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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 : Completed
First Posted : November 16, 2006
Last Update Posted : March 1, 2021
Sponsor:
Collaborator:
Karolinska University Hospital
Information provided by (Responsible Party):
Cecilia Soderberg-Naucler, Karolinska Institutet

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) Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 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.
Actual Study Start Date : August 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008


Arm Intervention/treatment
Active Comparator: Valganciclovir Drug: Valganciclovir (Valcyte)
Placebo Comparator: Placebo Other: Placebo



Primary Outcome Measures :
  1. Tumor size [ Time Frame: Week twelve ]
  2. Tumor size [ Time Frame: Week twenty four ]

Secondary Outcome Measures :
  1. Disease status [ Time Frame: 24 months ]
  2. Patient survival [ Time Frame: 24 months ]


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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

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
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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 Institutet
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
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Responsible Party: Cecilia Soderberg-Naucler, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT00400322    
Other Study ID Numbers: MV20145
2006-002022-29 ( EudraCT Number )
First Posted: November 16, 2006    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021
Keywords provided by Cecilia Soderberg-Naucler, Karolinska Institutet:
glioblastoma multiforme
cytomegalovirus infection
antiviral treatment
valganciclovir
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Cytomegalovirus Infections
Glioblastoma
Disease Attributes
Pathologic Processes
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