Completed

A Randomized Double Blind Controlled Proof of Concept Study of the Efficacy and Safety of Valcyte® as an add-on Therapy in Patients With Malignant Glioblastoma With Successful Surgical Resection of at Least 90 % of the Initial Tumor and CMV Infection Demonstrated Histologically and Immunohistochemically.

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Valganciclovir (Valcyte)

+ Placebo

DrugOther
Who is being recruted

Astrocytoma+12

+ Cytomegalovirus Infections

+ DNA Virus Infections

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: August 2006
See protocol details

Summary

Principal SponsorKarolinska Institutet
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2006

Actual date on which the first participant was enrolled.

The purpose of this study is to investigate if treatment of CMV infection by antiviral drug Valcyte (R) affects the clinical outcome of glioblastoma multiforme in patients with local CMV infection in tumor tissue. The investigators' hypothesis states that CMV infection promotes tumor development and disease progression and inhibits immune responses against the tumor.

Official TitleA Randomized Double Blind Controlled Proof of Concept Study of the Efficacy and Safety of Valcyte® as an add-on Therapy in Patients With Malignant Glioblastoma With Successful Surgical Resection of at Least 90 % of the Initial Tumor and CMV Infection Demonstrated Histologically and Immunohistochemically.
NCT00400322
Principal SponsorKarolinska Institutet
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

42 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AstrocytomaCytomegalovirus InfectionsDNA Virus InfectionsGlioblastomaGliomaHerpesviridae InfectionsInfectionsNeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueVirus DiseasesNeuroectodermal TumorsNeoplasms, Neuroepithelial

Criteria

3 inclusion criteria required to participate
Glioblastoma grade IV
Cytomegalovirus detected in tumor
At least 90% resection of tumor
5 exclusion criteria prevent from participating
Decreased kidney function
Pregnancy
Neutropenia
Thrombocytopenia
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Department of neurosurgery, Karolinska University Hospital

Solna, SwedenOpen Department of neurosurgery, Karolinska University Hospital in Google Maps
Suspended

Department of Oncology, Norrland University Hospital

Umeå, Sweden
Suspended

Department of Oncology, Akademiska Hospital

Uppsala, Sweden
Completed3 Study Centers