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

Karolinska Institute

Status: Completed

Conditions: Glioblastoma Multiforme; Cytomegalovirus Infection

Treatments: Other: Placebo; Drug: Valganciclovir (Valcyte)

Study type: Interventional

Funder types: Other

Identifiers

NCT00400322

MV20145

2006-002022-29 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups, including a placebo group

Valganciclovir

Active Comparator group

Treatment:

Drug: Valganciclovir (Valcyte)

Placebo

Placebo Comparator group

Treatment:

Other: Placebo