Glioblastoma MultiformeNCT00400322
Efficacy and Safety of Valcyte® as an add-on Therapy in Patients With Malignant Glioblastoma and Cytomegalovirus (CMV) Infection
A study testing Valganciclovir (Valcyte) in people with Glioblastoma Multiforme and Cytomegalovirus Infection, run by Karolinska Institutet at 3 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme, Cytomegalovirus Infection
- What is being tested?
- Valganciclovir (Valcyte)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 3 sitesSweden
- Study dates
- Aug 2006to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Glioblastoma grade IV
- Cytomegalovirus detected in tumor
- At least 90% resection of tumor
Who cannot join
- Decreased kidney function
- Pregnancy
- Neutropenia
- Thrombocytopenia
- Patient not tolerating the drug
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Department of neurosurgery, Karolinska University Hospital
Solna, Stockholm County, 17176
Department of Oncology, Norrland University Hospital
Umeå, 901 85
Department of Oncology, Akademiska Hospital
Uppsala, 751 85
About this study
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.
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.
- Conditions
- Glioblastoma Multiforme, Cytomegalovirus Infection
- Being tested
- Valganciclovir (Valcyte), Placebo
- Keywords
- glioblastoma multiforme, cytomegalovirus infection, antiviral treatment, valganciclovir
- Medical subject headings
- Glioblastoma, Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valganciclovir (Valcyte)Drug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Valganciclovir | Active comparator | Not described Receives: Drug: Valganciclovir (Valcyte) |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor size
Measured: Week twelve
Tumor size
Measured: Week twenty four
Secondary outcomes (2)
Disease status
Measured: 24 months
Patient survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2006 (estimated)
- Study startAug 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Cecilia Soderberg-Naucler, Karolinska Institutet
- Investigators
- Inti Peredo, MD, Principal investigator, Karolinska University HospitalCecilia Soderberg-Naucler, MD, PhD, Study chair, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400322
- Sponsor's protocol ID
- MV20145
- Other IDs
- 2006-002022-29
- Status last verified
- Feb 2021
- First submitted
- 15 Nov 2006
- Last updated
- 1 Mar 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00400322
- Acronym / sponsor ID
- MV20145
- Conditions
- Glioblastoma Multiforme, Cytomegalovirus Infection
- Keywords
- glioblastoma multiforme, cytomegalovirus infection, antiviral treatment, valganciclovir
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- Aug 2006 (actual)
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 16 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valganciclovir | Active comparator | Drug: Valganciclovir (Valcyte) |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Glioblastoma grade IV
- Cytomegalovirus detected in tumor
- At least 90% resection of tumor
Key exclusion criteria (5 listed)
- Decreased kidney function
- Pregnancy
- Neutropenia
- Thrombocytopenia
- Patient not tolerating the drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valganciclovir (Valcyte) | Drug | Valganciclovir |
| Placebo | Other | Placebo |
Primary outcome
Tumor size
Time frame: Week twelve
Tumor size
Time frame: Week twenty four
2 secondary outcomes
Disease status
Time frame: 24 months
Patient survival
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inti Peredo, MD principal investigator
Karolinska University Hospital
Cecilia Soderberg-Naucler, MD, PhD study chair
Karolinska Institutet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valganciclovir (Valcyte) in people with Glioblastoma Multiforme and Cytomegalovirus Infection, run by Karolinska Institutet at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor size (time frame: Week twelve). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.