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 because the information has not been verified recently.
Verified January 2009 by Karolinska University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT00400322
First received: November 15, 2006
Last updated: January 21, 2009
Last verified: January 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

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
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, see Learn About Clinical Studies.

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

No publications provided

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

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
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014