Study on the Effectiveness of Valganciclovir for Patients with Glioblastoma

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What is this study about?

This clinical trial is focused on studying the effects of the drug Valganciclovir in patients with glioblastoma, a type of brain cancer. Valganciclovir is an anti-viral medication that is being tested as an additional treatment alongside the standard therapy for this condition. The study will compare the outcomes of patients who receive Valganciclovir with those who do not, to see if it improves survival rates.

The purpose of the study is to evaluate whether adding Valganciclovir to the usual treatment can help patients live longer. Participants in the study will be randomly assigned to receive either Valganciclovir or a placebo, which looks like the Valganciclovir tablet but does not contain the active ingredient. The study will follow patients over a period of time to monitor their health and any side effects they may experience.

Throughout the study, patients will continue to receive their standard treatment, which typically includes radiation therapy and a chemotherapy drug called temozolomide. The trial aims to provide valuable information on whether Valganciclovir can be a beneficial addition to the current treatment options for glioblastoma patients.

1 joining the study

Upon joining the study, you will be required to provide written informed consent. This means you agree to participate after understanding the details and potential risks of the study.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying that you are 18 years or older, have a newly diagnosed glioblastoma, and meet other specific health criteria.

3 medication administration

You will receive either valganciclovir or a placebo. Valganciclovir is a medication taken orally. The dosage and frequency will be determined by the study team and will be explained to you in detail.

The medication will be administered as an add-on to your standard therapy, which includes radiation therapy combined with temozolomide.

4 regular monitoring

Throughout the study, you will undergo regular monitoring. This includes monthly pregnancy tests for females of child-bearing age due to the high potential of valganciclovir to cause birth defects.

Men are advised to use condoms with female partners during and for 6 months after treatment.

5 follow-up visits

You will have scheduled follow-up visits to assess your health and the effectiveness of the treatment. These visits will include various tests and evaluations as determined by the study protocol.

6 end of study

The study will conclude when the last participant has been followed for 30 months. Your overall survival time will be measured from the time of surgery until the end of the study or until any reason for discontinuation.

Who Can Join the Study?

Patients must be 18 years or older.
Patients must start their first dose of the study medication within 10 weeks after surgery.
Patients must have a newly diagnosed glioblastoma, which is a type of brain tumor.
Patients must have had a successful tumor removal surgery, with no more than 1 cm³ of the tumor remaining, as shown by a scan after surgery.
Patients must be eligible for standard treatment that includes radiation therapy and a medication called temozolomide.
Patients must have information available about the MGMT promoter methylation status of their tumor, which is a specific genetic feature.
Patients must have a Karnofsky Performance Status (KPS) of 70 or higher and an ECOG/WHO score of 2 or lower. These scores measure the patient’s ability to perform daily activities.
Patients must provide written informed consent, which means they agree to participate in the study after understanding all the details.
Patients must be cooperative and able to complete all study procedures.
Females of child-bearing age must have a negative pregnancy test at the start of the study and agree to use a highly effective birth control method during the study and for 6 months after the last dose of the study drug. This is important because the study drug can harm an unborn baby.
Men are recommended to use condoms with female partners who can become pregnant during the study and for 6 months after treatment with the study drug.

Who Cannot Join the Study?

Patients with a remaining tumor larger than 1 cm³ after surgery cannot participate.
Patients who have not been newly diagnosed with glioblastoma are excluded. Glioblastoma is a type of brain tumor.
Patients who are not receiving standard therapy for glioblastoma are excluded.
Patients who are unable to take the additional medication valganciclovir are excluded. Valganciclovir is a drug used to treat viral infections.
Patients who are part of a vulnerable population, such as those unable to give consent, are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country	Status
Karolinska University Hospital	Solna	Sweden
Srxlbaakp Uosjgxikty Hallbmwc Hu	Stavanger	Norway

Trial status

Country	Status	Recruitment Start
Norway	Not yet recruiting	04.09.2019
Sweden	Not yet recruiting	04.09.2019

Trial locations

Investigated drugs:

Valganciclovir

Valganciclovir is a medication being tested in this clinical trial as an additional treatment for patients with glioblastoma, a type of brain cancer. It is being used alongside the standard therapy that patients usually receive after surgery. The goal of using valganciclovir is to see if it can help improve the overall survival time of patients by reducing the size of any remaining tumor after surgery. This medication is being studied to determine if it can make the standard treatment more effective in prolonging the lives of patients with this aggressive form of cancer.

Investigated diseases:

Glioblastoma multiforme

Glioblastoma WHO Grade IV – Glioblastoma WHO Grade IV is an aggressive type of brain tumor that originates from glial cells, which support nerve cells in the brain. It is characterized by rapid growth and a tendency to infiltrate surrounding brain tissue, making it difficult to remove completely through surgery. The disease often presents with symptoms such as headaches, seizures, and neurological deficits, depending on the tumor’s location. As the tumor progresses, it can cause increased pressure within the skull, leading to further neurological complications. Glioblastoma is known for its high cellularity, necrosis, and microvascular proliferation, which contribute to its aggressive nature. The progression of the disease is marked by its ability to recur even after treatment, often with increased resistance to therapies.

Trial ID:

2023-504846-73-01

Protocol code:

Protocol number 8

NCT ID:

NCT04116411

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness of Valganciclovir for Patients with Glioblastoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?