in treated patients from time of second surgery to all-cause mortality.

Time Frame

15 months from inclusion

Title

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

Description

Time Frame

15 months from inclusion

Title

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

Description

Time Frame

15 months from inclusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Einar O. Vik-Mo, MD, PhD

Phone

23074343

Ext

+47

uxvieb@ous-hf.no

First Name & Middle Initial & Last Name or Official Title & Degree

Erlend Skaga, MD, PhD

Phone

23074915

Ext

+47

erlend.skaga@medisin.uio.no

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Einar O. Vik-Mo, MD, PhD

Organizational Affiliation

Oslo University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oslo University Hospital

City

Oslo

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Einar O Vik-Mo, MD, PhD

Phone

+47 23074340

uxvieb@ous-hf.no

First Name & Middle Initial & Last Name & Degree

Solveig Bringsli

solbri@ous-hf.no

First Name & Middle Initial & Last Name & Degree

Einar O. Vik-Mo, MD, PhD

First Name & Middle Initial & Last Name & Degree

Petter Brandal, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Anonymized data will regarding tumor characteristics and results of functional profiling will be made available after publishing.

Citations:

PubMed Identifier

31889236

Citation

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.

Results Reference

background

PubMed Identifier

31238897

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.

Results Reference

background

Learn more about this trial

Individualized Systems Medicine Functional Profiling for Recurrent Glioblastoma

We'll reach out to this number within 24 hrs