CClinicalTrials.gg
Sign In
CompletedNCT00400322Updated Mar 1, 2021

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

An interventional study of Valganciclovir (Valcyte) and Placebo in Glioblastoma Multiforme and Cytomegalovirus Infection, sponsored by Karolinska Institutet. Completed at 3 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-01.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Aug 2006, registered Nov 2006).
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Glioblastoma Multiforme
  • Cytomegalovirus Infection

Keywords

  • glioblastoma multiforme
  • cytomegalovirus infection
  • antiviral treatment
  • valganciclovir
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 42 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Glioblastoma grade IV
  • Cytomegalovirus detected in tumor
  • At least 90% resection of tumor

Exclusion criteria

Exclusion Criteria:

  • Decreased kidney function
  • Pregnancy
  • Neutropenia
  • Thrombocytopenia
  • Patient not tolerating the drug
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
42 participants (actual)

Study arms

  • Active comparator
    Valganciclovir

    Drug: Valganciclovir (Valcyte)

  • Placebo comparator
    Placebo

    Other: Placebo

Interventions

  • DrugValganciclovir (Valcyte)
  • OtherPlacebo
06

What researchers measure

Primary outcomes

  1. Tumor size

    Time frame: Week twelve

  2. Tumor size

    Time frame: Week twenty four

Secondary outcomes

  1. Disease status

    Time frame: 24 months

  2. Patient survival

    Time frame: 24 months

07

Study locations

3 sites
  • Department of neurosurgery, Karolinska University Hospital
    Solna, Stockholm 17176, Sweden
  • Department of Oncology, Norrland University Hospital
    Umea, 901 85, Sweden
  • Department of Oncology, Akademiska Hospital
    Uppsala, 751 85, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00400322
Lead sponsor
Karolinska Institutet
Collaborators
Karolinska University Hospital
Responsible party
Cecilia Soderberg-Naucler (Professor, Karolinska Institutet) — Principal investigator
First posted
Nov 16, 2006
Start date
Aug 2006
Primary completion
Jun 2008
Completion
Jun 2008
Last update
Mar 1, 2021

Study contacts

Inti Peredo, MD
principal investigator · Karolinska University Hospital
Cecilia Soderberg-Naucler, MD, PhD
study chair · Karolinska Institutet
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Infections→

Other studies from this sponsor

Karolinska Institutet

Start the discussion