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NCT00400322 Clinical Trial

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

Glioblastoma Multiforme Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00400322
Other study ID # MV20145
Secondary ID 2006-002022-29
Status Completed
Phase N/A
First received
Last updated
Start date August 2006
Est. completion date June 2008

Study information
Verified date February 2021
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Valganciclovir (Valcyte)

Other:
• Placebo

Locations
Country Name City State
Sweden Department of neurosurgery, Karolinska University Hospital Solna Stockholm
Sweden Department of Oncology, Norrland University Hospital Umea
Sweden Department of Oncology, Akademiska Hospital Uppsala

Sponsors (2)
Lead Sponsor Collaborator
Karolinska Institutet Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tumor size Week twelve
Primary Tumor size Week twenty four
Secondary Disease status 24 months
Secondary Patient survival 24 months
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