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OpenTrials
Completed

NCT Number: NCT00400322

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

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.

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Key information

Conditions

Glioblastoma Multiforme Astrocytoma Cytomegalovirus Infection Cytomegalovirus Infections DNA Virus Infections Glioblastoma Glioma Herpesviridae Infections Infections Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of neurosurgery, Karolinska University Hospital, Solna, Stockholm County, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valganciclovir (Valcyte)

Drug

Placebo

Other

Primary outcomes

  1. Tumor size

    Time frame: Week twelve

  2. Tumor size

    Time frame: Week twenty four

Secondary outcomes

  1. Disease status

    Time frame: 24 months

  2. Patient survival

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Karolinska University Hospital

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 16, 2006
Registry last updated
Mar 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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