We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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