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

Karolinska Institutet42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Glioblastoma Multiforme Cytomegalovirus Infection

Interventions

Valganciclovir (Valcyte)DRUG

PlaceboOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Department of neurosurgery, Karolinska University Hospital

Solna, Stockholm County, Sweden

Department of Oncology, Norrland University Hospital

Umeå, Sweden

Department of Oncology, Akademiska Hospital

Uppsala, Sweden

Outcomes

Primary Outcomes

Tumor size

Time frame: Week twelve

Tumor size

Time frame: Week twenty four

Secondary Outcomes

Disease status

Time frame: 24 months

Patient survival

Time frame: 24 months

Data from ClinicalTrials.gov

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