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

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ClinicalTrials.gov Identifier: NCT00400322
Recruitment Status : Unknown
Verified January 2009 by Karolinska University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 16, 2006
Last Update Posted : January 22, 2009
Sponsor:
Information provided by:
Karolinska University Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Glioblastoma Multiforme Cytomegalovirus Infection Drug: Valganciclovir (Valcyte) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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.
Study Start Date : August 2006
Estimated Study Completion Date : March 2009

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Tumor size [ Time Frame: week twelve and week twenty four ]

Secondary Outcome Measures :
  1. Disease status
  2. Patient survival

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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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
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Principal Investigator: Inti Peredo, MD Karolinska University Hospital
Study Chair: Cecilia Soderberg-Naucler, MD, PhD Karolinska Institutet
More Information
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ClinicalTrials.gov Identifier: NCT00400322     History of Changes
Other Study ID Numbers: MV20145
Eudra CT: 2006-002022-29
First Posted: November 16, 2006    Key Record Dates
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:
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Infection
Communicable Diseases
Cytomegalovirus Infections
Glioblastoma
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