Study on Gemcitabine for Patients with Recurrent Glioblastoma

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What is this study about?

This clinical trial focuses on studying Recurrent Glioblastoma, a type of brain cancer that has returned after treatment. The study will use a medication called Gemcitabine, which is given as a solution through an infusion, meaning it is delivered directly into the bloodstream. The purpose of the study is to explore a personalized approach to treating this cancer by targeting cancer stem cells, which are believed to be responsible for the growth and recurrence of tumors.

Participants in the study will undergo a process where their tumor cells are tested with various drugs to find the most effective treatment for their specific cancer. This approach is known as an Individualized Systems Medicine strategy. The study aims to determine if this method can successfully identify a treatment plan tailored to each patient’s unique cancer profile. The trial will also monitor the size of the tumor, any side effects from the treatments, and the overall survival of the patients involved.

The study will take place over a period of time, with the goal of completing by early 2026. During the trial, researchers will assess the ability to perform drug screenings and select possible treatment strategies based on the results. This innovative approach hopes to improve outcomes for patients with recurrent glioblastoma by providing more personalized and effective treatment options.

1 joining the study

Upon joining the study, you will be required to provide a signed informed consent. This document confirms your understanding of the study and your agreement to participate.

You will need to meet certain criteria, such as being between 18 to 70 years old, having a confirmed diagnosis of recurrent glioblastoma, and being able to perform daily activities with minimal assistance.

2 initial assessment

An initial assessment will be conducted to evaluate your overall health. This includes checking your bone marrow, liver, and heart function to ensure they are adequate for participation.

Your ability to move around and perform daily tasks will be assessed using a standard scale.

3 treatment planning

A personalized treatment plan will be developed based on a high-throughput drug screening of your tumor cells. This process aims to identify the most effective treatment strategy for you.

4 treatment administration

You will receive a medication called gemcitabine, which is administered as a solution for infusion. This means the medication is given through a needle directly into your bloodstream.

The dosage and frequency of the infusion will be determined by your healthcare team based on the results of the drug screening.

5 monitoring and follow-up

Throughout the study, your health and response to the treatment will be closely monitored. This includes regular assessments of tumor size and any side effects you may experience.

Your overall survival and response to the treatment will be evaluated and compared to the specific characteristics of your tumor.

6 completion of the study

The study is expected to continue until February 28, 2026. Upon completion, the results will be analyzed to determine the effectiveness of the personalized treatment strategy.

Who Can Join the Study?

Must have a histologically verified glioblastoma. This means the diagnosis of glioblastoma has been confirmed by examining tissue under a microscope.
Must be ambulatory with an ECOG performance status 0-1. This means the patient should be able to walk and carry out daily activities without help or with minimal symptoms.
Must be 18 to 70 years of age.
Must have adequate bone marrow, liver, and heart function. This means these organs are working well enough to participate in the study.
Must have signed informed consent. This means the patient agrees to participate in the study after being fully informed about it, and this agreement is documented according to guidelines and regulations.

Who Cannot Join the Study?

Patients who do not have Recurrent Glioblastoma cannot participate. This is a type of brain tumor that has come back after treatment.
Patients who are not within the specified age range cannot participate. The age range includes young adults and adults.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Norway	Recruiting	01.03.2024

Trial locations

Investigated drugs:

Gemcitabine

Individualized Systems Medicine (ISM) is a personalized treatment approach used in this clinical trial. It involves testing different drugs on tumor stem cell cultures taken from each patient’s cancer. The goal is to find the most effective medication for targeting cancer stem cells in patients with recurrent Glioblastoma. This method helps doctors choose a treatment that is specifically tailored to the patient’s unique cancer profile, potentially improving the effectiveness of the therapy.

Investigated diseases:

Recurrent Glioblastoma – Glioblastoma is a type of brain tumor that originates from glial cells, which support nerve cells in the brain. It is known for its aggressive nature and rapid growth. Recurrent glioblastoma refers to the return of the tumor after initial treatment. The disease progresses by infiltrating surrounding brain tissue, making it difficult to remove completely. As it grows, it can cause symptoms such as headaches, seizures, and neurological deficits depending on the tumor’s location. The recurrence of glioblastoma often involves more resistance to therapies and can lead to increased symptoms and complications.

Trial ID:

2023-510214-11-00

Protocol code:

ISM-GBM

NCT ID:

NCT05043701

Trial Phase:

Human Pharmacology (Phase I) – Other

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