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A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients

NCT ID: NCT04116411

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-04

Study Completion Date

2027-09-16

Brief Summary

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This study is a multicenter randomized double-blinded controlled phase 2 study evaluating the efficacy and safety of the anti-CMV drug valganciclovir vs placebo as add-on therapy in patients with glioblastoma. Valganciclovir is approved for treatment of cytomegalovirus (CMV) infections, but may also have anti-tumoral effects. Current evidence imply that most glioblastomas are CMV positive and that the virus can affect tumor aggressiveness.

Detailed Description

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Adult patients will either be randomized to standard treatment (temozolomide and radiation therapy) + placebo tablets or to standard treatment + valganciclovir. Patients are randomized using 1 to 1 distribution of the patients between the treatment groups and are stratified according to methylation status of the MGMT promoter; equal proportion of patients are included in each group. A maximum of 30% of patients with methylated MGMT promoter are allowed into the study (to harmonise with current data used for statistical power calculation), as MGMT promotor methylation status is prognostic for patient survival. Patients must enter the study within 10 weeks after surgery.

Full dose treatment with 900mgs of Valganciclovir is given twice daily for 6 weeks, thereafter 900 mgs daily during 98 weeks (total treatment of 24 months). Valganciclovir is available in 450 mg tablets. The dose of Valganciclovir will be adjusted according to renal function.

This study will be performed in compliance with the protocol, ICH-GCP, the declaration of Helsinki and applicable Swedish regulatory requirements.

The study discontinuation criteria are as follows:

* Withdrawal of consent
* An adverse event which requires discontinuation of the trial medication or results in
* inability to continue to comply with trial procedures
* Disease progression which results in inability to continue to comply with trial
* procedures
* Major Protocol deviations
* Exclusion criteria met

Conditions

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Glioblastoma Multiforme

Keywords

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cytomegalovirus valganciclovir

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A multicenter randomized double-blinded controlled phase 2 study evaluating the efficacy of valganciclovir as add-on therapy in glioblastoma patients. Patients will receive either placebo or valganciclovir according to a randomisation list, blinded to the sponsor and study team. Seven centers are aimed to include patients once approval is received for each respective study center.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
VIGAS 2 is conducted under a randomised double blinded protocol. The study team and the patients are blinded to the randomisation list. Randomisation is performed by the contracted Clinical Cancer Center Unit at the Karolinska University Hospital by an unblinded person, Claudia Maes who holds responsibility to select out number codes for coded cans of the study drug. Claudia Maes is unrelated to the sponsor and the study team.

Study Groups

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Placebo

Patients will receive placebo tablets with similar appearance as the active drug. Patients receive two 450 mg tablets twice daily taken per orally for 6 weeks, thereafter two 450 mg tablet once daily for an additional 22.5 months; a total treatment time of 24 months.

Group Type PLACEBO_COMPARATOR

Temozolomide 120 mg

Intervention Type DRUG

Chemotherapy

Radiotherapy 60 Gy

Intervention Type RADIATION

Radiation therapy

Placebo oral tablet

Intervention Type DRUG

Placebo treatment of glioblastoma

Valganciclovir

Patients will receive valganciclovir tablets with similar appearance as the placebo tablets. Patients receive two 450 mg valganciclovir tablets twice daily taken per orally for 6 weeks, thereafter two 450 mg valganciclovir tablets once daily for an additional 22.5 months; a total treatment time of 24 months.

Group Type ACTIVE_COMPARATOR

Valganciclovir Tablets

Intervention Type DRUG

Valganciclovir treatment of glioblastoma

Temozolomide 120 mg

Intervention Type DRUG

Chemotherapy

Radiotherapy 60 Gy

Intervention Type RADIATION

Radiation therapy

Interventions

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Valganciclovir Tablets

Valganciclovir treatment of glioblastoma

Intervention Type DRUG

Temozolomide 120 mg

Chemotherapy

Intervention Type DRUG

Radiotherapy 60 Gy

Radiation therapy

Intervention Type RADIATION

Placebo oral tablet

Placebo treatment of glioblastoma

Intervention Type DRUG

Other Intervention Names

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Valcyte ValGANcilovir Valganciclovir 450 mg J05AB14 Valganciclovir oral Temozolomide pill Temozolomide tablet Radiation Placebos

Eligibility Criteria

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Inclusion Criteria

1. Patients aged 18 years or older
2. Patients with newly diagnosed glioblastoma, IDH 1 wt, WHO grade IV
3. Radical resection
4. Concomitant treatment with temozolomide and radiation therapy
5. MGMT promoter methylation status
6. Patients with at least KPS 70 , ECOG/WHO 2
7. Patients providing written informed consent
8. Patients cooperative and able to complete all the assessment procedures.
9. Females of child-bearing age must have a negative pregnancy test at screening (all premenopausal women, or in case when menstrual status can not be ascertained in women under the age of 55). Female patient must agree to utilize a highly efficient birth control method throughout the study period (Pearl index \<1, e.g: oral contraception with gestagens, transdermal contraceptives, implants, injectables, intrauterine devices, bilateral tubal occlusion, sexual abstinence or vasectomised partner). The birth control method must be used at least 30 days after treatment end. Pregnancy testing should be performed at monthly intervals due to high teratogenic potential of valganciclovir. Men are recommended to use condoms with female partners during, and for at least 90 days following treatment with Valganciclovir.
10. Patients must be enrolled within 10 weeks after surgery

Exclusion Criteria

1. Patients allergic to, or who do not tolerate Valganciclovir, aciclovir or valaciclovir treatment
2. Patients with decreased cognitive function (below 24 in MMSE test)
3. Pregnant or lactating females
4. Patients not signing informed consent
5. Patient is simultaneously participating in another experimental drug therapy trial
6. Neutrophil count \< 1,5 cells/ 109/L
7. Platelet count \< 150 cells/ 109/L
8. HGB \< 80 g/L
9. Abnormal renal function (GFR \< 30)
10. Secondary glioblastoma, or glioblastoma IDH1 mutated.
11. Unfit for any other reason judged by investigator
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

Cecilia Soderberg-Naucler

OTHER

Sponsor Role lead

Responsible Party

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Cecilia Soderberg-Naucler

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Giuseppe Stragliotto, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Stavanger University Hospital

Stavanger, , Norway

Site Status

SE01 Karolinska University Hospital

Solna, Stockholm County, Sweden

Site Status

Countries

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Norway Sweden

References

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Peredo I, Hellden A, Wolmer-Solberg N, Pohanka A, Stragliotto G, Rahbar A, Stahle L, Bellander BM, Soderberg-Naucler C. Ganciclovir concentrations in the cerebral extracellular space after valganciclovir treatment; a case study. BMJ Case Rep. 2015 Dec 15;2015:bcr2014207694. doi: 10.1136/bcr-2014-207694.

Reference Type BACKGROUND
PMID: 26670887 (View on PubMed)

Rahbar A, Orrego A, Peredo I, Dzabic M, Wolmer-Solberg N, Straat K, Stragliotto G, Soderberg-Naucler C. Human cytomegalovirus infection levels in glioblastoma multiforme are of prognostic value for survival. J Clin Virol. 2013 May;57(1):36-42. doi: 10.1016/j.jcv.2012.12.018. Epub 2013 Feb 4.

Reference Type BACKGROUND
PMID: 23391370 (View on PubMed)

Cobbs CS. Does valganciclovir have a role in glioblastoma therapy? Neuro Oncol. 2014 Mar;16(3):330-1. doi: 10.1093/neuonc/nou009. No abstract available.

Reference Type BACKGROUND
PMID: 24523453 (View on PubMed)

Stragliotto G, Rahbar A, Solberg NW, Lilja A, Taher C, Orrego A, Bjurman B, Tammik C, Skarman P, Peredo I, Soderberg-Naucler C. Effects of valganciclovir as an add-on therapy in patients with cytomegalovirus-positive glioblastoma: a randomized, double-blind, hypothesis-generating study. Int J Cancer. 2013 Sep 1;133(5):1204-13. doi: 10.1002/ijc.28111. Epub 2013 Mar 13.

Reference Type RESULT
PMID: 23404447 (View on PubMed)

Soderberg-Naucler C, Peredo I, Stragliotto G. Valganciclovir in patients with glioblastoma. N Engl J Med. 2013 Nov 21;369(21):2066-7. doi: 10.1056/NEJMc1312413. No abstract available.

Reference Type RESULT
PMID: 24256396 (View on PubMed)

Merchut-Maya JM, Bartek J Jr, Bartkova J, Galanos P, Pantalone MR, Lee M, Cui HL, Shilling PJ, Brochner CB, Broholm H, Maya-Mendoza A, Soderberg-Naucler C, Bartek J. Human cytomegalovirus hijacks host stress response fueling replication stress and genome instability. Cell Death Differ. 2022 Aug;29(8):1639-1653. doi: 10.1038/s41418-022-00953-w. Epub 2022 Feb 22.

Reference Type DERIVED
PMID: 35194187 (View on PubMed)

Other Identifiers

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Eudra CT: 2019-001083-30

Identifier Type: -

Identifier Source: org_study_id