Efficacy and Safety of Valcyte® as an add-on Therapy in Patients With Malignant Glioblastoma and Cytomegalovirus (CMV) Infection

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00400322

Enrollment

Registered

2006-11-16

Start date

2006-08-31

Completion date

2008-06-30

Last updated

2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytomegalovirus Infection, Glioblastoma Multiforme

Keywords

glioblastoma multiforme, cytomegalovirus infection, antiviral treatment, valganciclovir

Brief summary

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.

Interventions

DRUGValganciclovir (Valcyte)

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Glioblastoma grade IV * Cytomegalovirus detected in tumor * At least 90% resection of tumor

Exclusion criteria

* Decreased kidney function * Pregnancy * Neutropenia * Thrombocytopenia * Patient not tolerating the drug

Design outcomes

Primary

Measure	Time frame
Tumor size	Week twelve

Secondary

Measure	Time frame
Disease status	24 months
Patient survival	24 months

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026