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.
2 other identifiers
interventional
42
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2006
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 15, 2006
CompletedFirst Posted
Study publicly available on registry
November 16, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedMarch 1, 2021
February 1, 2021
1.8 years
November 15, 2006
February 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Tumor size
Week twelve
Tumor size
Week twenty four
Secondary Outcomes (2)
Disease status
24 months
Patient survival
24 months
Study Arms (2)
Valganciclovir
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Glioblastoma grade IV
- Cytomegalovirus detected in tumor
- At least 90% resection of tumor
You may not qualify if:
- Decreased kidney function
- Pregnancy
- Neutropenia
- Thrombocytopenia
- Patient not tolerating the drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Karolinska University Hospitalcollaborator
Study Sites (3)
Department of neurosurgery, Karolinska University Hospital
Solna, Stockholm County, 17176, Sweden
Department of Oncology, Norrland University Hospital
Umeå, 901 85, Sweden
Department of Oncology, Akademiska Hospital
Uppsala, 751 85, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Inti Peredo, MD
Karolinska University Hospital
- STUDY CHAIR
Cecilia Soderberg-Naucler, MD, PhD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 15, 2006
First Posted
November 16, 2006
Study Start
August 1, 2006
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
March 1, 2021
Record last verified: 2021-02