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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified January 2009 by Karolinska University Hospital.
Recruitment status was: Active, not recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT00400322

First Posted: November 16, 2006

Last Update Posted: January 22, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Karolinska University Hospital

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:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment
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: Cytomegalovirus Infections

Drug Information available for: Valganciclovir hydrochloride

Genetic and Rare Diseases Information Center resources: Glioblastoma Cytomegalic Inclusion Disease Glioma Neuroepithelioma

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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400322

Locations


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

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


ClinicalTrials.gov Identifier:	NCT00400322 History of Changes
Other Study ID Numbers:	MV20145 Eudra CT: 2006-002022-29
First Submitted:	November 15, 2006
First Posted:	November 16, 2006
Last Update Posted:	January 22, 2009
Last Verified:	January 2009

Keywords provided by Karolinska University Hospital:


glioblastoma multiforme cytomegalovirus infection antiviral treatment valganciclovir

Additional relevant MeSH terms:


Infection Communicable Diseases Glioblastoma Cytomegalovirus Infections Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type	Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Herpesviridae Infections DNA Virus Infections Virus Diseases Valganciclovir Ganciclovir Antiviral Agents Anti-Infective Agents

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