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

February 25, 2021 updated by: Cecilia Soderberg-Naucler, Karolinska Institutet

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Active Comparator: Valganciclovir
Drug: Valganciclovir (Valcyte)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor size
Time Frame: Week twelve
Week twelve
Tumor size
Time Frame: Week twenty four
Week twenty four

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease status
Time Frame: 24 months
24 months
Patient survival
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Karolinska University Hospital

Investigators

  • Principal Investigator: Inti Peredo, MD, Karolinska University Hospital
  • Study Chair: Cecilia Soderberg-Naucler, MD, PhD, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

November 15, 2006

First Submitted That Met QC Criteria

November 15, 2006

First Posted (Estimate)

November 16, 2006

Study Record Updates

Last Update Posted (Actual)

March 1, 2021

Last Update Submitted That Met QC Criteria

February 25, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MV20145
  • 2006-002022-29 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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