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

This study is ongoing, but not recruiting participants.

First Received: November 15, 2006 Last Updated: January 21, 2009 History of Changes

Sponsored by:	Karolinska University Hospital
Information provided by:	Karolinska University Hospital
ClinicalTrials.gov Identifier:	NCT00400322

Purpose

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.

Condition	Intervention
Glioblastoma Multiforme Cytomegalovirus Infection	Drug: Valganciclovir (Valcyte)

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cytomegalovirus Infections

Drug Information available for: Valganciclovir hydrochloride Valganciclovir

U.S. FDA Resources

Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:

Tumor size [ Time Frame: week twelve and week twenty four ]

Secondary Outcome Measures:

Disease status
Patient survival

Estimated Enrollment:	40
Study Start Date:	August 2006
Estimated Study Completion Date:	March 2009

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400322

Locations

Sweden
Department of Oncology, Norrland University Hospital
Umea, Sweden, 901 85
Department of Oncology, Akademiska Hospital
Uppsala, Sweden, 751 85
Sweden, Stockholm
Department of neurosurgery, Karolinska University Hospital
Solna, Stockholm, Sweden, 17176

Sponsors and Collaborators

Karolinska University Hospital

Investigators

Principal Investigator:	Inti Peredo, MD	Karolinska University Hospital
Study Chair:	Cecilia Soderberg-Naucler, MD, PhD	Karolinska Institutet

More Information

No publications provided

Study ID Numbers:	MV20145, Eudra CT: 2006-002022-29
Study First Received:	November 15, 2006
Last Updated:	January 21, 2009
ClinicalTrials.gov Identifier:	NCT00400322 History of Changes
Health Authority:	Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board

Keywords provided by Karolinska University Hospital:

glioblastoma multiforme
cytomegalovirus infection
antiviral treatment
valganciclovir

Study placed in the following topic categories:

Anti-Infective Agents
Glioblastoma
Astrocytoma
Valganciclovir
Antiviral Agents
Cytomegalovirus
Herpesviridae Infections
Virus Diseases
Neuroectodermal Tumors

Neoplasms, Germ Cell and Embryonal
Cytomegalic Inclusion Disease
Neuroepithelioma
Cytomegalovirus Infections
DNA Virus Infections
Glioma
Glioblastoma Multiforme
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Anti-Infective Agents
Communicable Diseases
Glioblastoma
Neoplasms by Histologic Type
Astrocytoma
Valganciclovir
Neoplasms, Nerve Tissue
Infection
Antiviral Agents
Pharmacologic Actions
Herpesviridae Infections

Virus Diseases
Neuroectodermal Tumors
Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Cytomegalovirus Infections
DNA Virus Infections
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 03, 2009